Abstract of the thesis entitled An evidence-based ... Lai Fan.pdf · Abstract of the thesis...
Transcript of Abstract of the thesis entitled An evidence-based ... Lai Fan.pdf · Abstract of the thesis...
I
Abstract of the thesis entitled
An evidence-based guideline of performing massage by labour
companion to improve labour outcomes
Submitted by
TSE LAI FAN
For the Degree of Master of Nursing
At the University of Hong Kong
In August 2015
The number of labouring women using pharmacological pain relief methods had
increased dramatically in recent years. However, the pharmacological pain relief
methods not only bring side effects on labour women but also on the newborns. In
order to improve labouring women pain relief process, there is a need to develop a
comprehensive, user friendly and evidence-based guideline for promoting massage as
a non-pharmacological pain relief method for relieving labour pain. Traditional
pharmacological pain relief methods are associated with different side effects such as
nausea and vomiting on maternal and respiratory distress on neonatal. Recent
researches documented that using massage which performed by labour companions
not only can reduce labour pain but also reduce anxiety and increase satisfaction of
labouring women. Therefore, this translational research aims to evaluate the current
practice on the effect of adopting massage program to formulate an evidence-based
guideline, assess its implementation potential and to develop an implementation and
evaluation plan.
II
Five selected literature were retrieved from three electronic bibliographic databases.
In order to ensure the quality and validity of the selected evidences, critical appraisal
had been done. Based upon the information from the identified literature, a clinical
guideline is developed. The implementation potential is assessed based on the
similarity and the readiness of the target setting to the proposed environment. The
transferability of the protocol was high and it was feasible to be implemented into the
target ward.
An implementation plan was then planned which included the communication plan
with all the stakeholders. A pilot study will be carried out for examining the readiness
before the full scale implementation of the program after reaching a consensus among
the stakeholders.
The evaluation plan of the effectiveness of the proposed program is developed. The
implementation of this labour companion-led massage program is suggested to be
worthy of adopting in the clinical setting for bringing benefits such as decreasing
labour pain or anxiety to labouring women, decreasing the workload to the staff and
decreasing expenditure on pharmacological pain relief in the hospital.
III
An evidence-based guideline of performing massage
by labour companion to improve labour outcomes
By
TSE LAI FAN
(B. Nurs. H.K.U.)
A thesis submitted in partial fulfillment of the requirement for
the Degree of Master of Nursing
at the University of Hong Kong
August, 2015
IV
Declaration
I declare that this dissertation represents my own work, except where due
acknowledgment is made, and that is has not been previously included in a thesis,
dissertation or report submitted to this university or to any other institution for a
degree, diploma or other qualifications.
Signed:
TSE LAI FAN
V
Acknowledgment
I would like to show my sincere gratitude to my supervisor Dr. Patsy Chau for her
patient guidance and the long way support in my dissertation in these two years. Dr.
Chau’s insightful comments and suggestions enable me to complete this dissertation
successfully. Thank you very much Dr. Chau.
I would also like to thank my classmates for their support in the past two-year of study.
I have had a fruitful time in studying master. Last but not the least, I would like to
thanks my family and my fiance for their continuous encouragement and backup in
my life which making it goes smooth and delighted.
1
Table of Content
Abstract ...........................................................................................I-II
Declaration.......................................................................................IV
Acknowledgments............................................................................V
Table of Content...............................................................................1
Abbreviation.....................................................................................6
Chapter 1 introduction
1.1 Background................................................................................7
1.2 Affirming needs.........................................................................10
1.3 Aim............................................................................................12
1.4 Objectives..................................................................................12
1.5 Significance...............................................................................12
Chapter 2 Critical appraisal
2.1 Search and appraisal strategies.................................................14
2.1.1 Identification of studies.........................................................14
2.1.2 Inclusion criteria....................................................................14
2.1.3 Data extraction.......................................................................15
2.1.4 Appraisal strategies................................................................15
2.2 Summary of the data.................................................................16
2.2.1 Search result...........................................................................16
2
2.2.2 Level of evidence...................................................................17
2.2.3 Patients characteristics...........................................................18
2.2.4 Intervention............................................................................19
2.2.5 Control...................................................................................19
2.2.6 Outcome measures.................................................................20
2.3 Summary of results...................................................................20
2.4 Synthesis...................................................................................21
Chapter 3 Translation and application
3.1 Implementation potential.........................................................24
3.2 Transferability of the findings..................................................24
3.2.1 Target setting.........................................................................24
3.2.2 Target audience......................................................................25
3.2.3 Philosophy of care.................................................................26
3.2.4 Periods for implementation and evaluation...........................26
3.3 Feasibility of the innovation.....................................................27
3.3.1 Manpower..............................................................................27
3.3.2 Multi-discipline co-operation................................................28
3.3.3 Tools for evaluation...............................................................28
3.4 Costs and benefits.....................................................................29
3.4.1 Individual benefits and risks..................................................29
3.4.2 Material costs of the institution.............................................31
3
3.5 Establishing evidence based practice guideline.......................32
3.5.1 Evidence based guideline/Protocol development.................32
Chapter 4 Implementation plan
4.1 Identifying of stakeholders......................................................34
4.1.1 Frontline users of the ward...................................................34
4.1.2 Management level of the department...................................35
4.1.3 Administrative level of the hospital.....................................35
4.2 Communication plan...............................................................35
4.2.1 Initiation phase.....................................................................36
4.2.2 Facilitating phase..................................................................37
4.2.3 Sustaining phase...................................................................38
4.3 Pilot study plan........................................................................38
4.3.1 Participants ..........................................................................38
4.3.2 Procedure..............................................................................39
4.4 Evaluation plan........................................................................39
4.4.1 Patient outcome....................................................................40
4.4.2 Health care procedures outcome...........................................40
4.4.3 System outcome....................................................................41
4.5 Nature of patients to be involved.............................................41
4.6 Determining the number of clients..........................................41
4.7 Data analysis............................................................................42
4
4.8 Basis for an effective change of practice...........................................42
Chapter 5 Conclusion...............................................................................44
Appendices
Appendix 1 Search strategies...................................................................45
Appendix 2 Flow diagram of the systematic search................................46
Appendix 3 Tables of evidence................................................................47
Appendix 4 SIGN critical appraisal checklist .........................................52
Appendix 5 VAS for pain level................................................................53
Appendix 6VAS for anxiety level............................................................54
Appendix 7 Set up cost for massage therapy...........................................55
Appendix 8 Estimated currents costs for massage therapy......................56
Appendix 9 Estimated savings for massage therapy................................58
Appendix 10 An evidence based protocol on massage therapy...............59
Appendix 11 Key to evidence statements and
grades of recommendation.......................................................................69
Appendix 12 Estimated schedule for implementation
and evaluation..........................................................................................70
Appendix 13 Labouring women satisfaction survey (English
version).....................................................................................................72
Appendix 14 Labouring women satisfaction survey (Chinese version)...73
Appendix 15 Staff satisfaction survey......................................................74
5
Appendix 16 Staff survey on acceptance of EBP guidelines................75
References.............................................................................................76
6
Abbreviation and Symbols
Abbreviation
APN Advanced Practice Nurse
COS Chief of Service
DOM Department of Manager
EBP Evidence based practice
NO Nursing Officer
VAS Visual Analogue Scale
WM Ward Manager
Symbols
% Percentage
e.g. Example
7
Chapter 1 Introduction
1.1 Background
Childbirth is a unique experience. It contains happiness, stress, fear, pain, fatigue and
negative moods. Among them, pain is an inevitable part of labour as well as the most
irritating part of child birth. Pain level is correlated to the increasing of cervical
dilation and the frequency of the uterine contraction. The stages of labour include
three stages: first, second and third stage. For the first stage of labour, starts with the
regular uterine contractions and cervix becomes shorten until reaches 10-cm (Lowe,
2002). In this stage, the pain is caused by mechanical stretching from the lower
uterine segment, the cervical tissue stretching during dilation and pressure on the
adjacent structures and nerves. During this stage, women usually can tolerate the pain
well and require less pharmacological and non-pharmacological pain relief methods.
For the second stage of labour, the cervix is fully dilated and the baby is born (Lowe,
2002). In this stage, pain comes from the distention of vaginal wall, traction of pelvic
floor and stretching from the perineum muscle. During this stage, women usually
experience more pain and require for stronger pain relief methods. For third stage of
labour, it starts from the baby out to the delivery of the placenta. The pain is caused
by the uterine contractions to separate the placenta from the uterus and squeeze the
placenta out of the vagina. At this stage, women do not require for any pain relief
methods. When the labour progresses to advanced stage and causes increasing
intensity of labour pain, women become more and more anxious and fear. As a result,
emotion is involved and a negative birth experience is brought out (Ip, W. Y. 2000).
Bertsch et al. (1990) reported that a negative birth experience was brought out when
husbands talked and touched less to the laboring women during labour. The labour
companions especially husbands voted by the laboring women as the increasing the
8
meaning of labour experience, since the labour companions accompany with the
labouring women for their whole labour process. Thus the labour companions were
closely related to the birth experience of laboring women (Ip, W. Y. 2000).
On the other hand, Mohta, Sethi, Tygi and Mohta (2003) stated that psychological
aspect is as important as the physical care. Evidence based on nursing care shows that
the psychological aspect of patient care is important (Cooke et al., 2005). Anxiety is a
co-existing factor with labour pain when women in their labour, Anxiety can be
defined as the subjective emotions of people experiencing an unfavorable situation
and it would cause physical changes like elevate blood pressure and palpitation (Alan,
2000). Therefore, anxiety of laboring women not only affects their physical but also
psychological status such as psychological satisfaction. Besides, anxiety also
interferes with the duration of labour and induces a longer duration of labour pain
(Gallo et al., 2013).
Hence, there are various pain relief methods which include pharmacological and
non-pharmacological for relieving labour pain in different stages of labour. The
pharmacological pain relief methods include injection of medication such as Pethidine,
inhalation of Entonox, administration of spinal analgesia and so on. However, these
various pharmacological pain relief methods not only bring many side effects on
women but also on newborns. After injection of Pethidine, majority of women
complain they are suffering from nausea, vomiting, dizziness and so on. Furthermore,
if they give birth within four hours after injection of Pethidine, the newborns are at
high risk of neonatal respiratory depression (McCaffery & Beebe, 1989; Mobily, et al.,
1994). So, the non-pharmacological pain relief methods such as breathing exercise,
9
birth ball, music therapy, massage therapy and so on become more and more popular
in labour pain relief.
According to different stages of labour, there are various non-pharmacological pain
relief methods could be used. During the latent phase of first stage of labour, women
can walk or move freely and experience less pain, therefore, breathing exercise and
birth ball could be used for pain relief (Royal College of Midwives, 2002). When the
labour progresses into more advanced stage of labour, women experience more severe
labour pain, at that time, they cannot control their breathing easily or they cannot
move easily from the birth ball exercises. Therefore, massage become more common
in relieve labour pain in active phase of labour. Massage not only could be
administered by different persons such as midwives or labour companions but also
could be administered to laboring women when they are in different position such as
supine position or side lying position (Field et al., 1999).
Massage is an ancient technique which widely performed during labour to reduce
labour pain in western countries such as Australia (Keenan, 2000). Midwives in the
western countries point out that massage can decrease the severity of pain, relieving
muscle spasm and promoting general relaxation (Brown et al., 2001). There has been
comprehensively and marked decrease in women in labour pain for many years has
been demonstrated (Gallo et al., 2013). Mechanisms of massage can work through
two different pathways: either blocking the pain impulse by the A-fibers transfer or
stimulating the locally released endorphin (Chang et al., 2002). In addition, massage
provides physical contact with the labour companions, promote relaxation and reduce
stress emotion. Richardoon (1984) stated that appropriate contact can help to relieve
10
pain and maintain a sense of body boundary intactness. Furthermore, the potential
benefits of massage include decreasing the intensity of pain, relieving muscle spasm
and decreasing anxiety. Massage administered by labour companions could influence
laboring women reaction to pain, made them feel safer and calmer (Brown, 2001).
1.2 Affirming needs
In obstetric wards in Hong Kong, the usual pain relief methods for relieving labour
pain are mainly on pharmacological methods such as inhalation of Entonox and
injection of Pethidine. Although non-pharmacological pain relief methods are also
used by laboring women, massage therapy is new to the laboring women.
The local setting is Ward A of the Obstetric & Gynecological Department (O&G) in a
public hospital in Hong Kong, the trained midwives provide both pharmacological
and non-pharmacological pain relief methods such as breathing exercises, birth ball
and music therapy. There were total 8160 deliveries in year 2013 in Ward A. 85%
women choose injection Pethidine or inhalation of Entonox as their pain relief
methods since these methods have fast acting on relieving pain. Massage as a
non-pharmacological pain relief method. It is available in Ward A but it is only
administered to labouring women by physiotherapists. When the physiotherapists are
occupied, massage cannot be administered.
Meanwhile, due to the heavy workload in ward A, midwives usually focus on the
physical care and specific procedures for women. The psychological aspects such as
anxiety or psychological satisfaction of women are often ignored.
Labour companions present in labour are common in Ward A. Laboring women
11
psychological satisfaction is correlated to the presence of labour companions. Labour
companions can be defined as the people who accompany with women during labour.
They are usually husbands, physiotherapists or registered massage therapists and so
on. Kenian and Hobfall (1989) had pointed out that the presence of labour
companions does not necessarily help laboring women to cope better. However, the
support during labour is useful when the labour companions are able to help the
laboring women to meet their needs during labour such as relieving pain by massage.
In the first stage of labour, the labour companions’ presences give practical support to
the laboring women. The labour companions stay with women longer time, they can
offer more practical help. It is reasonable that the first stage of labour is usually a long
and painful for the laboring women, therefore, they need more practical help and
support at this time. Therefore, during the labour, labour companions not only provide
physical but also psychological care such as support to women. In addition, research
findings reported that support from labour companions during labour is conducive to a
more positive experience of childbirth, shorter duration of labour and a positive
attitude towards growing into motherhood (Beaton & Gupton, 1990; Koeske &
Koeske, 1990; Pascoe & French, 1990). Hence, labour companions would be the best
person to administer massage therapy to the labouring women.
Massage is a good labour pain relief method because it is a non-invasive technique; it
has the least possible side effects for women and newborns, prolonged pain relief
effect, easy to administer and has appropriate sedative without affect the uterine
contractions. In addition, massage administered by labour companions to the laboring
women not only reduce the anxiety level in laboring women but also improved the
psychological support and satisfaction of them. However, there is a lack of evidence
12
among midwives and labouring women on massage therapy in pain relief or reduction
anxiety. Thus, this leads to massage therapy is new to as a pain relief method.
Therefore, massage administered by labour companions to laboring women may
relieve pain or anxiety of the labouring women in the local setting.
1.3 Aim
The aim of this dissertation is to develop an evidence-based guideline of performing
massage by labour companions to labouring women so as to improve labour
outcomes.
1.4 Objectives
1) To review, summarize and synthesis current evidences.
2) To determine the transferability and feasibility of performing massage by labour
companions in local setting and generate a set of guideline for using massage on
labouring women in labour ward.
3) To develop an implementation plan and evaluation plan for the proposed
innovation.
1.5 Significance
This dissertation implies the use of massage administered by labour companions to
either relieving labour pain or anxiety in labouring women. Pharmacological pain
relief methods such injection of Pethidine or Inhalation of Entonox and
non-pharmacological pain relief methods such breathing exercises, birth ball or music
therapy are the main pain relief methods in Hong Kong. While these pain relief
methods can relieve pain, they cannot provide support for the labouring women
13
during the labour process. In contrast, massage therapy not only provide pain relief
but also provide psychological support for the labouring women, let them would not
feel alone during their labour. However, massage as a pain relief method but it is new
to midwives. Moreover, nursing intervention puts too much emphasis on
pharmacological relief methods. Therefore, massage as an alternative method to
relieve labour would be investigated. The massage therapy not only relieve labour
pain without any side effects but also provide relaxation to women during labour, as a
result, the anxiety level is reduced. Meanwhile, since the labour companions
administered massage therapy to the labour women, their satisfaction is increased. So,
massage therapy is worth to utilizing as a pain relief for labouring women.
14
Chapter 2 Critical appraisal
2.1 Search and appraisal strategies
2.1.1 Identification of Studies
A systematic approach was used to identify relevant research studies. The three
databases used were PubMed, CINAHL plus and PsycINFO. There were four groups
of keywords included. The first group was the intervention includes ‘massage’ or
‘massage therapy’ or ‘birth massage’. The second group was ‘labour obstetric’ or
‘parturition’. The third group was ‘labour pain’ or ‘labor pain’. The fourth group was
‘anxiety’ or ‘anxious’ or ‘stress’. The search operator ‘AND’ was used between
groups in order to identify reference including at least on instance from each of the
three groups of keywords or concepts. However, since the labour pain and anxiety
were the two outcome measures, therefore, the search operator ‘OR’ was used to
connect them. Each database was used to screen search results. Hence, relevant
references were collected and duplicated results were combined. In order to extract
more journal articles, a further manual search of the reference lists of the initially
identified studies was done.
2.1.2 Inclusion criteria
The inclusion criteria were:
Randomized Controlled Trial (RCT)s or Clinical Controlled Trials;
Massage was done by labour companions in labouring women started at the first
or second stage of labour
The massage therapy was done by labour companions in the first stage of labour
because at this stage, women do not start delivery yet. In this stage, labour
companions can provide the appropriate massage to the target subjects according to
15
the labour pain. It is not feasible to perform massage for women after delivery, as the
clients need a rest or receive other treatments.
The exclusion criteria were:
Women who have medical, obstetric or psychiatric complications;
Women have cesarean section;
Women do not have labour companions.
2.1.3 Data extraction
The search was performed on 5th August, 2014. The first screened were the title and
abstracts of the resulting citations. If the articles match the selection criteria, full text
of papers and their references lists would be reviewed.
The table of evidence is constructed according to the Scottish Intercollegiate
Guidelines Network (SIGN) (2012). The table of evidence included: bibliographic
citation, study design, characteristics of subjects, intervention, comparison and effect
size.
2.1.4 Appraisal strategies
An appraisal tool named Scottish Intercollegiate Guideline Networks (SIGN)
developed by the National Health Service (NHS) was used to assess the quality of the
selected articles. Studies were evaluated with regard to the following criteria which
including ‘appropriateness and clarify of the focus question’, ‘randomization method’,
‘concealment method’, ‘blinding’, ‘similarity at the start of the trial’, ‘different
between groups is the treatment under investigation’, ‘standard measure’, ‘dropout
rate’, ‘intention to treat’, and ‘carried and compared at different sites’.
16
2.2 Summary of the data
2.2.1 Search result
After reviewed all the related papers, five papers (Chang et al., 2002; Karami et al.,
2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) were selected as
the evidence. Search details and flow diagram of the systematic search are listed in
Appendix 1 and 2. Data from five papers were extracted to a table of
evidenceAppendix3. These five studies were carried out at Taiwan (Chang et al.,
2002), Tehran (Karami et al., 2007; Mortazavi et al., 2012), Canada (Janssen et al.,
2012) and Brazil (Gallo et al., 2013). All these studies were conducted in labour ward
(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012, Janssen et al., 2012;
Gallo et al., 2013). Three were randomized controlled trial studies (Chang et al., 2002;
Janssen et al., 2012; Gallo et al., 2013) and two were clinical controlled trial studies
(Karami et al., 2007; Mortazavi et al., 2012). For the randomized controlled trials
studies, Chang et al. (2002) used four balls for the randomization. Two balls were
marked E for the experimental group and the other two balls were marked C for the
control group. Janssen et al. (2012) used a random seed generated the sequential
number for the experimental and control group. Gallo et al. (2013) used a computer
-generated random allocation list to randomly assigned experimental or control group.
Both Karami et al. (2007) and Mortazavi et al. (2012) were clinical controlled trials so
they did not have randomization.
In these five studies, the sample size ranged from 46 to 120. Three studies power
calculation for their sample size (Chang et al., 2002; Janssen et al., 2012; Gallo et al.,
2013). Although these three studies used power calculation, the sample size relatively
small (Chang et al., 2002; Janssen et al., 2012; Gallo et al., 2013). Two studies did not
17
mention power calculation for their sample size (Karami et al., 2007; Mortazavi et al.,
2012).
All selected articles showed statistically significant results for the intervention (Chang
et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et
al., 2013).
2.2.2 Level of evidence
The quality assessments of five studies were detailed illustrated in Appendix 4. Three
studies were rated ‘++’ because of high quality (Chang et al., 2002; Janssen et al.,
2012; Gallo et al., 2013). One study was rated ‘+’ because of medium quality
(Mortazavi et al., 2012). The remaining study was rated ‘-’ because of low quality
(Karami et al., 2007).
Five studies were addressed research question clearly and appropriately (Chang et al.,
2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al.,
2013). Three studies clearly illustrated the randomization method and approved
ethically (Chang et al., 2002; Janssen et al., 2012; Gallo et al., 2013). The two
remaining studies did not mention the randomization method (Karami et al., 2007;
Mortazavi et al., 2012). The blinding process only addressed in threes studies (Chang
et al., 2002; Janssen et al., 2012; Gallo et al., 2013). The remaining two studies did
not mention the blinding process (Karami et al., 2007; Mortazavi et al., 2012). The
treatment and control groups are similar at the start of the trial in five studies (Chang
et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et
al., 2013). Demographic data and characteristic of both groups were provided in five
studies (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al.,
18
2012; Gallo et al., 2013). In five studies, p-value was determined by the statistical
testing showed that there was no significant difference in demographic characteristics
between intervention and control group (Chang et al., 2002; Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
All subjects in the same group were treated equally in five studies. Outcomes
measured in a standard, valid and reliable way in five studies. Dropout rate was well
or adequately covered in five studies and the dropout rate was 2% (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
Three studies were well applied the ‘intention to treat’ analysis (Chang et al., 2002;
Janssen et al., 2012; Gallo et al., 2013). Two studies were not addressed the ‘intention
to treat’ issue (Karami et al., 2007; Mortazavi et al., 2012). Five studies were carried
out in one site only, carried and compared in different sites were not applicable in
these five studies.
2.2.3 Patient characteristics
Age range of the laboring women was from 16 to 36 years. All studies were women
have their first pregnancy with singleton (Chang et al., 2002; Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The five studies had
the same inclusion criteria including they were randomized controlled trial or
controlled trial studies, participants, subjects have labour companions. Subjects had
medical, obstetrical or psychiatric history were excluded from these studies.
19
2.2.4 Intervention
Three studies performed massage by labour companions to laboring women started
from cervical dilation 3 to 4 cm (Chang et al., 2002; Mortazavi et al., 2012; Janssen et
al., 2012), one study performed massage by labour companions at the cervical dilation
4 to 5cm (Gallo et al., 2013) and one study performed massage by labour companions
at the cervical dilation 8cm (Karami et al., 2007). The duration of massage performed
varied from 30 minutes to five hours. Subjects from four studies were administered
massage by labour companions for 30 minutes at the first stage of labour (Chang et al.,
2002; Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013). Subjects from
one study performed massage by labour companions up to five hours (Janssen, et al.,
2012). There were different of labour companions to administer massage to the
laboring women. Subjects from four studies were administered massage by husband
(Chang et al., 2002; Mortazavi et al., 2012), a registered massage therapist (Janssen et
al., 2012) and physiotherapists (Gallo et al., 2013). One study did not mention the
massage performed by whom (Karami et al., 2007). Three studies stated that various
parts of body could be administered massage included hands, forearms, shoulders,
waist, sacrum and buttock (Chang et al., 2002; Karami et al., 2007; Mortazavi et al.,
2012). The parts of body which administered massage depended on women
preference. One study mentioned that the massage mainly administered at between
T10 and S4 which nerves corresponded to the paravertebral ganglia, delivery canal
and perineum (Gallo et al., 2013). The remaining one study did not mention the
location of massage (Janssen et al., 2012).
2.2.5 Control
Five studies treated control group in usual care according to the labour ward routine
20
care.
2.2.6 Outcome measures
The primary outcome measure was the change in pain severity at the end of the
intervention period. The secondary outcome measure was the change in anxiety level
and the personal satisfaction at the end of the intervention period. All studies clearly
defined the time frame of measuring the severity of pain (Chang et al., 2002; Karami
et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). On the
other hand, there were different measuring tools used to measure the pain severity.
Chang et al. (2002) and Mortazavi et al. (2012) stated that the labour pain was
measured by the self-reported present pain intensity (PPI) Scale. Two studies used the
visual analogue scale (VAS) as a measuring tool to measure the labour pain (Karami
et al., 2007; Gallo et al., 2013). Janssen et al. (2012) used the Short Form McGill pain
Questionnaire to measure the labour pain. For the anxiety level, two studies used the
visual analogue scale to measure the anxiety (Chang et al., 2002; Mortazavi et al.,
2012). However, the remaining three studies did not measure the anxiety level
(Karami et al., 2007; Janssen et al., 2012; Gallo et al., 2013). For the measuring
personal satisfaction level, the questionnaires were disturbed to laboring women in
one study (Chang et al., 2002). The remaining of studies did not clearly mention the
measuring of laboring women in their psychological satisfaction (Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al.,2012; Gallo et al ., 2013).
2.3 Summary of results
Five studies reported that the labour pain in labouring women was significantly
reduced in the intervention group (Chang et al., 2002; Karami et al., 2007; Mortazavi
21
et al., 2012; Janssen et al., 2012; Gallo et al., 2013). Moreover, all studies showed that
the severity of pain significantly decreased when massage administered to laboring
women in latent and active phase of labour (Chang et al., 2002; Karami et al., 2007;
Mortazavi et al.,2012; Janssen et al., 2012; Gallo et al., 2013). For the anxiety level,
two studies mentioned that anxiety was significantly reduced in the laboring women
when they were administered massage by labour companions in latent and active
phase (Chang et al., 2002; Mortazavi et al., 2012). Moreover, the psychological
satisfaction of laboring women were higher after the massage administered (Chang et
al., 2002; Mortazavi et al., 2007). There was no complications of massage reported
from these studies (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012;
Janssen et al., 2012; Gallo et al., 2013).
2.4 Synthesis
Massage as an effective intervention to reduce the pain in laboring women has been
explored in different countries. Five studies focused on massage intervention in labour
ward. In five studies, the population range of age is 16 to 36 years which is applicable
for women in obstetric settings. All these five studies reported that the labour pain in
laboring women had significant reduction, meanwhile, the anxiety level in laboring
women also reduced. Therefore, these results could be generalized to the primiparous
women with singleton, no medical, obstetric or psychiatric complications and they are
in active labour.
In massage intervention used in these studies, there were different types of massage
such as Swedish massage. Three studies used Swedish massage (Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al., 2012). Swedish massages were included
22
shoulder and back massage, abdominal effleurage and sacral pressure. The remaining
two studies did not mention the type of massage used (Chang et al., 2002; Gallo et al.,
2013). In addition, different parts of body could be administered massage such as
hands, forearms, waist, sacrum, buttocks or feet. The most common parts used to
administer massage were sacrum and buttocks in all studies (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
The less common parts used to administer massage were hands, forearms and feet
(Janssen et al., 2012; Gallo et al., 2013). Five studies stated that both the types of
massage and locations of body to be administered massage depended on women
preferences (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et
al., 2012; Gallo et al., 2013). Furthermore, there is no standardization for whom to be
the labour companions to administer massage. The labour companions could be
husbands, registered massage therapists or physiotherapists (Chang et al., 2002;
Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). Hence, administered
massage for the women with comfortable position is needed to be considered.
The ideal duration of massage in most studies reported was 30 minutes due to the
prolonged performing massage would cause the fatigueless of the labour companions
(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013).
One remaining study stated that massage administered by labour companions could be
up to five hours during labour (Janssen et al., 2012). On the other hand, the duration
of massage could be adjusted with labouring women preferences (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
The ideal time to start performing massage to reduce labour pain is when the cervical
dilation to 3-4 cm suggested by the studies (Chang et al., 2002; Mortazavi et al., 2012;
23
Gallo et al., 2013). Massage group had statistically significant lower pain state
compared with control group in first stage of labour (Chang et al., 2002; Karami et al.,
2007; Mortazavi et al., 2012, Janssen et al., 2012; Gallo et al., 2013). The massage
can provide sooth effect and leads women feel relaxed when they are in their latent. If
the massage started at more advanced stage of labour, the increased severity of labour
pain would adversely affect their anxiety level (Chang et al., 2002; Karami et al.,
2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) .
In conclusion, a positive effect of massage administered to laboring women during
their active labour may not only could minimize their labour pain but also reduce their
anxiety, provide psychological support and increase their psychological satisfaction.
Although pain could not be totally eliminated, massage promotes the comfort and
psychologically support. The labour companions physical touch not only influence the
laboring women reaction to pain, but also make them feel safer and calmer. The most
important is to improve laboring women well-being during labour. Moreover, the
presences of labour companions serve encouragement, security and psychological
assurance for the laboring women, let the labouring women would not feel alone
during the labour process. As a result, laboring women could have a positive
experience of labour. Furthermore, there is no harmful or adverse effect in women or
neonatal. Thus, massage is safe and can be applied to laboring women.
24
Chapter 3 Translation and application
3.1 Implementation potential
After reviewing the five selected studies from chapter 2, it has been shown that
applying massage therapy to labouring women by labour companions is efficacious in
reduce pain or anxiety during labour. It is worth to consider translating the
corresponding evidence and applying it in Ward A. Before developing evidence-based
practice (EBP) guideline and implementing massage therapy to reduce labour pain or
anxiety in Ward A, there should be a thorough assessment of its implementation
potential. Transferability of findings, the feasibility of implementation and the cost/
benefit ratio of the intervention would be assessed (Polit & Beck, 2004).
3.2 Transferability of the findings
Transferability refers to how the proposed innovation fits and suits into the Ward A.
To assess the suitability of the massage therapy protocol in Ward A, the
demo-graphical characteristics of target population, philosophy of care and the
program flow between Ward A and the reviewed studies must be compared.
3.2.1 Target setting
Our target setting is Ward A in a public hospital in Hong Kong which provides
obstetric service and has to take care of numerous pregnant women every day.
According to the hospital statistics, the total number of deliveries in Ward A in 2013
was 8160. That means there are 680 deliveries in Ward A each month. There are three
sections in Ward A. The first section consists of two cubicles which can hold twelve
beds for pregnant women undergo obstetrician assessments, vaginal examination,
induction or augmentation of labour women who have their first stage of labour and
25
other procedures. The pharmacological and non-pharmacological pain relief methods
will be provided in these cubicles for women who have their first stage of labour
(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012;
Gallo et al., 2013). The second section is an isolation room for women who have
infectious diseases such as tuberculosis and high fever cases. The third section is
delivery rooms which provide eight delivery beds for the labouring women to deliver
at the same time, meanwhile, non-pharmacological pain relief methods will also be
provided for women during their second stage of labour. The time for providing
pharmacological and non-pharmacological pain relief methods is similar with the
literatures (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et
al., 2012; Gallo et al., 2013).
3.2.2 Target audience
Basically, the characteristic of the patients were similar for both local and those
mentioned in the literatures in the first stage of labour (Chang et al., 2002; Karami et
al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The age
ranges of women in Ward A are from 16 to 42 and included primiparous and
multiparous, 90% of primiparous women are aged at 16 to 36 in Ward A. The age
ranged from 16 to 36 and are primiparous in the selected papers (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
Thus, the demographic characteristics of women in the Ward A should be similar to
those considered in the literatures. Around 82% of primiparous women with labour
companions will be benefit from the massage therapy each month. Hence, massage
therapy administered by labour companions should be considered to relieve pain or
anxiety in labouring women in Ward A.
26
3.2.3 Philosophy of care
Pain is inevitable physical feeling during labour. Pain is one of the most concerns in
the Ward A but the busy work load and heavy patient-load shorten the
midwife-to-client time available for communication and choose the most suitable pain
relief for the labouring women to relieve their pain. The health care professionals’
primary focuses mainly on task-centered. Inadequate management of pain may affect
nursing quality of care and may increase the use of pharmacological pain relief which
will increase the fatal adverse effects on both maternal and neonatal outcomes
(Mortazavi et al., 2012; Gallo et al., 2013). According to the Code of Professional
Conduct and Code of Ethics from the Nursing Council of Hong Kong (2002),
midwives should provide a therapeutic environment and promote the less pain for the
laboring women. Midwives not only provide the best-possible services but also
wholehearted patient-centered care (“HA Code of Conduct”, 2009). In view of this,
the new program introduced is compatible to the philosophy of massage therapy in the
local setting which focus on relieve pain (Chang et al., 2002; Karami et al., 2007;
Janssen et al., 2012; Gallo et al., 2013) or anxiety (Chang et al., 2002; Mortazavi et al.,
2012) and promote a positive relationship between the laboring women and the labour
companions (Chang et al., 2002). Moreover, the massage therapy administered by
labour companions can help to reduce the vulnerabilities caused by pharmacological
pain relief methods to labouring women (Gallo et al., 2013).
3.2.4 Periods for implementation and evaluation
For this new program, the implementation and evaluation will be about 72 weeks.
Initial phase, including guideline and proposal development, seeking approval,
Formation of committee and organizing discussion groups will take 20 weeks. The
27
facilitating phase, including purchasing of the massage oil and organizing training
sessions for midwives, will take 12 weeks. In the sustaining phase, a pilot program
will be executed for 24 hours over four weeks, as the most committee members work
in different shifts. The women pain level or anxiety level, the acceptance and the
preference of massage therapy will be evaluated and analyzed in another 12 weeks.
Finally, an evaluation will take six months for data collection, analysis and evaluation.
Women will fill the evaluation forms for massage therapy in their postnatal. Midwives
would also fill a survey to evaluate the effectiveness of the intervention.
3.3 Feasibility of the innovation
3.3.1 Manpower
There are total 42 midwives in the Ward A and only ten of them have the
qualifications to perform massage therapy for the labouring women. The lack of
qualified trained midwives may affect the service quality provided for pain or anxiety
management. However, most of the untrained midwives are willing to commit
changes such as having training on massage therapy and studying evidence based
practice and providing better management in pain and anxiety. Suppose there will be
total three one-hour training sessions in three consecutive weeks, all midwives can be
trained within three weeks. In addition, a training session can be offered to new staff
annually.
Attitudes of the midwives are crucial for implementing an innovative program
(Alanen et al., 2009). Firstly, the Departmental Manager (DOM) and Ward Manager
(WM) advocate the midwives to use electronic database in intranet to update their
midwives knowledge. Meanwhile, the majority of midwives in Ward A recognize that
28
the pharmacological pain relief methods for labouring women is not good and higher
chance for the labouring women to suffer from respiratory and cardiovascular
complications such as drowsiness, lower blood pressure and neonatal complications
such as neonatal respiratory distress. These complications delay the labour process
and increase the time for resuscitation and workload for the midwives to close
monitor the labouring women. Therefore, midwives in Ward A are willing to explore
changes to improve this situation (Alanen, Valimaki & Kaila, 2009). Although there
might be slightly increase in workload for the midwives who undergo massage
therapy training, a probability of promotion will serve as an incentive for midwives to
participate.
3.3.2 Multi-discipline co-operations
Alanen (2009) stated that a good co-operation between midwives and other
disciplines such as physiotherapists or labour companions is a crucial factor for
implementing a new program successfully. In usual practice, only trained midwives
and physiotherapists to perform massage therapy for the labouring women in their
convenient time. But now, some of the physiotherapists are forming a group for
massage therapy. They are only ones who are responsible for administering massage
therapy to the labouring women. The DOM and the Ward Manager will hold a
meeting with the physiotherapists to discuss the issue including the advantages of
implementing this new programme and improve the communication between
midwives and physiotherapists. Midwives workload is likely increased because they
need to guide the labour companions to administer massage therapy to the labouring
women. Thus, the support from labour companions is also important. According to
Keinan & Hobfall (1989), lack of support from labour companions may increase
29
labour pain or anxiety in labouring women. Therefore, the labour companions, who
are usually the labouring women’s husband or relatives, are pleased to administer
massage therapy to the labouring women in order to provide some practical help
during labour (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen
et al., 2012; Gallo et al., 2013).
3.3.3 Tools for evaluation
As mentioned in the reviewed literatures, Visual Analogue Scale (VAS) was used for
labouring women to rate their pain and anxiety level (Chang et al., 2002; Karami et al.,
2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The VAS record
charts for pain and anxiety are readily available in the Ward A. Details are shown in
Appendix 5 and 6.
3.4 Costs and Benefits
3.4.1 Individual benefits and risks
In Ward A, there are about 680 delivery cases each month, with 584 primiparous
delivery cases. According to the hospital statistics, with around 80% primiparous
labouring women with labour companions and around 82% primiparous cases with
labour companions are willing to provide massage therapy to the labouring women,
approximately around 383 cases are likely to benefit from participating in massage
therapy each month. The main benefits for implementing the new program are the
decrease their pain or anxiety during labour (Chang et al., 2002; Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
Moreover, massage therapy as a non-pharmacological pain relief method can reduce
85% use of pharmacological pain relief methods and reduce 80% the risks of having
30
respiratory and cardiovascular complications for women and babies (Janssen et al.,
2012; Mortazavi et al., 2013).
It is relatively low risks for labouring women to receive this new program since the
massage therapy administered by trained labour companions would not cause any
harm (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al.,
2012; Gallo et al., 2013). Therefore, this new program is safe for labouring women.
For the midwives, the instruction of administration of massage therapy is mainly the
source of increased workload for them. Midwives need to spend five minutes for
instructing the labour companions to perform massage. During labour, midwives
mainly focus on monitoring progress of labour. Nevertheless, job satisfaction of
midwives can be gained from the new program because labouring women are more
willing to establish a good rapport with them. However, the experienced trained
midwives will use extra time to hold the antenatal classes, their workload might be
slightly increased. They might be feeling stressed but a probability of promotion will
serve as an incentive for these midwives to participate.
For the obstetricians, less labouring women require pharmacological pain relief
methods such as Pethidine injection or spinal anesthesia to relieve labour pain after
the implementation of new program (Janssen et al., 2012; Gallo et al., 2013).
Labouring women are more willing to use massage therapy as a pain relief method
and thus reduce the chance of having complications from pharmacological pain relief
methods (Janssen et al., 2012; Gallo et al., 2013). Therefore, obstetricians are willing
to support the labouring women to use massage therapy to relieve pain and anxiety.
31
For the physiotherapists, some of them are forming a group which only responsible
for the midwife training sessions and administering massages therapy to labouring
women. The labour companions can share 90% workload for them. Therefore, they
are also willing to use massage therapy on labouring women to relieve pain and
anxiety.
3.4.2 Material costs of the institution
The total set up costs of massage program includes staff training, the salary of a
physiotherapist as a demonstrator and photocopies. A physiotherapist will be invited
three hours for training the midwives, the salary is $375 and 32 midwives using total
32 hours to attend the training sessions. The total cost of staff training will be $6000
and the photocopies will be $25.2. The total set up costs will be $6400.2. Details are
shown in Appendix 7. The recurrent costs of massage program include staff for data
collection and analysis, the midwives as the instructors and trainers who will do the
training in the antenatal classes and training session for new staff. The salary of staff
for data collection and analysis will be $7500 monthly. New staff training will be
$375 monthly. The antenatal classes will be $4500 monthly. The total recurrent costs
will be $18818.9 monthly.
The total set up costs and recurrent cost in the first year for massage program will be
approximately $232227(=$6400.2+ $18818.9 ×12).
Meanwhile, after implementation of this new program, according to the selected
literatures, 30% of labouring women use less 85% pharmacological pain relief
methods in their labour (Janssen et al., 2012; Gallo et al., 2013). That means in 383
32
eligible cases, 115 cases will use less 1 cylinder of Entonox which costs $600 for one
case. Thus, the cost in pharmacological pain relief methods is reduced $69000
monthly. Moreover, according to the reviewed literatures, about 30% of eligible cases
shorten duration of labour after receiving massage therapy (Karami et al., 2007;
Mortazavi et al., 2012). In addition, for the 383 eligible cases, physiotherapists can
save 30 minutes to administer massage in one case. The total man-power saved due to
administer massage to the labouring women among physiotherapists is 11490 minutes
monthly, of which the salary saving is about $23937.5. Details are shown in Appendix
9.
After calculating the above costs and benefits, the material benefits for implementing
this new program are $1115250(=$92937.5×12) in one year. The saving in the first
year already exceeds the set up cost plus the recurrent cost. Details are shown in
Appendix 9.
3.5 Establishing evidence based practice guideline
The proposed massage therapy administered by labour companions for labouring
women is transferable and feasible in the Ward A. It is also safe and cost-effective. An
evidence based practice (EBP) guideline will be developed to serve as guidance for
implementing the new intervention.
3.5.1 Evidence based guideline/ Protocol development
The Scottish Intercollegiate Guidelines Network (SIGN) (SIGN, 2012) was used to
develop the guideline (Appendix 11). Eleven recommendations were developed, all
were graded A which means a body of evidence in the selected studies can directly
33
applicable to the target population and demonstrating overall consistency of results.
Details of the protocol are shown in Appendix10.
34
Chapter 4 Implementation plan
The transferability and implementation potential of the innovation are discussed
previously. After developing the evidence-based guidelines, it is time to apply
massage intervention into practice. The next step would be a deliberate consideration
on the overall implementation plan. This could be accomplished through deciding the
communication plan, pilot testing and evaluation plan. The schedule of
implementation and evaluation is shown in Appendix 12 and will be discussed as
follows.
4.1 Identifying the stakeholders
The proposed innovation will be affected by the stakeholders. Ingersoll (2005)
claimed that identification of stakeholders is important as effective communication
can build up a positive cooperative relationship and gain their support throughout the
proposed program. Three levels of key stakeholders in this program including the
frontline users of the ward, management level of the department and administrative
level of the hospital.
4.1.1 Frontline users of the ward
The proposed protocol users were 42 midwives in the labour ward. Midwives can
make the decision of starting massage according to their professional judgments. They
are required to assist the labouring women in relieving labour pain or anxiety and
instruct labour companions to perform massage to labouring women. As midwives are
the users of the protocol, effective communication and detailed explanation of the
protocol to them is essential.
35
4.1.2 Management level of the department
Stakeholders in this group are the Chief of Service (COS), Department Operation
Manager (DOM) of the Obstetrics and Gynecology department, four Ward managers
(WM), five Nursing Officers (NO) and ten Advanced Practiced Nurses (APN). They
are experts in making clinical development and planning. Thus, seeking their approval
and support for the implementation of the new clinical guideline is essential. Besides,
positive staffs outcome and team spirit can be enhanced by the support from the
leader in a clinical environment (Ingersoll, 2005).
4.1.3 Administrative level of the hospital
Stakeholders in this group are the hospital Chief Executive Officer (CEO) and
General Manager of Nursing (GMN). They are the policy marker of the hospital, so
they have to be informed and agree for the implementation of a new protocol. Besides,
it will be easier to apply for funding from the hospital if a cost-effective guideline is
presented to them.
4.2 Communication plan
Ingersoll (2005) claimed that effective communication with stakeholders is the
cornerstone of a successful new clinical guideline. Better collaboration of different
parties can be facilitated by effective communication. Hence, the implementation of
the program will be smooth and easier and less conflict will be aroused from
misunderstanding. Hence, the communication plan will be divided into three phases
including initiation, guidance and sustaining.
36
4.2.1 Initiation phase
The initial phase are to identify the staffs concerns about the massage which is
beneficial to labouring women and increases awareness of the proposed treatment in
clinical. The estimated duration of initiation phase is about 20 weeks which including
4 weeks used for guideline and proposal development, 14 weeks used to get the
proposal and budget approval from COS, DOM, and WMs and sending budget plan
and makes grant from the daily expense pool in Ward A for the innovation; one week
is used for formation of an innovation committee, one week is used to convince the
staff to support this innovation. The details are as follows.
The communication proposal and budget plan will be prepared by the proposer in this
phase. The second step is sharing the innovation idea and seeking approval for
funding from the Obstetric Departmental Consultative Committee held by COS,
DOM and WMs monthly. A presentation which focuses on the need and the people
responsible for the innovation, the content of guidelines, the duration of pilot study
and the budget requirements will be made to the COS, DOM and WMs by the
proposer.
After getting the approval, a committee will be formed. The committee includes one
WM act as a leader to promote the innovation; one APN act as a supervisor to
organize the process and 6 senior midwives act as trainers to train other midwives and
act as instructors to labour companions. The proposal and the guideline will be
presented by the WM at the staff meeting held by DOM and WMs monthly. The
midwives will be convinced by the WM to support the innovation by presenting the
current situation and the needs of labour women. The staff will be explained about the
proposal with the massage intervention evidence-based practice (EBP) guidelines,
working flow chart and budget plan. The time spent for the implementation and little
37
impact on workload will be emphasized by the proposer. During the meeting, the
proposer may be required to address concerns and suggestions raised by the midwives
in order to refine the innovation.
Besides, six senior midwives will be identified by the proposer and they will
responsible for instructing other midwives and to execute the innovation. They are the
committee members and have training in massage before and have qualification to
train other midwives. Three one-hour group discussions will be organized and led by
them. Each group includes 10 to 15 midwives. The effectiveness of current
interventions in reducing labour pain will be discussed. Besides, some midwives who
are against this innovation will be convicted so that all midwives will support this
innovation.
The obstetricians, physiotherapists and allied health workers will not directly take part
in this innovation but they also need to be informed by the committee team during the
ward meetings and the flow in recruiting eligible women will also be informed so that
preventing interruption during the intervention.
4.2.2 Facilitating phase
The estimated duration of facilitating phase is about twelve weeks including six senior
midwives in the committee team will be responsible to purchase suitable massage oil
for the massage and act as the trainer to train other midwives.
The midwives training will take place for three weeks. Three identical training
sessions will be provided to midwives who work in different shifts. It is essential to
train the midwives become the trainers to the labour companions in order to enhance
their theoretical knowledge, understand the EBP guidelines and skills practice. In
order to ensure all staff understanding of the innovation, the innovation description
38
and a flow chart will be sent via internal e-mail. The updated progress will also be
sent to midwives to facilitate communication. To keep the EBP guideline up-to-date
and review of the massage intervention annually is needed.
4.2.3 Sustaining phase
The committee focuses on monitoring the midwives acceptance and satisfaction with
the EBP guideline in the sustaining phase. Therefore, a pilot testing will be executed
and discussed. The estimated duration is about 16 weeks including 4 weeks for the
data collection and 12 weeks for the data analysis.
4.3 Pilot study plan
Pilot study is a small-scale pre-study before the implementation of the innovation.
Due to there is no similar guideline before, a trial is essential to perform in order to
ensure the feasibility and evaluate the logistics of the program. Hence, the
administrators will be given confidence to implement the full-scale afterwards. The
objectives of this pilot study are to test the feasibility and acceptability of the program
and assess staff compliance towards the protocol.
4.3.1 Participants
The participants are the eligible women in the labour ward who fulfilled the inclusion
and exclusion criteria. The inclusion criteria includes primiparous women who age
ranged from 16 to 36, have a singleton, with labour companions who attended
antenatal class before and presence during labour, no obstetric, medical complications
or cognitive disability and no infection disease. The exclusion criteria includes
women have spinal injuries and have bone deformity.
39
4.3.2 Procedure
In order to let all the midwives on both AM, PM and night shift experience the
proposed intervention, the implementation will run for 24 hours a day for 4 weeks.
Each of the 42 midwives would have hands-on experience with at least three cases.
Therefore, a total of 126 pilot cases will be recruited.
Triage assessment and recruitment will begin at the labour ward. After recruitment,
informed consent will be signed. According to the guidelines, labour companions will
start 30 minutes massage to the labouring women at the first stage of labour. Each
woman will complete the assessment form of labour pain and anxiety level
(Appendix 5 and 6) after the 30-minute massage and a satisfaction survey with
Chinese and English version respectively (Appendix 13 and 14) will be used to
evaluate their overall satisfaction with their experience of the massage on postnatal
day 1.
Data input and analysis will be carried out in 12 weeks, including eight weeks will be
used to refine the proposed EBP guideline according to the results of the pilot test in
order to tailor-made to the clinical situation.
4.4 Evaluation plan
A detailed plan should be prepared to evaluate the effectiveness of the implementation.
The evaluation takes 24 weeks which includes evaluation of three types of outcomes,
including the pain, anxiety and satisfaction in labouring women, the satisfaction and
acceptance of new guideline of health care providers and the cost of system as
follows.
40
4.4.1 Patient outcome
The primary outcome is pain level of labouring women after massage. The Visual
Analogue Scale (VAS) is used to measure the pain level (Appendix 5). The VAS form
will be given to labouring women after the massage which starts at their cervical
dilation 3 to 4 cm (Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) so
as to assess the pain level after receiving 30 minutes massage.
The secondary outcomes are the labouring women anxiety and satisfaction levels. The
VAS form (Appendix 6) will be given to labouring women after the massage which
starts at their cervical dilation 3 to 4cm (Mortazavi et al., 2012; Janssen et al., 2012;
Gallo et al., 2013) to assess the anxiety level. They are also asked their satisfaction
during labour by filling a questionnaire on the postnatal day 1. Seven questions are
included in the questionnaire. The women overall satisfaction with massage will be
rated from 1, totally unsatisfied to 5, totally satisfied. If more than four questions
rated for 3 to 5 in the form, that means they are satisfied with the intervention. The
survey will be illustrated in Appendix 13 and 14 respectively.
4.4.2 Health care providers outcome
The health care providers outcome is the job satisfaction and the acceptance of EBP
guidelines of the midwives. This is to evaluate the midwives satisfaction of the
innovation. The staff satisfaction survey (appendix15) and the acceptance survey
(appendix 16) will be used to assess staff satisfaction and acceptance of the EBP
guidelines. Seven questions are included in the questionnaires. The overall
satisfaction and acceptance surveys will be rated from 1, totally unsatisfied to 5,
totally satisfied. If there are above 4 questions rated for 3 to 5 in the forms, that means
41
the staff are satisfied and accept of the EBP guidelines. The questionnaires will be
done at the end of the evaluation period. Afterwards, the committee members will
collect and analyze the questionnaires.
4.4.3 System outcome
The system outcome is the reduction in cost of pharmacological pain relief methods.
The use of pharmacological pain relief methods in the labour ward is reduced
meanwhile the expenditure on the pharmacological pain relief methods will also be
saved in the labour ward. This can be measured by the in-hospital expenditure on the
pharmacological pain relief methods during the three-month evaluation period
compared with last year’s data in the same period.
4.5 Nature of patients to be involved
The participants are the eligible women in the labour ward who fulfilled the inclusion
and exclusion criteria. The inclusion criteria of the participants include primiparous
women who age ranged from 16 to 36, have a singleton, with labour companions
presence during labour, no obstetric, medical complications or cognitive disability and
no infection disease. The exclusion criteria includes women have spinal injuries and
have bone deformity.
4.6 Determining the number of clients
According to Lenth’s (2011) sample size calculator, one-sided sample t-test is used to
estimate the number of sample in order to test for the mean pain scores for a single
group. Polit and Beck (2004) recommended the level of significance is 0.05 and the
power is taken as 80%. The mean VAS score for pain level reduction by 0.5 compared
to those who did not receive massage or more will be regarded as effective. From the
42
reviewed studies, only Karami et al. (2007) provided the standard error (1.02) of VAS
score. The dropout rate is 2% in the reviewed studies (Chang et al., 2002; Karami et
al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The sample
size should be 29. So, one month will be enough to recruit the planned sample size.
4.7 Data analysis
The Statistical Package for Social Science (SPSS) version 19 will be used to analyze
the collected data. A significance level of 0.05 will be used. For patient outcomes, the
objective is to compare if the mean values of pain and anxiety are lower than those of
the usual care. One-tailed t-test will be used to compare mean values of pain and
anxiety after implementation of intervention respectively against their corresponding
values in the usual care. A one-tailed z-test will be used to test if the proportion of
labouring women rated satisfaction (rated 3 or above in 4 or more questions) of the
EBP guidelines are higher than 60%. For health care provider outcomes, the objective
is to test if the proportion of staff rated satisfaction and acceptance (rated 3 or above
in 4 or more questions) of the EBP guidelines are higher than 60%. A one-tailed z-test
will be used. For the system outcome, the objective is to compare the cost of the
pharmacological pain relief method. The cost of the pharmacological pain relief
method will be calculated and compare with the value before the implementation.
4.8 Basis for an effective change of practice
The reduced pain and anxiety level of labouring in their labour by using 30 minutes
massage will be the foremost important indication of an effective change of practice.
From the reviewed studies, taking the conservative estimation, mean VAS score for
pain level reduction by 0.5 compared to those who did not receive massage or more
43
will be regarded as effective. The mean VAS score for anxiety level reduction by 0.5
or more will be regarded as effective. When 60% of women feel satisfied with
massage in the survey, the satisfaction will be regarded as increased.
The midwives will act as the user level of the innovation. The results are considered
to be positive if the midwives report 3 to 5 in 4 or above questions in the staff
satisfaction and acceptance surveys. When 60% of the midwives report positive in the
surveys, the EBP guideline will be considered acceptable and satisfactory.
Besides, the costs of pharmacological pain relief methods are considered to be
reduced if 30% reductions in using pharmacological pain relief methods (Janssen et
al., 2012).
44
Chapter 5 Conclusion
In view of the prevalence of labour pain, more women will use pharmacological pain
relief methods to relieve pain. Based on the findings of the reviewed literature, a
massage administered by labour companions for labour women not only can relieve
labour pain but also reduce anxiety and increase their satisfaction of labour process. It
is believed that labour women will reduce use of pharmacological pain relief methods
when this evidence-based program is adopted. A well implementation planning and
other considerations such as environment, manpower and cost are the foundation so
that this program can be implemented successfully. Besides, a good communication
plan among different parties is also the major determining issue in the entire program.
From the reviewed literature, the massage program is implemented to labour women
with labour companions, its benefits over the pharmacological pain relief methods in
labour women which is well supported by the reviewed literature ( Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
With advance of massage technique, massage will soon become the most common
non-pharmacological pain relief method to labouring women. Therefore, this massage
program should be reviewed and advanced if the massage becomes the main stream of
non-pharmacological pain relief approach.
45
Appendix 1 Search Strategies
Search Items Electronic databases
Pubmed CINAHL
Plus
PsycINFO
Search Date 5/8/2014 5/8/2014 5/8/2014
(1)massage OR massage therapy OR
birth massage
60090 86759 26862
(2)labour obstetric OR parturition 148659 126862 109867
(3)labour pain OR labor pain 138052 148734 12867
(4)anxiety Or anxious OR stress 167926 189672 186796
(1)AND(2) AND ((3)OR (4)) 267 385 309
Limit to RCT OR clinical controlled trial
And Year And full text
150 76 84
Eliminate irrelevant studies after
screening title and abstract
76 23 24
Eliminate duplication with other
databases
34 12 9
Eliminate irrelevant studies after
reviewing full text
5 0 0
Manual search of the reference lists of
selected articles (no addition)
5 0 0
Total 5 0 0
46
Appendix 2 Flow Diagram of the Systematic Search
Records identified
through database
searching
(n= 310)
Additional records
identified through
other sources
(n= 0)
Records after screening title and abstract
(n=123)
Records after duplicate
removed
(n=55)
Full-text articles
assessed for
eligibility
(n=55)
Studies included in
qualitative synthesis
(n=5)
Records excluded
(n= 187)
Full-text articles
excluded
(n=50)
Intervention was not
administered by
labour companions
(n=36)
Intervention was not
started at the first
stage of labour
(n=4)
Outcome measures
were not related to
labour pain or anxiety
(n=10)
47
Appendix 3 Table of Evidence
Bibliographic
Citation,
Study type &
Evidence
level
Patient
Characteristics
Intervention Comparison Outcome measures Effect size
Gallo et
al.,2013
Randomized
Controlled
Trial
++
--Aged 16 to 36
--primigravida
--a singleton
--cephalic
presentation
--equal or more
than 37 weeks of gestation
--spontaneous
onset of labour
--cervical dilation
4-5cm with
appropriate
uterine
contraction
--no use of
pharmacological
pain relief --no medical
problems
--intact
membrane
--literacy
Received a
30-min massage
by a
physiotherapist
during active
phase of labour
(i.e.cervical dilation at 3-4
cm)
(n=23)
Received
routine care
(n=23)
Intensity ,
characteristics,
location of pain and
the time of use
pharmacological
pain relief methods
were assessed after 30 minutes massage
administered in
active phase of
labour
1) The pain intensity
was measured by
visual analogue scale
(0-100mm)
2) The
characteristics of
pain were assessed
by the short-Form
McGill Pain
Questionnaire the
words chosen to
describe the pain
were such as
cramping, arching or
tearing
3)The location of
pain was recorded by using a standard
body diagram
4)The time of use
pharmacological
pain relief methods
1) The pain
intensity
Massage –control:
-20(95%CI -10to
-31)
2)No significant
difference in the
characteristics of
pain in two groups
3)The location of pain were the same
in suprapubic and
lumbar region in
two groups
4)The time of use
pharmacological
pain relief methods
Massage-control:
0.7 (95%CI -0.1
to1.5)
48
Bibliographic Citation,
Study type &
Evidence
level
Patient characteristics
Intervention Comparison Outcome measures Effect size
Mortazavi et
al., 2012
Clinical
controlled
trial
+
--Age between
16 and 36
--normal
pregnancy
without any
complications
--gestation age
between 37 and 42 weeks
--cervical
dilatation less
or equal to
4cm
A 30-min
massage done
by labour
companions at
cervical dilation
at 3-4 cm and in
3 phases of
labour (n=40)
Labour
companions
present in 3
phases of
labour
(n=40)
Received
routine care
(n=40)
The length of active
phase in labour, the
intensity of pain, the
level of anxiety and
satisfaction were
assessed after 30
minutes of massage
in 3phases of labour.
1)The length of
active phase in
labour
2)The intensity of
pain was measured
by a numeric analog
scale of self -reported
present pain intensity
(PPI) scale as
follows: 0, no pain;1,mild pain;2,
moderate pain; 3,
distress; 4, severe
pain and 5,
intolerable pain
3)The level of
anxiety was measures
with the standard
visual analog
scale(VAS) which consists 10-cm
horizontal line define
no anxiety at the left
and worst anxiety at
the right
4)Satisfaction with
labour
companionsperforme
d massage was
measured by the
standard visual analog scale (VAS)
which consists of 1
10-cm horizontal
line , the high values
showed increase in
the level of
satisfaction
1)Mean active phase
length:
Massage group :
2.6h(SD=0.95h)
Attendant group:
5.7 h(SD=1.89h)
Control group:
7.5h( SD=1.87h) The massage had a
shorter duration of
active phase in
labour (p<0.001)
2) Massage group
had significantly
lowest pain level
among three groups
in the 3 phases of 1st
stage of labour : 7.83
(p<0.005)
3)Massage group
had significantly
lowest level of
anxiety among 3
groups in 3 phases
of 1st stage of
labour : 6.5
(p<0.005)
4)Satisfaction level
was significantly
higher in massage group in 3 phases of
1st stage of labour :
7.65 (p<0.001)
49
Bibliographic
Citation ,
Study type &
Evidence level
Patient
Characteristics
Intervention
Comparison
Outcome measures
Effect size
Janssen et al.,
2012
Randomized
controlled trial
++
--Null parity
--Singleton
--Cephalic
presentation
--37-41 weeks
of gestation
--Age
between18 and
35
--Spontaneous
onset of labour
--Ability to speak and read
English
Massage started
at 3-4 cm
cervical dilation
and administered
up to 5 hours by
a registered
massage therapist
(n=37)
Received
routine care
(n=40)
Cervical dilation at
the time of
administration of
epidural analgesic,
the pain intensity in
3 phases of labour
and the length of
first and second
stage of labour
were assessed after
5 hours of massage
administration. 1)Cervical dilation
at the time of
administration of
epidural analgesic
2)The pain intensity
in 3 phases of
labour was
measured by The
Short form McGill
Pain Questionnaire,
0=none, 1=mild,
2=moderate and
3=severe pain
3)The length of
first and second stage of labour
1)Cervical dilation at
the time of
administration of
epidural analgesic:
Massage group5.9
cm(95% CI 5.2-6.7)
Control group4.9
cm(95%CI 4.2-5.8)
Epidural analgesic was
significant requested
earlier in control group (p<0.005).
2)The pain intensity in 3
phases of labour:
During latent phase:
Massage group=3.7
Control group=6.9
During active phase:
Massage group=5.4
Control group=8.3
During transitional phase:
Massage group=4.4
Control group=7.3
Massage group had
significantly less pain in
3phases of labour
(P<0.005).
3) The length of lst
stage of
labour(min):
Massage group=897.4
Control group=788.6(P
<0.028)
The length of 2nd stage
of labour (min):
Massage group=136
Control group=125 (P <0.036)
There were statistically
significant differences in
the length of labour.
50
Bibliographic Citation,Study
type &
Evidence level
Patient characteristics
Intervention Comparison Outcome measures Effect size
Karami et al.,
2007
Clinical
controlled trial
-
--Primiparous
--Age at25 to
35
--Singleton
--38to 42
weeks of
gestation
Massage stated
at cervical
dilation at 8cm
of first stage of
labour and
administered
for 30 minutes (n=30)
Received
routine care
(n=30)
The severity of
pain and the
duration of 1st and
2nd stage of labour
were assessed after
administration of
massage.
1) The severity of
pain in the first
stage of labour was
measured by visual
analogue scale
(VAS) which is a
10-cm line, the
right and left
extremes of the line
were noted as pain free and the most
severe pain.
2) The duration of
1st and 2nd stage of
labour
1)The severity of pain
in the first stage of
labour
Mean of labour pain
scores:
Massage group: 7.22
(SD=0.83) Control
group:7.84(SD=1.02)
Massage group had a
significantly less pain in
the first stage of labour
(P<0.004).
2)The duration of 1st
stage of labour:
Massage
group=264.16mins Control
group=362.5min
Massage group has
significantly shorter
duration of 1st stage of
labour (P<0.001).
The duration of 2nd
stage of labour:
Massage
group=37.16min
Control group=30.50 min
Nosignificant difference
in two groups
In the 2nd stage of
labour (p=0.157).
51
Bibliographic
Citation,
Study type &
Evidence
level
Patient
characteristics
Intervention Comparison Outcome measures Effect size
Chang et
al.,2002
Randomized
controlled
trial
++
--aged 18 to 36
--between 37and
42 weeks of
gestation
--labour
companions
presented during
labour
--estimated
cervical dilatation less or equal
to4cm
A 30-min
massage
started at
cervical
dilation at
3-4 cm and
performed by
labour
companions
at 3 phases of 1st stage of
labour
(n=30)
A routine care
and 30-min of
researcher’s
attendance
with
conversation
at 3 phases of
1st stage of
labour
(n=30)
The intensity of
pain, the anxiety
level, satisfaction
of laboring women
and satisfaction of
labour companions
were assessed after
administered 30
minutes of
massage.
1)The intensity of
pain at 3 phases of
1st stage of labour
was measured by
the self –reported
present
intensity(PPI)
scale, a measure of
the overall
intensity on a scale of 0-5: 0 represents
no pain;1,mild; 2
discomforting;
3,distressing; 4
horrible;
5excruciating pain.
2) The anxiety
level at 3 phases of
1st stage of labour
was measures by
the visual analogue
scale which
consists of 1 10-cm
horizontal line with
the descriptors ‘no
anxiety’ at the left
and ‘worst possible
anxiety’ at the
right.
3) Satisfaction of
support from
partners
4)Satisfaction of
partners being as
labour companions
1)The intensity of
pain at 3 phases of 1st
stage of labour:
Massage-control
Latent phase
-0.57 (p=0.000)
Active phase
-0.43 (p=0.002)
Transitional phase
-0.70 (p=0.00) Significantly lower
PPI scores in the
massage group at 3
phases of 1st stage of
labour.
2)The anxiety level at
3 phases of 1st stage
of labour:
Massage –control
Latent phase -16.27
(p=0.040) Active phase -8.93
(p=0.0144)
Transitional
phase-4.50
(p=0.0355)Statically
significant of lower
anxiety in massage
group in 3 phases of
1st stage of labour
3)Satisfaction of
support from partners d=0.57, (95% CI of
d=0.09-1.04 ,
p=0.019)
Significantly increase
in satisfaction of
support from
labouring women.
4)Satisfaction of
support from partner
being as labour
companions: d=0.70, 95% CI of
d=0.30-1.10, p=0.001). Significantly
increase in
satisfaction of partners being as
labour companions.
52
Appendix 4 SIGN-critical appraisal checklist
Gallo et al
2013
Janssen et al
2012
Mortazavi et al
2012
Karami et al
2007
Chang et al
2002
Appropriate &
clearly focused
question
Well
covered
Well
covered
Well covered Well
covered
Well
covered
Randomization
method
Well
covered
Well
covered
Not applicable Not
applicable
Well
covered
Concealment
method
Well
covered
Well
covered
Not applicable Not
applicable
Well
covered
Blinding Well
covered
Adequately
addressed
Not applicable Not
applicable
Adequately
addressed
Similar at the
start of the trial
Well
covered
Well
covered
Adequately
covered
Adequately
covered
Well
Covered
Only
difference
between
groups is the
treatment
under
investigation
Well
covered
Well
covered
Well
covered
Well
covered
Well
covered
Standard
measurement
Well
covered
Well
covered
Adequately
addressed
Adequately
addressed
Well
covered
Dropout rate Well
covered
(2%)
Well
Covered
(2%)
Adequately
addressed
(2%)
Adequately
Addressed
(2%)
Well
covered
(2%)
Intention to
treat
Adequately
addressed
Adequately
addressed
Poorly
addressed
Not
addressed
Adequately
addressed
Carried and
compare at
different sites
Not
applicable
Not
applicable
Not applicable Not
applicable
Not
applicable
Rating ++ ++ + --
(Due to the
small
sample
size )
++
53
Appendix 5 VAS for pain level
INSTRUCTIONS:
The level of pain is described in a 10-cm linear line from the left to the right. The left
is ‘0’ (the least pain) and the right is ‘10’ ( the most pain ). Choose a number below
that indicates how you feel the pain right now, that is, at this moment. There is no
right or wrong answer.
0 1 2 3 4 5 6 7 8 9 10
Source:
VAS: Kahl, C., & Cleland, J. A. (2005). Visual analogue scale, numeric pain rating
scale and the McGill pain questionnaire: An overview of psychometric properties.
Physical Therapy Reviews, 10, 123-128.
Please stick patient’s gum
label here
Official use:
At the cervical dilation at 3 to 4cm
Cubicle □ Delivery room □
Massage therapy
Given □ N/A □
54
Appendix 6 VAS for anxiety level
Official use:
INSTRUCTION
The level of anxiety is described in a 10-cm linear line from the left to the right. From
the left ‘0’ indicates no anxiety, from the right ‘10’ indicates the most anxiety. Choose
and circle a number which indicates how anxiety you fell right now.
0 1 2 3 4 5 6 7 8 9 10
Source:
VAS: Kahl, C., & Cleland, J. A. (2005). Visual analogue scale, numeric pain rating
scale and the McGill pain questionnaire: An overview of psychometric properties.
Physical Therapy Reviews, 10, 123-128.
Please stick patient’s gum label
here
Official use:
At the cervical dilation at 3 to 4 cm
Cubicle □ Delivery room □
Massage therapy
Given □ N/A □
55
Appendix 7 Set up cost for massage therapy
Expense Quantity Amount (HKD)
Training sessions for
midwives
32 midwives in Ward A
1 hour per midwife in
training session
Estimated mean salary of
a midwife $33000
Hourly salary:
$33000 ÷ 44( hours
/week) ÷4
(week/month)= $187.5
32 hours
$6000
The salary of a
physiotherapist as a
demonstrator in 3 hours
demonstration
1 physiotherapist as a
demonstrator in 3 hours
demonstration
Estimated mean salary of
a physiotherapist
$22000
Hourly salary:
$22000 ÷ 44
(hours/week) ÷ 4
(week/ month) = $125
3 hours
$375
Photocopies
Instruction sheet ( 1 for
each midwife)
Survey (for midwives)
$0.3 X 42
$0.3X 42
$25.2
Total setup cost
$ 6400.2
56
Appendix 8 Estimated recurrent costs for massage therapy
Recurrent cost per month
Expense Quantity Amount(HKD)
Photocopies
Survey ( For client) ( $0.6 per set)
VAS form for labour pain level
( $0.3 )
VAS form for anxiety level ($0.3)
383 sets
383 sets
383 sets
$459.6
Stationary
Pen
Readily
available
Computer
For data input and analysis
Readily
available
Manpower
Supervisor for data collection, input
and analysis
5-day work , 8 hours per day
Hourly salary
$33000 ÷ 44( hours /week) ÷4
(week/month)= $187.5
40 hours
$7500
Manpower
Midwives for instructing the labour
attendances to perform massage
5 minutes instruction for each case
383 cases per month
Hourly salary
$33000 ÷ 44( hours /week) ÷4
(week/month)= $187.5
31.9 hours
$5984.3
57
Appendix8 (Continue)
Recurrent cost per month
Training session for new staff per month
1 new midwife in Ward A
1 hour for the midwife in training
session
Hourly salary:
$33000 ÷ 44 (hours/week) ÷4
(week/month) =$187.5
The trained senior midwife as the trainer
1 hour for the training
Hourly salary:
$33000 ÷ 44 (hours/week) ÷4
(week/month) =$187.5
1 hour
1 hour
$ 375
Training sessions for labour attendants per
month
4 training sessions in 1 month
2-hour training session in each
antenatal class
3 midwives in each antenatal class
Hourly salary
$33000 ÷ 44( hours /week) ÷4
(week/month)= $187.5
4 x 2 x3
$4500
Total recurrent cost
$ 18818.9
58
Appendix 9 Estimated savings for massage therapy
Monthly delivery cases in Ward A
680
Around 86% women who are primiparous
584
Around 82% primiparous women with labour companions
willing to perform massage therapy
(Assuming physiotherapists are not available for massage)
383
Around 30% primiparous women decrease to use
pharmacological pain relief methods
115
115 Primiparous women with massage therapy reduce 1
cylinder of Entonox usage
115(primiparous women with massage therapy) x $600 (1
cylinder of Entonox)
$69000
383 (primiparous women with massage therapy) × 30 min per
case
The total man-power saved to administer massage to
labouring women among physiotherapists is 11490 minutes
monthly
Hourly salary :
$22000 ÷ 44 (hours/ week )÷ 4( weeks /month)= $125
Salary saved for shortening of labouring time
(11490÷ 60) × $125
$23937.5
Estimated benefit for massage therapy per month:
$(69000 + 23937.5)
$92937.5
59
Appendix 10
An evidence based protocol on massage therapy
administered by labour companions to labouring women Date released: January 2015
Version: Version 1
Protocol prepared by: Tse Lai Fan, Registered Midwife and Nurse
1. Background
Pain in labour is inevitable. As the labour proceeds to advance stages, the labour pain
and anxiety also increased (Chang et al., 2002). Pharmacological and
non-pharmacological pain relief methods are provided to labouring women.
Pharmacological pain relief methods such as injection of Pethidine or inhalation of
Entonox not only cause adverse effects on maternal such as drowsiness and low blood
pressure, but also on neonatal such as respiratory depression (Mccaffery & Beebe,
1989; Mobily, et al., 1994). Therefore, the non-pharmacological pain relief methods
such as breathing exercises, birth ball, music therapy and massage therapy become
more common in labour pain relief.
Anxiety is a co-existing factor with labour pain when women in their labour.
Anxiety would cause physical changes like elevated blood pressure and palpitation
(Alan, 2000). Therefore, anxiety of labouring women is not only affect their physical
but also psychological status such as psychological satisfaction. Besides, anxiety also
interferes with the duration of labour and induces a longer duration of labour pain
(Alan, 2000).
60
Labouring women psychological satisfaction is correlated to the presence of labour
companions. The labour companions support during labour is useful when the labour
companions are able to help the labouring women to meet their needs during labour
such as relieving labour pain or anxiety (Kenian & Hobfall, 1989).
Therefore, massage therapy as a non-pharmacological pain relief method provided by
labour companions not only relieve pain or anxiety but also increases psychological
satisfaction of labouring women and a positive relationship between labouring women
and labour companions would be promoted (Chang et al., 2002). Besides, massage
therapy showed no adverse effects on both maternal and neonatal (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).
Massage therapy is a set of specialized hand movements with different sequences to
provide a soothing pressure on skin of different parts of body (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). It
has been shown to be safe and effective in reducing labour pain or anxiety in
laboruing women (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012;
Janssen et al.m, 2012; Gallo et al., 2013).
2. Objectives
The protocol aims at providing evidence based-guidance for midwives on the
management pain or anxiety in labouring women using massage therapy administered
by labour companions in the obstetric ward of a local hospital in order to:
i. Select appropriate women with labour companions to receive massage therapy,
61
ii. Standardize the management of labouring women with massage therapy
administered by labour companions,
iii. Serve as a quick reference for the use of massage therapy in labouring women
3. Target population
Primiparous labouring women administered massage therapy by labour companions
during their labour.
Inclusion criteria:
Aged 18 to 36
Women have a singleton
Women have labour companions who attended in antenatal class and present
during labour
No obstetric or medical complications
No Cognitive disability
No infection disease such as tuberculosis
Exclusion criteria:
Women have spinal injuries
Women have bone deformity such as scoliosis, kyphosis
62
4. Keys to level of evidence and grade of recommendation
In this evidence-based practice protocol on massage therapy administered by labour
companions to labouring women during labour, the system developed by the Scottish
Intercollegiate Guidelines Network (SIGN) (SIGN, 2012) was used to indicate the
level of evidence and grade of recommendation (Appendix 11) of each evidence
based recommendation.
5. Evidence- based recommendations
5.1 Recommendation 1
Primiparous women who have singleton and at gestation weeks 35 to 37 should attend
the antenatal class with at least 2 hours massage therapy training with their labour
companions. (Grade of recommendation: A)
Evidence:
The antenatal class provides massage therapy training under the midwives supervision
can let the labour companions and women are more familiar with massage therapy
and they can practice by their own after the training (Chang et al., 2002; Karami et al.,
2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). (1++, 1-, 1+,
1++, 1++)
5.2 Recommendation 2
Trained midwives can teach labour companions to perform massage therapy. (Grade
of recommendation: A)
Evidence:
Trained midwives have qualifications to teach the labour companions to perform
massage therapy (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012).
63
(1++, 1-, 1+)
5.3 Recommendation 3
The general condition of labouring women and their fetal condition will be assessed
before providing the massage therapy. (Grade of recommendation: A)
i. Women shall be assessed by an obstetrician to exclude any evidence of
maternal or fetal complications.
ii. Midwives shall confirm that the labouring women fulfill all the
eligibility criteria.
Evidence:
In order to ensure the safety of labouring and fetus, the five reviewed literatures
suggested that midwives should assess the maternal and fetal condition before the
labour companions applying massage therapy (Chang et al., 2002; Karami et al., 2007;
Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). (1++, 1-, 1+, 1++,
1++)
5.4 Recommendation 4
The labouring women should have labour companions such as husbands and relatives
to perform massage to them. If no labour companions present in the labour,
physiotherapists or registered massage therapist can perform massage therapy to them.
(Grade of recommendation: A)
Evidence:
Mostly labouring women have husbands to perform massage therapy to them during
labour. (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012). (1++, 1-,
1+) If husbands are not presented in the labour, relative followed by physiotherapists
64
(Gallo et al., 2013) (1++) or registered massage therapists (Janssen et al., 2012) (1++)
can perform massage therapy to the labouring women. All five reviewed studies
suggested that labouring women have labour companions not only provide
psychological support but also can perform massage therapy to relieve their pain and
anxiety. The pain and anxiety level of labouring women were significantly reduced
after receiving massage therapy (Chang et al., 2002; Karami et al., 2007; Mortazavi et
al., 2012; Janssen et al., 2012; Gallo et al., 2013). ( 1++, 1-, 1+, 1++, 1++)
5.5 Recommendation 5
The labouring women can self-select different types of massage (e.g. Swedish
massage). (Grade of recommendation: A)
Evidence:
There are different types of massage (e.g. Swedish massage ) could be administered to
women in order to relieve their labour pain or anxiety (Karami et al., 2007; Mortazavi
et al., 2012; Janssen et al., 2012). (1-,1++, 1++ )
5.6 Recommendation 6
The labouring women can self-select different massage positions (e.g. supine, side
lying or prone position). (Grade of recommendation: A)
Evidence:
The labouring women are able to self -select massage position (e.g. supine, side lying
or prone position) to promote their comfort which show significant pain and anxiety
reduction (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et
al., 2012; Gallo et al., 2013). (1++, 1-, 1+, 1++, 1++)
65
5.7 Recommendation 7
There are different points of body can be administered massage therapy (e.g. hands,
shoulders, lower back or buttock). (Grade of recommendation: A)
Evidence:
There are different points of body can be administered massage therapy such as hands,
shoulders, lower back (Chang et al., 2002; Mortazavi et al., 2012) (1++, 1+) or
buttock (Janssen et al., 2012) (1++) which show significant pain reduction.
5.8 Recommendation 8
Duration of massage therapy should be 30 minutes. (Grade of recommendation: A)
Evidence:
There was the common duration of massage therapy described in four reviewed
literatures which showed significant reduction in labour pain (Chang et al., 2002;
Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013). (1++, 1-, 1+, 1++)
5.9 Recommendation 9
Massage therapy should be started to administer at cervical dilation at 3 to 4 cm at the
first or second stage of labour. (Grade of recommendation: A)
Evidence:
Massage therapy started to administer by labour companions during cervical dilation
at 3 to 4 cm at the first stage of labour or at the second stage of labour can
significantly reduce labour pain or anxiety of target labouring women in their labour
(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012;
Gallo et al., 2013). (1++, 1-, 1+, 1++, 1++)
66
The length of first or second stage of labouring women is also shorten after receving
massage therapy (Karami et al., 2007; Mortazavi et al., 2012). ( 1-, 1+)
6 Recommendation 10
The Visual Analogue Scale (VAS) is used to measure the labouring women pain level
in the Ward A after the massage therapy. (Grade of recommendation: A)
Evidence:
Three out of five relevant studies performed VAS as the measuring tool in evaluating
the pain level. These studies demonstrated a significant decrease in pain level after the
massage therapy (Chang et al., 2002; Karami et al., 2007; Gallo et al., 2013). (1++, 1
-,1++)
6.1 Recommendation 11
The Visual Analogue Scale (VAS) is used to measure the labouring women anxiety
level in the Ward A after the massage therapy. (Grade of recommendation: A)
Evidence:
Two out of five relevant studies performed VAS as the measuring tool in evaluating
the anxiety level. These two studies demonstrated a significant decrease in anxiety
level after the labour companions administered massage therapy (Chang et al., 2002;
Mortazavi et al., 2012). (1++, 1+)
7 References
Alan, E. (2002). Encyclopedia of Psychology: 8 Volume Set. America: American
Psychology Association and Oxford University Press.
67
Chang, M., Wang, S., & Chen, C. (2002). Effects of massage on pain and anxiety
during labour: a randomized controlled trial in Taiwan. Journal of advanced Nursing,
38 (1), 68-73.
Gallo, R. B., Santana, L.S., Ferreira, C. H., Marcolin, A. C., PoliNeto, O. B., Duarte,
D., & Guintana, S. M. (2013). Massage reduced severity of pain during labour: a
randomized trial. Journal of Physiotherapy, 59, 109-116.
Janssen, P., Shroff, F., & Jaspar, P. (2012). Massage therapy and labour outcomes: a
randomized controlled trial. International Journal of Therapeutic and Bodywork, 5(4),
15-20.
Karami N. K., Safarzedeh, A., & Fathizadeh, N. (2007). Effect of massage therapy on
severity of pain and outcomes of labour in primipara. Iranian Journal of Nursing and
Midwifery Research, 12(1), 6-9.
Keinan, G., & Hobfall, S. E. (1989). Distress, dependency, and social support: who
benefits from father’s presence in delivery. Journal of Social and Clinical Psychology,
8, 32-44.
McCaffery, M., & Beebe, A. (1989). Pain: Clinical Manual for Nursing Practice. St
Louis: Mosby.
Mobily, P. R., Herr, H. A., & Nicholson, A. C. (1984). Validation of cutaneous
stimulation intervention for pain management. International Journal of Nursing
68
Studies, 31, 533-544.
Mortazavi, S. H., Khaki, S., Moradi, R., Heidari, K., & Rahimparvar, S. F. (2012).
Effect of massage therapy and presence of attendant on pain, anxiety and satisfaction
during labour. Maternal-Fetal Medicine, 286, 19-23.
69
Appendix 11
Key to evidence statements and grades of recommendation (SIGN 2012)
Levels of evidence
1++ High quality meta-analysis, systematic reviews of RCTs, or RCTs with a
very low risk of bias
1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low
risk of bias
1- Meta analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of
confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal
2- Case control or cohort studies with a high risk of confounding or bias and
a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case report, case series
4 Expert opinion
Grades of recommendation
A At least one meta -analysis, systematic review, or RCT rated as 1++, and
directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly
applicable to the target population, and demonstrating overall consistency
of results
B A body of evidence including studies rated as 2++, directly applicable to
the target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the
target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level3or4; or
Extrapolated evidence from studies rated as 2+
70
Appendix 12
Estimated schedule for implementation and evaluation
Phase Description Duration
Initiation phase Guideline and proposal development
Proposal and budget approval
Send proposal for COS , DOM and WM
for approval
Send budget plan and make grant from
the daily expense pool in Ward A for the
innovation
4 weeks
14 weeks
Formation of the committee
1 WM : as a leader to promote the
innovation
1 APN: as a supervisor for organize the
process
6 senior midwives: as trainer to train
other midwives and as instructors to
labour companions
1 week
Three One-hour group discussions
Organized and led by 6 senior midwives
Discuss the effectiveness of current
intervention
Convict all midwives support the
innovation
1 week
Facilitating phase Purchase of the massage oil
3 midwives : select and purchase the
suitable massage oil
3 weeks
9 weeks
Training to the Ward A staff
Three 1-hour identical training session
provide for midwives who work in
different shifts
The intervention flow in Ward A
71
Sustaining phase
Pilot study
Implementation of the pilot program
Execute within12 weeks, 24 hours a day
The pain level and anxiety level forms
and satisfaction survey given to the
selected labouring women
Satisfaction survey for Staff
Data input and analysis
Refine the proposed EBP guidelines
4weeks
12 weeks
Evaluation The pain ,anxiety and satisfaction level
in labouring women
The satisfaction and acceptance level of
staff
The system outcome
24 weeks
72
Appendix 13
Labouring women satisfaction survey on massage therapy by labour companions in
Ward A. (English version)
1. Do you like administering massage therapy during labour?
(1= totally disagree, 5= totally agree)
1 □ 2 □ 3 □ 4 □ 5□
2. Do you think the duration of the massage therapy is suitable?
(1= totally disagree, 5= totally agree)
1 □ 2 □ 3 □ 4 □ 5 □
3. Do you satisfy with the massage position?
(1=totally disagree, 5=totally agree)
1 □ 2 □ 3 □ 4 □ 5 □
4. Do you think the massage therapy administered by labour companions can help you
reduce labour pain or anxiety during labour?
(1=totally disagree, 5=totally agree)
1 □ 2 □ 3 □ 4 □ 5 □
5. Do you like the massage therapy as a non-pharmacological pain relief method?
(1=totally dislike, 5=totally like)
1 □ 2 □ 3 □ 4 □ 5 □
6 .Overall, I feel satisfy with the massage therapy?
(1= totally unsatisfied, 5= totally satisfy)
1 □ 2 □ 3 □ 4 □ 5 □
7. Will you choose massage therapy as a non-pharmacological pain relief method in
the future pregnancy?
(1= totally disagree, 5= totally agree)
1 □ 2 □ 3 □ 4 □ 5 □
73
Appendix 14
產房孕婦接受按摩治療滿意程度問卷調查
1. 你喜歡在生產中進行按摩治療?
(1=非常不同意, 5=非常同意)
1□ 2□ 3 □ 4 □ 5 □
2. 你認為按摩治療的時間合適嗎?
(1=非常不同意, 5=非常同意)
1 □ 2 □ 3 □ 4 □ 5 □
3. 你認為按摩治療能夠減低生產前的痛楚嗎?
(1=非常不同意, 5=非常同意)
1 □ 2 □ 3 □ 4 □ 5 □
4. 你喜歡陪產者為你進行的按摩嗎?
(1=非常不同意, 5=非常同意)
1 □ 2 □ 3 □ 4 □ 5 □
5. 你喜歡按摩作為一個止痛方法嗎?
(1=非常不喜歡, 5=非常喜歡)
1 □ 2 □ 3 □ 4 □ 5 □
6. 整體來說,我對按摩治療滿意程度
(1=非常不同意, 5=非常同意)
1 □ 2 □ 3 □ 4 □ 5 □
7. 你將來生產會再選擇按摩治療作為止痛方法嗎?
(1=非常不同意, 5=非常同意)
1 □ 2 □ 3 □ 4 □ 5 □
74
Appendix 15
Staff satisfaction survey on massage therapy which reduces either labour pain or
anxiety of laboring women in Ward A.
(1= totally disagree, 5= totally agree)
1. The objectives includes reduce labour pain and anxiety and increase satisfaction of
labouring women in this innovation are achieved.
1 □ 2 □ 3 □ 4 □ 5 □
2. The duration of the massage therapy is suitable.
1 □ 2 □ 3 □ 4 □ 5 □
3. The extra workload for guiding the labour companions to administer massage
therapy for laboring women is affordable.
1□ 2□ 3□ 4□ 5□
4. I think massage therapy is useful to reduce labour pain of labouring women in
Ward A.
1□ 2□ 3□ 4□ 5□
5. I think massage therapy is useful to reduce anxiety in laboring women in Ward A.
1□ 2□ 3□ 4□ 5□
6. I feel confident in instructing the labour companions to administer massage therapy.
1□ 2□ 3□ 4□ 5□
7. I believe the quality of care will be enhanced by massage therapy.
1□ 2□ 3□ 4□ 5□
75
Appendix 16
Staff survey on acceptance of EBP guidelines in Ward A. (1= totally disagree, 5=
totally agree)
1. The EBP guideline for massage therapy is user friendly.
1 □ 2 □ 3 □ 4 □ 5 □
2. The EBP guideline for massage therapy is easy.
1 □ 2 □ 3 □ 4 □ 5 □
3. The flow of using massage therapy in labouring women is easy to follow.
1 □ 2 □ 3 □ 4 □ 5 □
4. I have confidence in using massage therapy which followed by the EBP guideline.
1 □ 2 □ 3 □ 4 □ 5 □
5. The EBP guideline is useful when instructing the labour companions to perform
massage therapy.
1 □ 2 □ 3 □ 4 □ 5 □
6. The EBP guideline should be promoted in other obstetric wards such as antenatal
ward.
1 □ 2 □ 3 □ 4 □ 5 □
7. Massage therapy should be promoted to other obstetric wards in HK.
1□ 2□ 3□ 4□ 5□
76
References
Alan, E. (2002). Encyclopedia of Psychology: 8 Volume Set. America: American
Psychology Association and Oxford University Press.
Alanen, S., Valimaki, M., Kaila, M., & ECCE study group. (2009). Nurses’ experience
of guideline implementation: a focus group study. Journal of Clinical Nursing, 18,
2613-2621.
Benton, J., & Gupton, A. (1990). Childbirth expectation: a qualitative analysis.
Midwifery, 6,133-139.
Bertsch, T. D., Nagashima, W. L., Dykeman, S., Kennell, J. H., & MaGrath, S. (1990).
Labour support by first-time fathers: direct pbservations with a comparison to
experienced doulas. Journal of Psychomatic Obstetrics and Gynecology, 11, 251-260.
Brown, S. T., Douglas, C., & Plaster Flood, L. (2001). Women’s evaluation of
intrapartum non-pharmacological pain relief methods used during labor. The Journal
of Perinatal Education, 10(3), 1-8.
Chang, M., Wang, S., & Chen, C. ( 2002). Effects of massage on pain and anxiety
during labour: a randomized controlled trial in Taiwan. Journal of advanced Nursing,
38 (1), 68-73.
Code of Professional Conduct and Code of Ethics for Nursing in Hong Kong. (2002).
Retrieved November 28th, 2014, from
77
http://www.nchk.org.hkfilemanager/en-pdf/conduct_eng.pdf
Cooke, M., Chaboger, W., & Schluter, P. (2002). The effect of music on preoperative
anxiety in day surgery. Journal of Advanced Nursing, 52(1), 47-55.
Field, T., Hernandez-Reif, M., Hart, S., Theakston, H., Schanberg, S., & Kuhn, C.
(1999). Pregnant women benefit from massage therapy. Journal of Psychosomatic
Obstetrics and Gynecology, 20, 31-38.
Gallo, R. B., Santana, L.S., Ferreira, C.H., Marcolin, A. C., PoliNeto, O.B., Duarte, D.,
& Guintana, S.M. (2013). Massage reduced severity of pain during labour: a
randomized trial. Journal of Physiotherapy, 59, 109-116.
HA Code of Conduct. (2009). Retrieved November 28th 2014, from http://www.
ha.org hk/haho/ho/hrv3/doc/code of conduct.eng.v2 pdf
Ingersoll, G. L. (2005). Evidence-based practice in nursing & healthcare: a guide to
best practice. Philadelphia: Lippincott Williams & Wilkins.
Ip, W. Y. (2000). Relationships between partner’s support during labour and maternal
outcomes. Journal of Clinical Nursing, 9, 265-272.
Janssen, P., Shroff, F., & Jaspar, P. (2012). Massage therapy and labour outcomes: a
randomized controlled trial. International Journal of Therapeutic and Bodywork, 5(4),
15-20.
78
Kahl, C., & Cleland, J. A. (2005). Visual analogue scale, numeric pain rating scale
and the McGill pain questionnaire: An overview of psychometric properties. Physical
Therapy Reviews, 10, 123-128.
Keinan, G., & Hobfall, S. E. (1989). Dtress, dependency, and social support: who
benefits from father’s presence in delivery. Journal of Social and Clinical Psychology,
8, 32-44.
Karami N. K., Safarzedeh, A., & Fathizadeh, N. (2007). Effect of massage therapy on
severity of pain and outcomes of labour in primipara. Iranian Journal of Nursing and
Midwifery Research, 12(1), 6-9.
Koeske, G. F., & Koeske, R. D. (1990). The buffering effect of social supporton
parental stress. American Journal of Orthopsychiatry, 23,440-451.
Lenth, R.V. (2011). Java Applets for Power and Sample Size. Retrieved 5th May, 2015.
From http:// www.stat.uiowa.edu/~ rlength/Power
Lowe, N. (2002). The nature of labour pain. American Journal of Obstetrics &
Gynecology, 186, 16-24.
McCaffery, M., & Beebe, A. (1989). Pain: Clinical Manual for Nursing Practice. St
Louis: Mosby.
79
Melayk, B., & Fineout, O. E. (2005). Evidence-Based Practice in Nursing
& Healthcare: A Guide to Best Practice. Sydney: Lippincott Williams & Wilkins.
Mobily, P. R., Herr, H. A., & Nicholson, A. C. (1994). Validation of cutaneous
stimulation interventions for pain management. International Journal of Nursing
Studies, 31, 533-544.
Mohta, M., Sethi, A. K., Tyagi, A., & Mohta, A. (2003). Psychological care in trauma
patients. Injury, 34(1), 17-25.
Mortazavi, S. H., Khaki, S., Moradi, R., Heidari, K., & Rahimparvar, S. F. (2012).
Effect of massage therapy and presence of attendant on pain, anxiety and satisfaction
during labour. Maternal-Fetal Medicine, 286, 19-23.
Pascoe, J. M., & French, J. (1980). The reliability and validity of the maternal social
support index for pripmparous mothers: a brief report. Family Medicine, 22, 228-230.
Polit, D. F., & Beck, C. T. (2004). Nursing research: principles and methods (7th ed.).
Philadelphia: Lippincott.
Richardson, P. (1984). The body boundary experience of women in labour: a
framework for care. Maternal Child Nursing Journal, 13(2), 91-101.
Royal College of Midwives. (2002). Vision 2000 into Practice Toolkits. UK: RCM
Publication.
80
SIGN. (2012). Retrieved November, 1st 2014, from http://www.sign.ac.uk/