An Evidence Based Guideline of Using Acupressure …nursing.hku.hk/dissert/uploads/Fok Cheung...

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Abstract of dissertation entitled

An Evidence-Based Guideline of Using Acupressure Wristband

in Relieving Nausea and Vomiting for Pregnant Woman

Subjected to Spinal Anesthesia for a Cesarean Section

Submitted by

Fok Cheung Kei

For the Degree of Master of Nursing in the University of Hong Kong

July 2014

Background

Nausea and vomiting are common complications in pregnant woman subjected to spinal anesthesia for

a cesarean section. The etiology of these nausea and vomiting is multifactorial, including intraoperative

hypotension, increased vagal activities, as well as administration of antiemetic drugs.

Non-pharmacological techniques such as the use of acupressure wristband on pericardium 6 (P6) is

shown to be effective in relieving nausea and vomiting with strong evidence support.

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In Hong Kong, the use of acupressure wristband is not as common as in the Western countries. Nurses

are not familiar to this low cost, useful and simple innovation. Therefore, an evidence-based guideline

of using acupressure wristband in relieving nausea and vomiting for pregnant women subjected to

spinal anesthesia for a cesarean section should be developed in Hong Kong clinical setting.

Purpose

Through the method of translation research, evidences are identified, and all findings are systematically

reviewed and critically appraised. Therefore, a highly transferable, feasible and cost-effective

evidence-based guideline on the use of acupressure wristband on P6 acupoint in relieving nausea and

vomiting for women having cesarean section after spinal anesthesia is developed.

Methods

Four electronic databased published from January 1993 to August 2013 were searched. Six eligible

studies were extracted and described in form of table of evidence achieved from The Scottish

Intercollegiate Guidelines Network (SIGN). The validity of studies is assessed by the Methodology

Checklists (SIGN) to justify the level of evidence of studies.

Conclusion

By the use of acupressure wristband on P6 acupoint, patients can diminish nausea and vomiting and

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achieve a better surgical outcome, nurses can gain the new knowledge on acupressure and increase the

quality of care, and the hospital can reduce the cost of using drugs. Therefore, an evidence-based

guideline of using acupressure wristband in relieving nausea and vomiting for pregnant women

subjected to spinal anesthesia for a cesarean section is effective and essential.

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An Evidence-Based Guideline of Using Acupressure Wristband

in Relieving Nausea and Vomiting for Pregnant Woman

Subjected to Spinal Anesthesia for a Cesarean Section

by

Fok Cheung Kei

BNurs (The University of Hong Kong)

R.N. (Hong Kong)

A dissertation submitted in partial fulfillment of the requirement for

the Degree of Master of Nursing at The University of Hong Kong

July 2014

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Declaration

I declare that this dissertation representations my own work, except where due acknowledgement is

made, and that has not been previous included in a thesis, dissertation or report submitted to this

University or to any other institution for a degree, diploma or other qualifications.

________________________________

FOK, Cheung Kei

July, 2014

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Acknowledgements

I would like to express my wholehearted gratitude to my supervisor, Dr. William Li, who has given me

constant guidance, encouragement and support in order to facilitate me to finish this dissertation.

I would like to thank my family, fellow classmates, and all my friends, who share the happiness and

face the hardship with me in the past two years.

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Table of Contents

Abstract i

Declaration v

Acknowledgement vi

Table of Contents vii

Page

Chapter 1: Introduction

1.1 Background 2

1.2 Affirming the need 4

1.2.1 Local Clinical Issue 5

1.2.2 Current Practice 5

1.2.3 Needs for Improvement 6

1.2.4 Potential Innovation 6

1.3 Objectives and Significance 7

1.3.1 PICO 7

1.3.2 Research Question 7

1.3.3 Research Objectives 8

1.3.4 Significance 8

Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies 10

2.1.1 Identification of Studies 10

2.1.2 Inclusion and Exclusion Criteria 11

2.1.3 Data Extraction 11

2.1.4 Appraisal Strategies 12

2.2 Results 13

2.2.1 Search Results 13

2.2.2 Methodological Issues 14

2.3 Summary of Data 17

2.3.1 Population 17

2.3.2 Number of Participants 17

2.3.3 Patient Characteristics 18

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2.3.4 Intervention 18

2.3.5 Control 19

2.3.6 Length of Follow Up 19

2.3.7 Outcome Measures 20

2.3.8 Effect Size 20

2.4 Synthesis of Data 21

2.4.1 Evidence-Based Recommendations 21

2.4.2 Side Effects 23

Chapter 3: Implementation Potential

3.1 Transferability of the Findings 26

3.1.1 Target Audience 26

3.1.2 Target Setting 27

3.1.3 Philosophy of Care 28

3.1.4 Time for Implementation and Evaluation 28

3.2 Feasibility 29

3.2.1 Autonomy of Nursing Staff 29

3.2.2 Staff Training 29

3.2.3 Organizational and Administrative Support 30

3.2.4 Equipment and Resources 31

3.2.5 Evaluation Tools 31

3.3 Costs-Benefit Ratio of the Innovation 32

3.3.1 Material Costs 32

3.3.2 Non-Material Costs 32

3.3.3 Potential Barriers and Solutions of Innovation 33

3.3.4 Potential Benefits of Innovation 34

Chapter 4: Evidence-Based Practice Guideline

4.1 Title 36

4.2 Aims and Objectives 36

4.3 Target Group 37

4.4 Recommendations 37

Chapter 5: Implementation Plan

5.1 Communication Plan 42

5.1.1 Identification the Stakeholders 42

5.1.2 Initiating the Change 43

5.1.3 Guiding the Change 44

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5.1.4 Sustaining the Change 45

5.2 Pilot Study Plan 45

5.2.1 Timeline for Pilot Study 45

5.2.2 Data Collection 46

5.2.3 Guideline Revision 46

Chapter 6: Evaluation Plan

6.1 Identification of Outcomes 48

6.1.1 Patient Outcome 48

6.1.2 Healthcare Provider Outcome 49

6.1.3 System Outcome 49

6.2 Nature and Number of Clients 49

6.3 Length of Measurement 50

6.4 Data Analysis 51

6.5 Basis for the Effective Guideline 52

Chapter 7: Conclusion 54

Appendices 55

References 77

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List of Appendices

Page

Appendix 1 Acupressure Wristband 55

Appendix 2 P6 Acupoint 56

Appendix 3 Search Strategies and Results 57

Appendix 4 Table of Evidence 61

Appendix 5 Level of Evidence & Grades of Recommendation 65

Appendix 6 Methodology Checklist 66

Appendix 7 Costs-Benefit of Implementation 73

Appendix 8 Use of Acupressure Wristband Guideline 74

Appendix 9 Patient Outcome and Satisfaction Assessment Form 75

Appendix 10 Staff Satisfaction Questionnaire 76

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CHAPTER 1

Introduction

Nausea and vomiting are common symptoms experienced during cesarean section under spinal

anesthesia and can also occur in the postoperative period following caesarean section. They have

multiple etiologies, which include hypotension, vagal hyperactivity, uterotonic agents, motion and

medication. (Balki & Carvalho, 2005) It offers significant challenge to the operating theatre nurse, by

potentially increasing the risk of wound bleeding and accidental associated surgical trauma, so as to

increase the nursing care time and manpower in handling the related complications.

Various pharmalogical treatments and antiemetic drugs are widely used to alleviate the symptoms, but,

all such medications are associated with increased healthcare costs, and even caused potential risks to

mother and the baby via breastfeeding. (Balki & Carvalho, 2005) Therefore, non-pharmacological

intervention in relieving nausea and vomiting should be introduced into operating theatre. Acupressure,

by applying skin pressure at acupoint, is an alternative management of minimizing nausea and

vomiting symptoms for woman having cesarean section.

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1.1 Background

Cesarean section is a commonly performed obstetric surgery. It is a surgical procedure in which a baby

is removed from mother’s womb by a series of incisions in the mother’s abdomen and uterus. In

general, cesarean section is done in cases where normal spontaneous vaginal delivery is considered to

be dangerous to the health of the mother or child. Over the past few decades, with the safety of surgical

and anesthetic skills are improved, there has been widespread in the proportion of births born by

cesarean delivery.

Nausea and vomiting are common side effects in woman having cesarean delivery performed. Nausea

is the sensation of unease and discomfort in the upper stomach and throat. Vomiting is the vigorous

throwing out of the contents of one’s stomach through mouth. These gastrointestinal discomforts can be

related to surgical manipulation of the uterus, abdominal viscera and peritoneum, intraoperative

hypotension and also the spinal anesthesia. (Balki & Carvalho, 2005)

Spinal anesthesia is carried out for the majority of cesarean sections, it is a form of regional anesthesia.

For which, patient is awake, through the injection of spinal anesthesia medications to block the

transmission of impulses nerve signals, so as to eliminate pain during surgery. (Smeltzer & Bare, 2004)

However, the reported incidence of nausea and vomiting during cesarean performed under spinal

anesthesia varies from 50% to 80% when no prophylactic antiemetic drug is given. (Kovac, 2000)

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Antiemetic drugs, such as Ondansetron and Metoclopramide, can be used as the treatment for nausea

and vomiting. Routine use of prophylactic antiemetic in pregnant women is not recommended. The

pharmacological treatment options are expensive and can cause undesirable side effects, sspecially

harm to the breastfeeding women, as the drugs move across maternal plasma to breast milk. (Kovac,

2000) For these reasons, using acupressure wristband in relieving nausea and vomiting can be the

alternative harmless option.

Acupressure is a traditional, non-pharmacological and non-invasive intervention, used for more than

3000 years in China, in relieving nausea and vomiting in many circumstances. In the view of Chinese

medicine, the theory of acupressure is based on the philosophy of balance and unity between the

universe, living beings, and energy flow, through applying skin pressure at particular acupoint. P6

acupoint, also known as Nei Kuan or Nei Guan point, is the most commonly used to achieve the

purpose of antiemetic. While the view of Western medicine, it is based on the belief that pressing skin

pressure on P6 acupoint can generate the release of endogenous endorphins, which resemble the opioid

function in producing analgesia and the sensation of well-being. (Hickman, 2005) Acupressure

wristband is the product in providing the antiemetic effect by pressing on P6 acupoint.

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1.2 Affirming the Need

1.2.1 Local Clinical Issue

The common reasons for emergency cesarean section in public hospital include the failure of progress,

fetal distress, previous cesarean birth, and breech presentation. Moreover, there is increasing pregnant

women request for caesarean sections. In Hong Kong, the cesarean section rate significantly rose from

16.6% to 27.4% between 1987 and 1999, representing a 65% increase over 12 years. (Leung, 2001)

According to the records in my hospital, around 1200 cesarean sections were done in operating theatre

annually in a Hong Kong public hospital. Each operating theatre nurses have to encounter around 100

pregnant women having caesarean section procedure every month.

Having a cesarean section under spinal anesthesia in operating theatre, nurses have to work with the

anesthetists, the surgeons and to pay attention to the pregnant women physical and psychological status

at the same time. In addition, studies stated that the incidence of nausea and vomiting during caesarean

performed under spinal anesthesia can be up to 80% when no prophylactic antiemetic is given. (Kovac,

2000) This can be the burden to operating theatre nurses.

Nausea and vomiting would distress a patient, decrease patient satisfaction, interfere with the

intraoperative surgical procedure, deteriorate the postoperative wound healing and bleeding, increase

risks of pulmonary aspiration of gastric contents, fluid and electrolyte imbalance, delay hospital

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discharge and unexpected hospital admission, last but not least, increase stress and workload for the

operating theatre nurses.

1.2.2 Current Practice

When woman is seized with nausea, the current nursing practice in operating theatre is to encourage

her to breathe deeply so as to ease the symptom. While woman has the desire to vomit, nurses will

lower woman’s head and turn to the side, a kidney dish or container is used to collect the gastric

contents, then, clean the woman and change the bed sheet if necessary. Psychological support is

provided, to reassure the woman it is the common side effect of cesarean section under spinal

anesthesia. If nausea and vomiting persist, the operating theatre nurses have to inform the

anesthesiologist. Nurses will then administrate antiemetic drugs to the woman according to

anesthesiologist’s prescription

1.2.3 Needs for Improvement

Medicines can solve of those frustrating nausea and vomiting symptoms, at the same time, they are

frequently associated with adverse reactions that may have both short- and long-term effects. Two

common antiemetic medications use in operating theatre for cesarean section are Ondansetron and

Metoclopramide, a few associated adverse effects are reported, including the risk of allergy reaction,

dizziness, headache and abdominal discomfort. Moreover, it is still a controversy about the placental

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transfer and secretion in breast milk of drugs. (Balki. & Carvalho, 2005)

As a healthcare professional, potential side effects and risks to patients should always be avoided.

Routine medications to prevent nausea and vomiting are not recommended. However, there is no

evidence-based guideline for preventing and relieving these distressing symptoms, other than drugs.

1.2.4 Potential Innovation

Acupressure is a non-pharmacological intervention, origins from the traditional Chinese medicine,

based on the philosophy of balancing the “Qi” and regulating the energy flow between the earth and

life-beings. (Hickman, 2005) Acupressure wristband is the product in performing acupressure. It

comprises an elastic wristband incorporating a raised and smooth plastic button to apply skin pressure

at particular acupoint. (see Appendix 1)

P6 acupoint is the most commonly used to achieve the anti-emesis purpose. It is located on the

anteromedial aspect of the forearm between the tendons of flexor carpi radialis and palmaris longus

muscles, at a distance of three of the pregnant woman’s finger-breadths (approximately 5cm) from the

distal palmar crease (see Appendix 2). (Hickman, 2005) Studies have shown a significantly reduced the

intraoperative and postoperative nausea and vomiting for women having cesarean section under spinal

anesthesia. (Stein, et al., 1997, Duggal, et al., 1998, Harmon, et al., 2000, Chen, et al., 2005, Habib, et

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al. 2006, Ho, et al 2006, Noroozinia, et al., 2013)

Using acupressure wristband at P6 acupoint is the potential innovation in relieving nausea and

vomiting of women having cesarean section. It is simple, safe and of minimal cost. Non-pharmacologic

strategy is important. As a healthcare professional have to worry about the side effects of antiemetic

drugs, consequently, reduce the risks bring to patients.

1.3 Objectives and Significance

1.3.1 PICO

P: Women having cesarean section under spinal anesthesia

I: Acupressure wristband on P6 acupoint

C: Standard nursing care

O: Relieving nausea and vomiting

1.3.2 Research Question

For women having cesarean section under spinal anesthesia, how effective is the use of acupressure

wristband on P6 acupoint in comparison to standard nursing care in relieving nausea and vomiting in

operating theatre?

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1.3.3 Research Objectives

A. To systematically review and critically appraise studies investigating the use of acupressure

wristband in relieving nausea and vomiting for pregnant woman subjected to spinal anesthesia for

a cesarean section.

B. To develop evidence-based practice guideline on the use of acupressure wristband in relieving

nausea and vomiting for pregnant woman subjected to spinal anesthesia for a cesarean section.

C. To develop the implementation and evaluation plan for the evidence-based practice guideline on

the use of acupressure wristband in relieving nausea and vomiting for pregnant woman subjected to

spinal anesthesia for a cesarean section.

1.3.4 Significance

The application of acupressure wristband on P6 acupoint has been proven that can relieve nausea and

vomiting for women having cesarean section after spinal anesthesia, through the implementation of this

evidence-based guideline can lead to better patients’ outcomes and satisfactions. Although, the

pharmacological treatments can alleviate the symptoms, all medications have their side effects. Using

the non-pharmacological intervention, patient will not be delay discharged and will not lead to

unintended hospital readmission due to the drugs adverse effects.

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A better control of nausea and vomiting, in the prospect of surgeon, this can shorten the surgery times,

with fewer complications and better surgical outcomes. Therefore, surgeons can spend less time to deal

with patient’s complaints, work with less stress and workloads. (Soltani, et al., 2011)

By developing an evidence-based nursing care guideline, operating theatre nurses can easily grasp the

information about this innovative by using acupressure wristband to help relieve nausea and vomiting

for women having cesarean section after spinal anesthesia. Nurses can make their own judgment when

come across with this frustrating syndromes, providing the highest quality of nursing care by utilizing

this standardized and systematic guideline.

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CHAPTER 2:

Critical Appraisal

2.1 Search and Appraisal Strategies

2.1.1 Identification of Studies

Through the electronic resourses of The University of Hong Kong Libraries, four electronic databases,

including CINAHL Plus (EBSCOhost), PubMed, Cochrane Library and British Nursing Index

(ProQuest) were searched to identify the relevant articles about the use of P6 acupressure wristbands

for relieving nausea and vomiting for women having cesarean section under spinal anesthesia.

Studies were narrowed down to recent twenty years publications. It ranged from January 1993 to

August 2013, so as to providing the latest evidence. The search was performed without language

restrictions, and article type was limited to clinical trial. Furthermore, the search keywords were

considered under the PICO format:

P (Population): Cesarean Section, Spinal Anesthesia

I (Intervention): Acupressure, P6, Acupoint

O (Outcome): Nausea, Vomiting

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All items were searched separately and in combinations. Details of the search strategies and results are

described in Appendix 3.

2.1.2 Inclusion and Exclusion Criteria

Inclusion criteria:

Elective or Emergency Cesarean Section

Spinal Anesthesia

Acupressure at P6 acupoint

Nausea and vomiting as the primary outcome measures

Exclusion criteria:

Other surgeries

Normal Spontaneous Vaginal Delivery

General Anesthesia

Other interventions, e.g. acupuncture, electrical stimulation

Other acupoints

2.1.3 Data Extraction

The data from the 6 eligible studies were extracted and described in form of table of evidence. (see

Appendix 4) Meanwhile, the table of evidence was achieved from The Scottish Intercollegiate

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Guidelines Network (SIGN). Data was systematized into several categories, including bibliographic

citation, study type, level of evidence, patient’s characteristics, interventions(s), control, length of

follow up, outcome measures, effect sizes and results. In which, outcome measures considered were

included intraoperative nausea, intraoperative vomiting, postoperative nausea and postoperative

vomiting.

2.1.4 Appraisal Strategies

The appraisal tool was adopted from “SIGN 50: A guideline developer's handbook. Annex C”. This is

the Methodology Checklists developed by Scottish Intercollegiate Guidelines Network (SIGN). It is

used to assess the validity of the study. Two sections were involved in the checklist. Section one was

about the internal validity, ten questions were asked to assess how well the study was conducted.

Section two was about the overall assessment of study, four questions were asked to rate the overall

methodological quality of study. The ratings of level of evidence were ranged from 1++ to 4. With 1++

means the highest quality with very low risk of bias, while 4 is the lowest quality with high risk of bias.

(see Appendix 5) Details of the six studies appraised by the SIGN Methodology Checklists were

described in Appendix 6 & 6a.

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2.2 Results

2.2.1 Search Results

All searches were done on the 14th

August, 2013. Potential articles yielded by each electronic database

were screened for the titles and abstracts. All abstracts were scanned by meeting the the inclusion,

exclusion criteria, study type, and publication year (from January 1993 to August 2013). Relevant

articles were downloaded to retrieve full texts. One further relevant article by hand searching was

obtained from the citations of recruited articles. After removal of duplicated studies, a total of six

eligible studies were identified. Following table described the search results.

Databases Articles

Yielded

Article Excluded Eligible

Articles

CHINAL 1 N/A 1

PubMed 7

Three were excluded,

1. Intervention: Acupuncture

2. Intervention:Transcutaneous acupoint

electrical stimulation.

3. Outcome measure: Pain Relief

4

Cochrane Library 7 Three were excluded,





3. Outcome measure: Pain Relief

4

British Nursing Index 0 N/A 0

Hand Searching 1 N/A 1

Table 1: Search Result

Of these six research studies identified, one of them was Quasi-Experimental Design, and the other five

were Randomized Controlled Trials (RCTs). Details and characteristics of the six studies are outlined in

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the table of evidence. (see Appendix 4)

2.2.2 Methodological Issues

Clearly Focused Question

All these six studies clearly focused on questions, elements in the PICO format were mentioned. All

studies stated the aim or objective in introduction section. (Stein, et al., 1996, Duggal, et al., 1998,

Harmon, et al., 2000, Chen, et al, 2005, Ho, et al., 2006, Noroozinia, et al., 2013)

Sample Size:

Sample sizes were ranged from seventy-five to two hundred and forty-four participants.

By the power calculation of sample size, one study met the power of 0.9, (Harmon, et al., 2000), two

study met the power of 0.8, (Duggal, et al., 1998, Ho, et al., 2006), three studies did not reported the

power calculation. (Stein, et al., 1996, Ho, et al., 2006, Noroozinia, et al., 2013)

Allocation Concealment

All studies stated the assignment of participants into intervention group and control group were

randomized. Two studies indicated the allocation concealment by using sealed envelopes. (Stein, et al.,

1997, Ho, et al., 2006) One study used the table of random number. (Duggal, et al., 1998) Two studies

did not mentioned the concealment method, selection bias may be concerned. (Harmon, et al., 2000,

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Noroozinia, et al., 2013). And one is Quasi-Experimental Design, no randomization was involved.

(Chen, et al, 2005) Because of the convenience sampling, it may cause selection bias to results, for

which participants being compared are different.

Blinding

Four studies were double blind to both participants and research teams (Stein, et al., 1996, Duggal, et

al., 1998, Harmon, et al., 2000, Noroozinia, et al., 2013). Two studies were single blind to participants

only. (Ho, et al., 2006, Chen, et al., 2005)

To blind the participant, Stein et al. (1997) and Harmon et al. (2000) covered the acupressure wristband

by gauze. While Duggal, et al. (1998), Ho, et al. (2006) and Noroozinia, et al. (2013) used the identical

placebo wristbands. Performance bias should be considered when participants aware the difference

between two groups.

To blind the researcher, four studies recruited non-study team members, e.g. nurse and anesthetic

technician, to carry out the intervention. (Stein, et al., 1996, Duggal, et al., 1998, Harmon, et al., 2000,

Ho, et al., 2006, Noroozinia, et al., 2013) While Chen’s (2005) and Ho’s study (2006) were single blind

to the participants, as the principle researchers were responsible for applying the acupressure

wristbands. Experimenter bias would perhaps exist to influence study results, due to the researcher’s

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opinions and prejudices

Dropout

Dropout rates were low in these six studies. No participant dropped out in four studies. (Stein, et al.,

1996, Chen et al. 2005, Ho, et al., 2006, Noroozinia, et al., 2013) 7.8% dropped out in Duggal’s study

(1998) and 4% dropped out in Harmon’s study (2000). Dropout rates were regarded as low and

acceptable when the rate was below 20%. (SIGN, 2011)

Outcome Measure Tool

All six studies stated the primary outcome measure clearly, that was the intraoperative or/and

postoperative nausea and vomiting. Only Chen’s study (2005) also reviewed the pain and anxiety. Five

studies demonstrated the outcome measure tool in a standard, valid and reliable way. Four of these

studies assessed the nausea and vomiting by the visual analog scale. (Stein, et al., 1996, Duggal, et al.,

1998, Harmon, et al., 2000, Noroozinia, et al., 2013) And, Chen et al. (2005) assessed the nausea and

vomiting by the Rhodes Index. While, Ho, et al. (2006) did not mention the tool, the study concluded

the outcomes through asking and observing about the presence of nausea and vomiting. Measurement

bias would be questioned for which the measuring method does not match the research question.

Level of Evidence

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Among the six studies, five were Randomized Controlled Trials and one was Quasi-Experimental

Design. According the level of evidence developed by Scottish Intercollegiate Guidelines Network

(SIGN, 2011), the five Randomized Controlled Trials studies were rated as 1, while that of the

Quasi-Experimental Design was also rated as 1, since it was an experimental clinical trial (Chen et al.,

2005).

Finally, with four studies were rated as 1++ with highest quality and very low risk of bias (Stein, et al.,

1996, Duggal, et al., 1998, Harmon, et al., 2000, Noroozinia, et al., 2013), one study rated as 1+ with

low risk of bias (Ho, et al., 2006) and one study rated as 1- with high risk of bias (Chen et al., 2005).

2.3 Summary of Data

2.3.1 Population

Of these six studies, one was conducted in New York (Stein, et al., 1997), one was from Canada

(Duggal, et al., 1998), one was from Ireland (Harmon, et al., 2000), two was from Taiwan (Chen et al.,

2005, Ho, et al., 2006), and one was from Iran (Noroozinia, er al., 2013).

2.3.2 Number of participants

Of these six studies, the total number of participants was seven hundreds and seventy-nine.

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2.3.3 Patient characteristics

The mean ages of participants were within 29 to 32 years old, and the mean weights were within 69 to

78 kilograms in these six studies. Around 30% participants were primiparous in four studies. (Stein, et

al., 1996, Duggal, et al., 1998, Chen, et al., 2005, Ho, et al., 2006). While Harmon’s study (2000)

recruited around 66% parimiparas. Only Chen’s study (2005) set the gestational age at 36 to 42 weeks

as the recruitment criteria, the mean gestational ages were within 38.4-38.7 weeks in four studies.

(Duggal, et al., 1998 Harmon, et al., 2000, Chen, et al., 2005, Ho, et al., 2006). Two studies stated

healthy pregnancy women were recruited (Stein, et al., 1996, Duggal, et al., 1998), the other four

studies stated pregnancy women of ASA (American Society of Anesthesiologists) physical state I

and/or II were recruited (Harmon, et al., 2000, Chen, et al., 2005, Ho, et al., 2006, Noroozinia, et al.,

2013). Five studies enrolled the elective cesarean section under spinal anesthesia cases (Stein, et al.,

1996, Duggal, et al., 1998, Harmon, et al., 2000, Ho, et al., 2006, Noroozinia, et al., 2013). One study

enrolled both elective and emergency cesarean section under spinal anesthesia cases, 71.2% were

elective and 28.8% were emergency cases (Chen, et al., 2005)

2.3.4 Intervention

Three studies used the bilateral acupressure wristband on P6 acupoint (Stein, et al., 1996, Duggal, et al.,

1998, Ho, et al., 2006), two studies used unilateral acupressure wristband on P6 acupoint (Harmon, et

al., 2000, Noroozinia, et al., 2013). All of above five studies used the same brand elastic wristband with

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a small round plastic button attached on it. While one study applied three bilateral acupressure

treatments on P6 acupoint in three periods. (Chen, et al., 2005)

The intervention starting times were different, including thirty minutes preoperatively (Harmon, et al.,

2000, Noroozinia, et al., 2013), fifteen minutes preoperatively (Stein, et al., 1996), five minutes

preoperatively (Harmon, et al., 2000) and immediate preoperatively (Duggal, et al., 1998).

2.3.5 Control

Four studies used the placebo acupressure wristbands on the identical sites of the intervention group.

Ho’s study (2006) used the wristbands with blunted plastic buttons. Other three studies used the

wristbands without the buttons (Stein, et al., 1996, Duggal, et al., Noroozinia, et al., 2013) Harmon’s

study (2000) used the same acupressure wristband on the non-P6 acupoint. And Chen’s study (2005)

performed nursing instruction instead.

2.3.6 Length of follow up

Stein’s study (1997) followed up within the intraoperative period only. Noroozinia’s study (2013)

followed up for six hours after operation. Duggal’s (1998) and Chen’s (2005) studies followed up for

10 hours after operation. And Harmon’s study (2000) followed up for 24 hours after operation.

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2.3.7 Outcome measures

Two study involved the intraoperative nausea and vomiting only (Stein, et al., 1996, Ho, et al., 2006),

one studies involved the postoperative nausea and vomiting only (Chen, et al, 2005), and three studies

involved both intraoperative and postoperative nausea and vomiting. (Duggal, et al., 1998, Harmon, et

al., Noroozinia, et al., 2013)

2.3.8 Effect Size

Intraoperative Nausea

Five studies concluded the result for intraoperative nausea. Stein’s study (1997) showed the greatest

improvement, 52% participants were fewer in intervention group to show intraoperative nausea

(p<0.001). With two studies, 21.3% (Harmon, et al., 2000) and 13.8% (Noroozinia, et al., 2013) fewer

participants showed intraoperative nausea (p<0.05). Another two studies 3% (Duggal, et al., 1998) and

7% (Ho, et al., 2006) fewer participants showed intraoperative nausea (p>0.05).

Intraoperative Vomiting

Five studies concluded the result for intraoperative vomiting. Noroozinia’s study (2013) showed the

greatest improvement, 14.4% participants were fewer in intervention group to show intraoperative

vomiting (p<0.002). With three studies, 12% (Stein, et al., 1997), 8.6% (Harmon, et al., 2000), 5% (Ho,

et al., 2006), 0% (Duggal, et al., 1998) fewer participants showed intraoperative vomiting (p>0.05).

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Postoperative Nausea

Four studies concluded the result for intraoperative vomiting. Noroozinia’s study (2013) showed the

greatest improvement, 25% participants were fewer in intervention group to show postoperative nausea

at two hours after cesarean section (p<0.001). While Chen’s study showed 17.3% fewer participants

showed postoperative nausea at eight hours after cesarean section (p<0.05). With two studies, 9%

(Duggal, et al., 1998) and 4.2% (Harmon, et al., 2000) fewer participants showed postoperative nausea

(p>0.05).

Postoperative Vomiting

Four studies concluded the result for intraoperative vomiting. Harmon’s study (2000) showed the

greatest improvement, 25.5% participants were fewer in intervention group to show intraoperative

vomiting (p<0.01). Chen’s study (2005) showed 5.8% fewer participants showed postoperative

vomiting (p<0.05). Duggal’s study (1998) showed 5% fewer participants showed postoperative

vomiting (p>0.05). While, Noroozinia’s study (2013) showed no different among two groups.

2.4 Synthesis of Data

2.4.1 Evidence-Based Recommendations

Target Group

All pregnant women having elective cesarean section under spinal anesthesia. (Stein, et al., 1996,

22

Duggal, et al., 1998, Harmon, et al., 2000, Ho, et al., 2006, Noroozinia, et al., 2013) Although Chen’s

study (2005) also advised to recruit women having emergency cesarean section. There were no further

studies in supporting this view.

The Innovation

The application of bilateral acupressure wristbands was suggested. Three studies promoted the use of

bilateral wristbands. (Stein, et al., 1996, Duggal, et al., 1998, Ho, et al., 2006) All these studies showed

the reduction in nausea and vomiting in using bilateral acupressure wristband. Two studies promoted

the use of unilateral wristband. (Harmon, et al., 2000, Noroozinia, et al., 2013). However, Harmon’s

study applied on right hand and Noroozinia’s study (2013) applied on left hand. Their interventions

were not consistent in supporting each other.

The Acupoint

P6 acupoint was suggested. All studies applied the acupressure wristbands on the P6 acupoint, and

showed the reduction in nausea and vomiting for women having cesarean section under spinal

anesthesia. (Stein, et al., 1996, Duggal, et al., 1998, Harmon, et al., 2000, Chen, et al, 2005, Ho, et al.,

2006, Noroozinia, et al., 2013) The P6 acupoint is easily accessed, which is 3 fingers breathe below the

distal wrist between palmaris longus and flexor carpi radialis tendons. In order to provide the optimal

effect, the correct site should be well located by nurses.

23

Best Timing for Application

Acupressure wristbands was suggested to apply thirty minutes before spinal anesthesia. Although the

starting times were different among studies, Ho’s (2006) and Noroozinia’s study (2013) recommended

the application of wristband thirty minutes preoperatively. Noroozinia explained that early application

can prevent drugs in triggering nausea and vomiting chemoreceptor zone in the medulla.

Duration

The duration of application of acupressure wristband on P6 acupoint for at least 6 hours or more was

suggested. Four studies had applied wristband for at least 6 hours or more, all showed positive effect in

relieving intraoperative and postoperative nausea and vomiting. (Duggal, et al., 1998, Harmon, et al.,

2000, Chen, et al, 2005, Noroozinia, et al., 2013)

2.4.2 Side Effects

Localized discomfort on the wrist was the most common side-effect, Duggal’s study (1998) revealed

17.6% patients complained of tightness, swollen hands, and itchy wrists. At the same time, high

participants’ acceptability of acupressure wristbands in the Duggal’s study (1998) was also reported,

while other studies showed no major complaints of localized discomfort (Stein, et al., 1996, Harmon, et

al., 2000, Chen, et al, 2005, Ho, et al., 2006, Noroozinia, et al., 2013).

24

Infusion and blood circulation problem was the second side-effect for the application of acupressure

wristbands. In order to confirm that the blood flow and intravenous access were not interfered, pulse

oximetry was suggested to place on the index finger of the same hand of acupressure wristbands. (Stein,

et al., 1997, Noroozinia, et al., 2013)

25

Summary

After the integrative review and summary of studies, as an non-pharmacological and safe intervention,

evidences show that bilateral acupressure wristbands on P6 acupoint is effectively in relieving intra-

and postoperative nausea and vomiting for women having cesarean section after spinal anesthesia,

carried in the operating theatre.

26

CHAPTER 3

Implementation Potential

Previous chapters have been described about the impact of nausea and vomiting on pregnant woman

subjected to spinal anesthesia following a cesarean section in operating theatre. And, evidences are

explored and support that nausea and vomiting can be well relieved by acupressure wristbands.

In this chapter, the implementation potential of acupressure wristband on pregnant women will be

discussed for its transferability, feasibility and the cost-benefit ratio of this innovation in local practice.

3.1 Transferability of the Findings

3.1.1 Target Audience

The target audience involves all healthy pregnant women undergo elective cesarean section following

spinal anesthesia.

According to the statistics of target hospital in 2012, pregnant women underwent cesarean sections

were around 31 years old with average gestational age of 38 weeks, and more than 95% of elective

27

cesarean sections were undergone spinal anesthesia. The patient’s characteristics are similar for the age,

gestational age and the mode of anesthesia as all the reviewed studies. (Stein, et al., 1996, Duggal, et al.,

1998, Harmon, et al., 2000, Chen, et al, 2005, Ho, et al., 2006, Noroozinia, et al., 2013) For those

proposed audiences are those women admit for elective caesarean sections, which shares the same

operative type with five reviewed studies. (Stein, et al., 1996, Duggal, et al., 1998, Harmon, et al., 2000,

Ho, et al., 2006, Noroozinia, et al., 2013) Approximately, 75 elective cesarean sections are performed

per month, 900 pregnant women per year benefit in this proposed guideline.

3.1.2 Target Setting

The target setting is implemented in the operating theatre of a Hong Kong public hospital governed by

The Hospital Authority. In the target hospital, there is one operating theatre to work for cesarean

section. And, the labor ward is located next to the operating theatre, which works adjunctively as the

pre-operation waiting room runs by operating theatre nurse. Among the reviewed article, all studies

were conducted in hospital setting. (Stein, et al., 1996, Duggal, et al., 1998, Harmon, et al., 2000, Chen,

et al, 2005, Ho, et al., 2006, Noroozinia, et al., 2013) And, the acupressure wristband is applied either

in operating theatre (Stein, et al., 1996, Duggal, et al., 1998, Harmon, et al., 2000) or the pre-operation

waiting room. (Ho, et al., 2006, Noroozinia, et al., 2013) To conclude, the proposed guideline is similar

and fits the target setting comparing with the six studies.

28

3.1.3 Philosophy of Care

The target hospital was established in 1911 as the first hospital on the Kowloon peninsula. Throughout

this one hundred year, hospital has been all along upholding the philosophy of "To heal the sick and to

relieve the distressed”. The nursing is committed to contribute towards providing diversified and high

quality patient-centered care for the people. (TWGHs, 2013)

As such philosophy of care is the same as the reviewed studies; both share the same idea of nurse’s role.

Nurse should take care of the physical, psychological and spiritual well-being of pregnant women. The

proposed innovation of the acupressure wristbands aims at relieving nausea and vomiting, minimizing

the emotional distress related to symptoms and enhancing pregnant woman’s recovery. This

intervention can ensure the high quality patient-centered nursing care.

3.1.4 Time for Implementation and Evaluation

The proposed guideline would take a year for preparation, implementation and evaluation. The

following table describes the timeline for developing the guideline on the use of acupressure wristband

according to the suggestion by SIGN (2011)

29

Steps Month

1 2 3 4 5 6 7 8 9 10 11 12

Preparation

Staff Training

X X

Pilot Study X X X

Analyzing pilot data

Amending the guideline

X

Implementing the guideline X X X X X X

Auditing X X X

Evaluation X

Reporting X

Table 2: Timeline for developing the use of acupressure wristband guideline

3.2 Feasibility

3.2.1 Autonomy of Nursing Staff

The application of the acupressure wristband provides operating theatre nurse a wide range of

autonomy. Advanced practicing nurses and nursing officers can join the guideline implementation team,

take part in evaluating and amending the guideline, also provide supervision on nurses. Registered

nurses and enrolled nurses, with the help of the evidence-based clinical guideline, can make their own

judgment of applying the acupressure wristband in order to relief nausea and vomiting of pregnant

women, and terminating it when they find an undesirable outcome on patients. This can promote the

independent nursing practice and enhance job satisfaction (Ming, 2002)

3.2.2 Staff Training

All operating theatre nurses are required to attend a 2-hour in-service training session to learn the

30

proper skill of using acupressure wristband. This training covers the theoretical knowledge on

acupressure, e.g. basic theory about rebalancing yin, yang and qi on P6 acupoint in relieving nausea

and vomiting. It also includes the teaching on the practical skill of the use of wristband, e.g. P6

acupoint location, time and length of pressing, and the strength and depth of pressure. Also, the

assessment skill after application will be taught, e.g. the skin condition, the tightness of the wristband

and the intensity of nausea and vomiting of patients. Furthermore, journal articles, textbooks and

handouts about acupressure wristband should be available to staffs for circulating. (Davies, 2002)

Therefore, staffs can be more familiar to the innovation, reducing their stress on handling, increasing

the feasibility of implementation.

3.2.3 Organizational and Administrative Support

The target department encourages effective, efficient and high quality of peri-operative nursing care.

The department operation managers and ward managers emphasize on evidence-based nursing, there is

already an existing team on searching the most updated nursing journals and post on notice board in

operating theatre regularly. Moreover, the department always encourages staffs in writing

evidence-based guidelines for procedures and the use of instruments. With the detailed discussion and

clearly written evidence-based guideline proposal can help in achieving the support by the department.

(Melnyk & Fineout-Overholy, 2011)

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3.2.4 Equipment and Resources

A seminar room is required for nursing staffs in-service trainings, extra resources such as computer,

projector, lecture notes and stationeries are also necessary during training sessions. The sales of the

Acupressure Wristband Company can be the external assistance to help in the demonstration of

applying technique, teaching the maintenance and disinfection method.

In order to ensure staffs can seek the information on the use of acupressure wristband easily, e.g.

textbooks, handouts and video tape should be available in the learning corner of operating theatre.

The proposed acupressure wristbands have also be purchased.

3.2.5 Evaluation Tools

Internal team meeting will be held after the pilot study to discuss about the difficulties come across

during intervention and the best way to carry out, so as to amending the guideline before promoting to

the nursing staffs.

Process evaluation is made to review the difficulties on applying the acupressure wristband to

pregnancy women. Nurses will be reviewed about the helpfulness of the innovation in providing

smoother nursing care.

32

Outcome evaluation will assess the overall outcomes. Nurses and participants are invited for taking part

in evaluation survey about the effectiveness of the acupressure wristband in relieving nausea and

vomiting for pregnant woman having cesarean section following spinal anesthesia. The overall

incidence of nausea and vomiting reduced by the intervention is also measured and compared. By

revising the staffs and participants’ comments and suggestions, all information is pulled together and

makes modification on the evidence-based guideline.

3.3 Costs-Benefit Ratio of the Innovation

3.3.1 Material Costs

The material cost of implementation is mainly composed of staff’s training, the proposed equipment

and the maintenance expenses. Also, other minor costs include the fee for photocopying of materials

and the CD for video recording of training session. By comparing the material cost of implementation

with the cost of medication used in reliving nausea and vomiting for pregnancy women, the

costs-benefit of the innovation can be calculated. The approximate net saving per patient is $105.6, and

the approximate net saving per year is $95000 after implementing this innovation. The costs-benefit of

implementation is summarized in Appendix 7.

3.3.2 Non-Material Costs

Patients may find it uncomfortable and irritate by the wristband on their wrists, although adverse

33

effects are rare and no serious harm is reported in the reviewed studies. Skin rash and poor circulation

can be the side-effects by this innovation and can upset patient’. This can result in disappointing the

patients, rising the number of complaints, and deteriorating the reputation of hospital.

Moreover, changing of practice can interfere current nurse’s function; nurses may be frustrated in

adapting the new guideline. This can increase the stress on work because of handling the new

equipment. (Melnyk & Fineout-Overholy, 2011) Finally, nurses may be distressed by the innovation

and unpredicted treatment outcome, decrease job satisfaction, increase staff absenteeism and turnover.

3.3.3 Potential Barriers and Solution of Innovation

Barrier to patient:

Acupressure wristband is new to patient in Hong Kong Hospital. Patient may refuse the use of

acupressure wristband.

Solution:

Patients are explain about the benefits of using the acupressure wristband, and evidences are provided

that acupressure wristband is safe and is already widely used in western countries. Consent has to be

signed by patient for who agrees with the intervention.

34

Barrier to nurses:

Nurses may worry about the increased workload by the innovation. Moreover, the use of acupressure

wristband can distress them, as this is a new knowledge to their usual practice.

Solution:

Nurses are reassured that the appropriate use of acupressure wristband can reduce their workloads.

Sufficient training is provided before the implementation, the detail of the intervention will be taught

and explained.

3.3.4 Potential Benefits of Innovation

Benefit to patient:

With the adequate explanation and communication with patients before providing the acupressure

wristband can help patient in gaining confidence and knowledge of acupressure. Patients are respected

for their rights to report abnormalities and stop the treatment. Moreover, diminishing nausea and

vomiting by the acupressure wristband can result in fewer complications; better surgical results and

happier patients. (Soluani, et al, 2011)

Benefit to nurses:

In-service training is included before the implementation of new guideline, nurses can gain the

theoretical knowledge and practical skills about acupressure. For an effective acupressure wristband

35

application, nurses can also reduce the time in managing the complication of nausea and vomiting,

increase the quality of care and staff morale.

Benefit to organization:

As acupressure does not rely on the use of drugs, it is an innovation without the risk of adverse effect

by medication. (Hickman, et al., 2005) Therefore, the cost of antiemetic drugs can be reduced, the

length of hospital stay can be shorten, and also prevent patients from the chances of hospital

readmission due to the side effects of pharmacological treatment. Therefore, the overall hospital service

standard is improved.

36

CHAPTER 4

Evidence-Based Practice Guideline

4.1 Title

An evidence-based guideline of using acupressure wristband in relieving nausea and vomiting for

pregnant woman subjected to spinal anesthesia for a cesarean section.

4.2 Aims and Objectives

The aim of this guideline is to:

- Minimize the episode of nausea and vomiting for pregnant woman subjected to spinal anesthesia

for a cesarean section.

The objectives of this guideline are to:

- Summarize the clinical evidence for the use of acupressure wristband for pregnant woman

subjected to spinal anesthesia for a cesarean section.

- Formulate clinical guideline for the use of acupressure wristband for pregnant woman subjected to

spinal anesthesia for a cesarean section by the best evidence-based practice.

37

- Standardize the use of acupressure wristband for pregnant woman subjected to spinal anesthesia


4.3 Target Group

The guideline is intended to guide the operating theatre nurses on the care of all pregnant women

subjected to spinal anesthesia for elective cesarean sections.

4.4 Recommendations

The guideline is developed based on the six reviewed articles (Appendix 8). The evidence of these

reviewed articles are graded according to the Level of Evidence (SIGN, 2011), and the

recommendations suggested are graded according to the Grade of Recommendation. (SIGN, 2011)

(Appendix 5)

Recommendation 1.0

Standard baseline monitor should be performed to screen for patient’s condition.

Grade of recommendation: A

- Nurses should pay attention to patient’s baseline condition, e.g. blood pressure, oxygen saturation

and electrocardiogram. Pulse oximetry is placed to confirm the blood flow to the fingers without

hindered by the wristband.

38

(Stein, et al, 1997 [1++], Harmon, et al., 2000 [1++])

- The non-invasive arterial pressure measurements were taken every minute during the cesarean

section and every three minutes in the recovery room, in order to monitor the hypotension induced

due to delivery.

(Stein, et al, 1997 [1++], Harmon, et al., 2000 [1++], Ho, et al., 2006 [1+], Noroozinia, et al, 2013

[1++])

Recommendation 2.0

The position of intravenous cannula should be placed distal to the wristband


- The intravenous cannula is placed distal to the acupressure wristband, although suitable tightness

of the wristband is adjusted beforehand, in order to ensure at no time did the pressure of the

wristbands interfere with intravenous fluid administration

(Stein, et al, 1997 [1++])

Recommendation 3.0

Routine supplement of oxygen should be administrated to patients.


- Studies suggested the oxygen therapy can reduce the hypotension correlated nausea, 5L/min

39

oxygen by face mask is suggested by reviewed studies.

(Stein, et al, 1997 [1++], Harmon, et al., 2000 [1++], Noroozinia, et al, 2013 [1++])

Recommendation 4.0

A combination of the use of acupressure wristband and antiemetic drug

administration should be considered for patients with intolerable nausea and

vomiting.


- On top of the use of the acupressure wristband, antiemetic drug should also be allowed for patient

experiencing intractable vomiting, but the amount of medication should be recorded and

minimized.

(Harmon, et al., 2000 [1++], Ho, et al., 2006 [1+], Noroozinia, et al, 2013 [1++])

Recommendation 5.0

Side effects should be noted by nurses throughout the whole process.


- Reviewed studies showed patients are used to well-tolerated to the wristbands. Some minor side

effects should still be alerted by nurses, e.g. tightness of band, swollen hands, problems with

infusion and itching wristed.

40

(Duggal, et al., 1998 [1++], Harmon, et al., 2000 [1++])

Recommendation 6.0

Acupressure wristband applies on the Pericardium 6 (P6) should be used to

relieve nausea and vomiting.


- Acupressure is non-invasive and easily performed procedure by nurses to enhance the quality of

nursing care, and the P6 acupoint is extensively used in reviewed studies.

(Stein, et al, 1997 [1++], Duggal, et al., 1998 [1++], Harmon, et al., 2000 [1++], Chen, et al., 2005 [1-],

Ho, et al., 2006 [1+], Noroozinia, et al, 2013 [1++]).

- The activation of this point is to balance the flow of “qi” and harmonizes the stomach. It is located

bilaterally on the anterior surface of the wrists, between the flexor carpi radialis muscle and the

palmaris longus tendon, at a distance of three finger breadths from the wrist crease. (Appendix 2)

(Stein, et al, 1997 [1++], Duggal, et al., 1998 [1++], Harmon, et al., 2000 [1++], Chen, et al., 2005

[1-], Ho, et al., 2006 [1+], Noroozinia, et al, 2013 [1++]).

41

Recommendation 7.0

Bilateral acupressure wristbands should be applied 30 minutes before spinal

anesthesia and for at least 6 hours or more.


- More studies investigated on the application of bilateral acupressure wristbands and show the

positive effect on the relief of nausea and vomiting.

(Stein, et al, 1997 [1++], Duggal, et al., 1998 [1++], Ho, et al., 2006 [1+]).

- The initiation time is recommended at 30 minutes before spinal anesthesia, as this can allow time

to eliminate stimulation over the chemoreceptor trigger zone of vomiting.

(Ho, et al., 2006 [1+], Noroozinia, et al, 2013 [1++]).

- The wristband should be continuously applied at P6 acupoint for at least 6 hours, so as to ensure

the effect by the acupressure wristband and reduce the need for anti-emetic drugs.

(Duggal, et al., 1998 [1++], Harmon, et al., 2000 [1++], Chen, et al., 2005 [1-], Noroozinia, et al, 2013

[1++]).

42

CHAPTER 5

Implementation Plan

The implementation plan involves the communication strategies and the pilot study plan. A

well-designed communication plan has its essential role during the implementation phase, which can

help in exchanging information and sharing the meaning with the stakeholders. The pilot study is an

important process to test the feasibility of the intervention, through ongoing decision making and the

management of unpredicted events before implementation.

5.1 Communication Plan

5.1.1 Identification the Stakeholders

Stakeholder is someone who can affect or be affected by the proposed intervention, it is essential to

gain support from the stakeholders. The key stakeholders in this local setting involved:

1) Department Operational Manager (DOM) and Chief of Service (COS) of the Department of

Gynecology and Obstetrics: The policy makers who have the authority in approving the

implementation, and allocating resources and funding.

2) Surgeons: The key doctor who is responsible for the pregnancy women undergoing cesarean

43

section.

3) Anesthetist: The key doctor who is managing spinal anesthesia and monitoring the symptoms of

nausea and vomiting.

4) Ward Manager: The person who is responsible for monitoring overall process, quality and

outcome of the implementation.

5) Nursing Officer (NO)/ Advanced Practice Nurse (APN): The person who are skillful in clinical

area, they can fully understand the procedure and utilization of acupressure wristbands. While the

NO/APN in the implementation team, should also responsible for the assessment, planning,

implementation, diagnosis and evaluation throughout the implementation.

6) Operating Theatre Nurse: The frontline nurses who apply the acupressure wristbands to the target

patients.

7) The pregnant woman subjected to spinal anesthesia for s cesarean section: The customer who

receives the intervention.

5.1.2 Initiating the Change

The gaps of current practice will be discussed with the DOM and ward manager, e.g. the side effects of

the anti-emetic drugs, money spent and time wasted on handling nausea and vomiting. While, the latest

evidence will be presented, that can increase the likelihood of the need of change, e.g. the innovation is

the non-pharmacological approach to reduce nausea and vomiting, and is a simple, safe and of minimal

44

cost. Moreover, in reassuring those opposed frontline nurses, group meeting with the implementation

team is welcomed to clarify the concern and misunderstanding. Consensus with all nursing

stakeholders towards a better practice in relieving nausea and vomiting for pregnancy women

undergoing cesarean section will be the goal.

With the support from organization, the innovation in-charge APN will then hold a formal presentation

about the new guideline to the COS of the Department of Gynecology and Obstetrics and the

Department of Anesthesiology in seeking their support and approval.

5.1.3 Guiding the Change

The implementation team includes the proposer, one NO/APN in-charge, and four senior nurses as the

coordinators. The implementation team will organize the 2-hour training sessions for all operating

theatre nurses. The background and content of guideline, knowledge and technique of using the

innovation, timelines of implantation will be announced to all stakeholders in the training sessions and

through intranet e-mail. The implementation team will help in solving questions raised from time to

time; so as to facilitate the guideline is functioning on the right track. The guideline will be uploaded

on department intranet and the written copy will also be kept in the operating theatre’s learning corner

for easy access.

45

5.1.4 Sustaining the Change

The implementation team is responsible to sustain the change process. They assess the compliance of

the frontline nurses through regular auditing, monitor the guideline’s critical success factors through

outcome measurement, and on-going develop understandings with stakeholders to enable them to

provide feedback on important stage-based guideline outcomes.

5.2 Pilot Study Plan

The purpose of the pilot study is a small study to help developing a further confirmatory study. It helps

to find out the feasibility of the proposed change, to avoid any unpredicted troubles and problems

during the implementation period, to evaluate the tools and to modify the proposed guideline, and also

to investigate the acceptability of the intervention by staffs and patients.

5.2.1 Timeline for pilot study

For this proposed guideline, pilot study will last for 3 months, including

1) 8-week pilot test

All women reach the standard of inclusion and exclusion criteria written in the proposed guideline

during this period will be enrolled.

2) 4-week pilot data analyzing and guideline amending

The implementation team will collect data by clinical audit, outcome measurement and feedbacks from

46

stakeholders for further evaluation.

Steps Weeks

1 2 3 4 5 6 7 8 9 10 11 12

Pilot Test X X X X X X X X

Data Analyzing & Guideline Amending X X X X

Table 3: Timeline for pilot study

5.2.2 Data Collection

The recruited patient’s detail including age, weight, gestational age and the health status will be

retrieved from the Clinical Management System (CMS), while the incidence of vomiting and nausea,

undesired effect and patient’s feedback will be documented in the assessment form by frontline nurses

during the procedure. The implementation team collects and computerizes the data every week.

Furthermore, the implementation team will perform clinical audit every 2 week for 2 months, to check

for the compliance of staff and the accuracy of documentation. The frontline nurse will also be

interviewed regarding to the satisfaction towards the training session and the proposed guideline after

the clinical audit.

5.2.3 Guideline Revision

After the pilot test, the feasibility of intervention is analyzed and guideline amendment will take 2

weeks. The implementation team will first investigate the data, and summarize into a written report.

The team will then discuss the analyzed data and gathered feedback with the ward manage and DOM

47

for further evaluation. According to the evaluation results, guideline will be revised, and the amended

guideline will be presented to the COS of the Department of Gynecology and Obstetrics and the

Department of Anesthesiology to seek their final approval. Ethical approval will be obtained by the

Hospital Ethics Committee for safeguarding patient’s right.

48

CHAPTER 6

Evaluation Plan

According to the problem defined and outcomes obtained, it is important to develop an evaluation plan

to assess the effectiveness of new innovation, by comparing the patient outcomes, healthcare provider

outcomes and system outcomes before and after the implementation of the new guideline.

6.1 Identification of Outcomes

6.1.1 Patient Outcome

The patient’s outcome is by determining whether the acupressure wristband can reduce the incidence of

nausea and vomiting of pregnancy women subjected to spinal anesthesia for cesarean sections or not.

The effectiveness of the new innovation can be evaluated by the intensity of nausea rated by patients

and the number of incidence of vomiting recorded by nurses during the implementation period (see

Appendix 9). Visual Analog Scale (VAS) is applied to assess the intensity of nausea, patients can

simply indicate the severity of nausea on the 10 points horizontal line with the word and picture

descriptions. Meanwhile, nurses will record the number of episode occurred as the assessment for the

incidence of vomiting. And, patient’s satisfaction towards intervention will also be investigated by

49

using the 5-point Likert scale questions

6.1.2 Healthcare Provider Outcome

Staff self-reported satisfaction questionnaire is applied to measure the healthcare provider outcomes

(see Appendix 10). Questions are related to the nurse’s satisfaction, skill and knowledge gained and

their confidence in utilizing the new innovation. The questionnaire is in a 5-point Likert scale. Nurses

are also encouraged to leave comments and suggestions in the last part of questionnaire for further

improvement.

6.1.3 System Outcome

The cost effectiveness of using new guideline by comparing with original practice will be the system

outcome. The overall material and non-material cost of using new guideline is expected can reduce the

cost of using antiemetic medication, patient’s adverse effects occurred, time of handling patient’s

complaints and nurse’s workload than in previous setting.

6.2 Nature and Number of Clients

The target patients will be the pregnant women in all ages. Once, the pregnant woman is prepared for

cesarean section with the mode of spinal anesthesia in the operating theatre within the implementation

period, will be recruited as eligible participant. All target patients will be followed up from the day of

50

operation until the end of the implementation.

As a reference to an online sample size calculator, (Roasoft, 2004) under the margin of error 5% and

the confidence level of 95% with the population size of 400.Under these criteria, to detect the

significance in the reducing the severity of nausea and the incidence of vomiting, 197 participants are

necessary to be recruited by convenience sampling in the evaluation plan.

6.3 Length of Measurement

Different length of measurement is depended on different kind of outcome measured. The proposed

guideline will be implemented and analyzed for a 6-month intermediate length of measurement.

The baseline patient’s outcome, the severity of nausea and the incidence of vomiting without new

innovation, will be measured and documented 1 month before implementation for data comparison.

The estimated sample size of 197 participants will be recruited within the 4-month implementation

period. And 1 month will be required for the data analysis.

For the measurement of staff satisfaction level regarding to the new guideline and the cost effectiveness

towards this new innovation, data will be obtained before the start of the implementation and at the end

of the implementation within this 6 months.

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6.4 Data Analysis

At the end of the implementation, data will be obtained from patient’s outcome and satisfaction &

staff’s satisfaction assessment form and analyzed. (see Appendix 9 & 10)

For the patient’s outcome, the severity of nausea is measured by using 10 points Visual Analog Scale,

score divides from 0 (No nausea feeling) to 10 (The highest intensity), the higher the point indicated

the more severe the nausea experienced. The data will be computerized for aggregate analysis, with a

two-tailed paired t-test at the 5% significant level, by comparing the severity of nausea of target

pregnancy women before and after applying the new innovation. Furthermore, the number of vomiting

occurred will be analyzed by mean and standard deviation under a 95% confidence interval.

For the healthcare provider outcome, the data regarding to the knowledge, workloads, confidence in

applying and the acceptance of the new guideline are measured. The data is quantized by using the

5-point Likert scale questionnaire, with score 1 (Strongly disagree) to 5 (Strongly agree), the higher

mean score represents the higher level of satisfaction of staff towards the new guideline. The data will

then be compared and analyzed by using the two-tailed paired t-test. And, comments from staff towards

the new guideline will be transcribed and indexed into textual data for generating analytical categories

and the key themes. Meanings and explanations will then be explored and clarified.

52

For the system outcome, costs of implementation including personnel expenses and material costs

would be summed up and calculated at the end of the implementation.

6.5 Basis for the Effective Guideline

The basis for determining the effectiveness of guideline depends whether the defined outcome is met.

The data and evidence achieved from the reviewed literatures are also taken into consideration. If the

outcome measures of the innovation are similar to the reviewed literatures, the new guideline can be

considered effective and adopted.

Regarding to the reviewed literatures, the rate of nausea and vomiting reported to be 50-80% for the

pregnancy women undergoing cesarean section, (Harmon, et al., 2000, Chen, et al., 2005, Noroozinia,

et al., 2013) so if the incidence of nausea and vomiting can be reduced less than this rate after the use

of acupressure wristbands, it is considered as a significant effective.

For the mean score for severity of nausea measured by the 10 points Visual Analog Scale, it is

considered to be effective with the score is equal or less than 5 after the use of acupressure wristbands.

And the occurrence of vomiting is estimated can impose a 50% reduction in number. Staff satisfaction

level on the new guideline should at least score 3 out of the 5-point Likert scale, which means staffs

accept the use of new guideline. The estimated cost for the whole innovation is $17950/year, which

53

should be lower than the original cost.

54

CHAPTER 7

Conclusion

The non-pharmacological technique of using acupressure wristband at the P6 point is effective in

relieving nausea and vomiting for pregnancy women subjected to spinal anesthesia for a cesarean

section. As long as the use of acupressure wristband has no major side effects, is easy to apply and

economical. This new evidence based guideline is beneficial to patients, healthcare providers and

hospital. And this new innovation is recommended to be promoted and adopted.

55

Appendix 1: Acupressure Wristband

Photo Source: http://www.segelservice.com/Seaband-Akupressurband.html

56

Appendix 2: P6 Acupoint

Photo Source: http://www.motion-sickness-guru.com/acupressure-wrist-bands-and-bracelets.html

57

Appendix 3: Search Strategies and Results

Database 1: CINAHL Plus via EBSCOhost

Date of search: 14th August 2013

Search Number Search Keywords Results

#1 Cesarean Section 10148

#2 Spinal Anesthesia 2551

#3

#4

#5

#6

#7

#8

#1 and #2

Acupressure

P6

Acupoint

#4 or #5 or #6

Nausea

662

826

548

237

1529

9136

#9 Vomiting 8907

#10

#11

#12

#8 and #9

#3 and #7 and #10

#3 and #7 and #10

Limit to Research Article

6060

2

1

Limit to Jan 1993 - Aug 2013

Total number of citation yielded: 1

58


Database 2: PubMed

Date of search: 14th

August 2013



#2

#3

Spinal Anesthesia

#1 and #2

19423

2517

#4 Acupressure 692

#5

#6

#7

P6

Acupoint

#4 or #5 or #6

3833

5504

9682

#8 Nausea 46709

#9 Vomiting 58440

#10

#11

#12

#8 and #9

#3 and #7 and #10

#3 and #7 and #10

Limit to Clinical Trial


29149

9

7


59


Database 3: Cochrane Library




#2 Spinal Anesthesia 3563

#3 #1 and #2 791

#4 Acupressure 489

#5

#6

#7

#8

#9

#10

#11

#12

P6

Acupoint

#7 or #8 or #9

Nausea

Vomiting

#8 and #9

#3 and #7 and #10

#3 and #7 and #10

Limit to Trials

166

770

1047

17240

13628

9241

8

7



60


Database 4: British Nursing Index via ProQuest




#2

#3

#4

Spinal Anesthesia

#1 and #2

Acupressure

23

2

71

#5 P6 14

#6 Acupoint 6

#7

#8

#9

#10

#11

#4 or #5 or #6

Nausea

Vomiting

#8 and #9

#3 and #7 and #10

85

516

373

331

0


61

Appendix 4: Table of Evidence

Bibliographic

citation

Study type

& Level of

Evidence

No. of patients (n)

& Patient’s

characteristics

Intervention Control Length of

follow up

Outcome measures Effect size

Remarks

Stein,

et al. (1997)

RCT

(1++)

n=75

-Healthy pregnant

women

-Undergoing

elective cesarean

section

-Under spinal

anesthesia

A: Bilateral,

Acupressure Bands at

P6 acupoints+ 2ml

Intravenous saline

M: Bilateral,

Placebo Wristband at

P6 acupoints + 10mg

Intravenous

Metoclopramide

Both applied 15

minutes

preoperatively

C: Bilateral,

Placebo Wristbands

at P6 acupoints +

2ml Intravenous

saline

Applied 15 minutes

preoperatively

Intra-

operative

period

1. Intraoperative

nausea

2. Intraoperative

vomiting

3. Intraoperative

nausea

(Hypotensive

patients)

1. A(24%), C(76%), (p<0.001)

M(16%), C 76%), (p<0.001)

A(24%), M(16%), (p>0.05)

2. A(12%), C(24%), (p>0.05)

3. A(37.5%), C(78.9%), (p<0.05)

M(23.5%), C(78.9%), (p<0.01)

A(27.5%), M(23.5%),(p>0.05)

1. Both A & M can relieve

nausea and vomiting,

while A was with no side

effects.

2. Routine supplemental

oxygen by face mask was

provided to reduce

hypotension correlated

nausea.

Duggal,

et al. (1998)

RCT

(1++)

n=244 (263-19)

-Healthy pregnant

women

-Undergoing

elective caesarean

A: Bilateral,

Acupressure

wristbands at P6

acupoints

Applied immediately

C: Bilateral,

Placebo wristbands

at P6 acupoints

Applied

Minimum

10 hours

after

insertion

of spinal

1. Intraoperative

Nausea

2. Intraoperative

Vomiting

1. A(27%), C(30%), (p>0.05)

2. A(7%), C(7%) , (p>0.05)

1. P6 point acupressure

was benefit to women

with previous nausea and

vomiting

62

section

-Under spinal

anesthesia

preoperatively immediately

preoperatively

3. Postoperative

nausea

4. Postoperative

vomiting

3. A(57%), C(66%), (p>0.05)

Patients with previous history

of post-operative nausea:

A(55.6%), C(85%), (p<0.05)

4. A(41%), C(46%), (p>0.05)

Patients with previous history

of post-operative vomiting

A(41.7%), C(67.5%), (p<0.02)

2. High patient

acceptability of

wristbands was reported

Side-Effects of

Wristbands:

17.6% of patients

complaint of tightness,

swollen hands, problems

of infusion and itching

wrists.

Harmon,

et al. (2000)

RCT

(1++)

n=94

-ASA I pregnant

women

-Aged 18-40 years

-Undergoing

elective caesarean

section

-Under spinal

anesthesia

A: Unilateral,

Acupressure

wristband at right

forearm P6 acupoint

Applied 5 minutes

preoperatively

C: Unilateral,

Acupressure

wristband at right

forearm non-P6

acupoint

Applied 5 minutes

preoperatively

24 hours

after

operation

1. Intraoperative

nausea

2. Intraoperative

vomiting

3. Postoperative

nausea

4. Postoperative

vomiting

1. A(14.9%),C(36.2%),(p=0.018)

2. A(8.5%), C(17%), (p=0.21)

3. A(8.5%), C(12.7%), (p=0.50)

4. A(27.7%),C(53.2%),(p=0.011)

1.P6 point acupressure is

effective, without major

side effects, easily handle

and cost effective.

Side-Effects of

Wristbands:

Localized discomfort in a

small number of women

63

5. Incidence of

nausea and

vomiting

(excluded who

received

anti-emetic)

6. Anti-emetic

required

5. A(13%), C(50%), (p=0.0002)

6. A(25%), C(50%),(p=0.01)

Chen,

et al.(2005)

Quasi-

Experimental

Design

(1-)

n=104

-Post-anesthesia

ASA II

-36-42 weeks

pregnant

-Undergoing

elective/

emergency

cesarean section

(CS)

-Under spinal

anesthesia

A: Bilateral,

Three 20mins

acupressure

treatments at P6

acupoints

1: Night prior to CS

2: 2-4 hours after CS

3: 8-10 hours after CS

C: Three nursing

instructions

1: Night prior to

cesarean section

2: 2-4 hours after

CS

3: 8-10 hours after

CS

10 hours

after

operation

1. Nausea at 2-4

hours after CS

2. Vomiting at

2-4 hours after

CS

3. Nausea at 8-10

hours after CS

4. Vomiting at

8-10 hours

after CS

1. A(23.1%), C(30.8%), (p=0.08)

2. A(15.4%), C(15.4%), (p>0.05)

3. A(7.7%),C(25.0%),(p=0.00)

4. A(0%), C(5.8%), (p<0.05)

1.P6 point acupressure

was suggested to reduce

nausea and vomiting, and

also anxiety and pain.

2. P6 point acupressure

gave improvement to

physiological indices.

(e.g. pulse, respiratory,

blood pressure)

64

Ho, et al.

(2006)

RCT

(1+)

n=110

-ASA physical

status I/II

-Aged 23-40 years

-Undergoing

elective cesarean

section

-Under spinal

anesthesia

A:Bilateral,

Acupressure

wristbands at P6

Acupoints

Applied 30 minutes

preoperatively

A:Bilateral,

Placebo wristbands

at P6 Acupoints

Applied 30 minutes

preoperatively

During

operation

1. Intraoperative

nausea

2. Intraoperative

vomiting

1. A(64%), C(71%), (p=0.416)

2. A(22%), C(27%), (p=0.506)

1. Acupressure wristbands

were ineffective to relieve

nausea and vomiting

(Author set the success

incidence rate: drop from

65% to 39%.)

Noroozinia,

et al. (2013)

RCT

(1++)

n=152

-ASA I/II

pregnant women

-Undergoing

elective cesarean

section (CS)

-Under spinal

anesthesia

A: Unilateral,

Acupressure

wristband at

dependent hand P6

point

Applied 30 minutes

preoperatively

C: Unilateral,

Elastic band at

dependent hand P6

point

Applied 30 minutes

preoperatively

6 hours

after

operation

1. Intraoperative

Nausea

2. Intraoperative

vomiting

3. Nausea in

recovery room

4. Nausea at 2

hours after CS

5. Nausea at 4

hours after CS

6. Nausea at 6

hours after CS

1. A(13.2%), C(27%),( p=0.001)

2. A(0%), C(14.4%),(p=0.002)

3. A(2.6%), C(18.4%), (p=0.002)

4. A(7.9%), C(32.9%), (p=0.001)

5. A(3.9%), C(27.6%), (p=0.001)

6. A(0%), C(5.3%), (p=0.001)

1.30 minutes prior to

surgery is the best timing

for acupressure

application, so as to

eliminate stimulation over

chemoreceptor trigger

zone of vomiting

65

Appendix 5: Levels of Evidence & Grades of Recommendation

Levels of Evidence

1++ High quality meta-analyses, 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 reports, 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 level 3 or 4; or

Extrapolated evidence from

Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is

based. It does not reflect the clinical importance of the recommendation.

66

SIGN

Methodology Checklist 2: Controlled Trials Appendix 6

Study identification (Include author, title, year of publication, journal title, pages)

Chen, H.M., Chang, F.Y., Hsu, C.T. (2005) Effect of acupressure on nausea, vomiting, anxiety and pain among

post-cesarean section women in Taiwan. Kaohsiung Journal of Medical Science. 21(8): 341-350

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question. Yes

1.2 The assignment of subjects to treatment groups is randomised.

No. Quasi-Experimental

Design, using convenience

sampling by assigning

participants into groups

1.3 An adequate concealment method is used. No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. No.Single Blind to participants

1.5 The treatment and control groups are similar at the start of the trial. Yes

1.6 The only difference between groups is the treatment under investigation. Yes

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes.Clearly stated the use of

Rhodes Index for Nausea and

Vomiting.(Cronbach’s a=0.98)

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was completed?

0%

1.9 All the subjects are analysed in the groups to which they were randomly

allocated (often referred to as intention to treat analysis).

Does not apply

1.1

0

Where the study is carried out at more than one site, results are

comparable for all sites.

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Not RCT (-)

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes

2.4 Notes. Summarise authors’ conclusions. Add any comments on your own assessment of the study, and the

extent to which it answers your question and mention any areas of uncertainty raised above.

This was a Quasi-Experimental Design. No randomization was involved, authors stated that was for preventing participants to

discuss the details of study and biased their response. It only single blinded to the participants, which may cause experimenter

bias.

67

SIGN



Duggal, K.N., Gouglas, M.J., Peter, E.A., Merrick, P.M. (1998) Acupressure for intrathecal narcotic-induced nausea and

vomiting after caesarean section. International Journal of Obstetric Anesthesia. 7: 231-236




1.2 The assignment of subjects to treatment groups is randomised. Yes

1.3 An adequate concealment method is used. Yes. Using the table of random

number

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Double Blind



1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes. Clearly stated the use of

10cm (Nausea) Visual Analogue

Scale, and Number of vomiting

1.8 What percentage of the individuals or clusters recruited into each treatment

arm of the study dropped out before the study was completed?

7.8%. It may contribute to

attrition bias, but the rate is

acceptable.



Yes

1.1

0

Where the study is carried out at more than one site, results are comparable

for all sites.

Does not apply


2.1 How well was the study done to minimise bias? High Quality (++)


evaluation of the methodology used, and the statistical

power of the study, are you certain that the overall

effect is due to the study intervention?

Yes



Yes



This was the Randomized Control Trial. Author stated that randomization was involved, using the table of random

number for allocation. Double blind to participants and the researchers can lower the risk of bias. Although there was

7.8% dropout rate, it was within the acceptable range.

68

SIGN



Harmon, D., Ryan, M., Kelly, A., Bowen, M. (2000) Acupressure and prevention of nausea and vomiting during

and after spinal anesthesia for caesarean section. British Journal of Anesthesia: 84(4): 463-467





1.3 An adequate concealment method is used. Can’t say. Allocation

concealment method did not

report

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes.

Double Blind




0-10 (Nausea and Vomiting)

Visual Analogue Scale.



4%. It may contribute to attrition

bias, but the rate is acceptable.



Yes

1.1

0



Does not apply


2.1 How well was the study done to minimise bias? High quality (++)





Yes



Yes

2.4 Notes. Summarise authors’ conclusions. Add any comments on your own assessment of the study, and the extent to

which it answers your question and mention any areas of uncertainty raised above.

This was the Randomized Control Trial. Author stated that randomization was involved, however the allocation concealment

method did not report well. Double blind to participants and the researchers can lower the risk of bias. Although there was 4%

dropout rate, it was within the acceptable range.

69

SIGN



Noroozinia, H., Mahoori, A., Hasani, E., Gerami-Fahim, M, & Sepehrvan, N. (2013) The effect of acupressure on

nausea and vomiting after cesarean section under spinal anesthesia. Journal of Acta Medica Iranica. 51(3):

163-167





1.3 An adequate concealment method is used.

Can’t say. Allocation

concealment method did not

report

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes Double Blind




0-10(Vomiting) & 0-100(Nausea)

Visual Analogue Scale



0%



Yes

1.1

0



Does not apply







Yes



Yes



This was the Randomized Control Trial. Author stated that randomization was involved, however the allocation

concealment method did not report well. Double blind to participants and the researchers can lower the risk of bias.

70

SIGN



Stein, D.J., Birnback, D.J., Danzer, B.I., Kuroda, M.M., Grunebaum, A. & Thys, D.M. (1997) Acupressure versus

intraoperative metoclopramide to prevent nausea and vomiting during spinal anesthesia for cesarean section.

Anesthesia and Analgesia. 84: 342-345





1.3 An adequate concealment method is used. Yes. By using sealed envelope

system

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes. Double Blind




0-10 (Nausea and Vomiting)

Visual Analogue Scale



0%



Yes

1.1

0



Does not apply







Yes



Yes



This was the Randomized Control Trial. Author stated that randomization was involved, the allocation concealment

method was by the sealed envelope. Double blind to participants and the researchers can lower the risk of bias.

71

SIGN



Ho, C.M., Tsai, H.J.; Chan, K.H.; Tsai, S.K. (2006) P6 acupressure does not prevent emesis during spinal

anesthesia for cesarean delivery. Anesthesia and Analgesia.102(3), 900-903





1.3 An adequate concealment method is used.

Yes By using sealed envelope

system

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. No. ngle Blind



1.7 All relevant outcomes are measured in a standard, valid and reliable way. Can’t say. Study did not mention

the tool, but by asking and

observing.



0%



Yes

1.1

0



Does not apply


2.1 How well was the study done to minimise bias? Acceptable (+)





Yes



Yes



This was the Randomized Control Trial. Author stated that randomization was involved, the allocation concealment method

was by the sealed envelope. Single blind to participants only, as the researcher carried out the intervention may cause the

experimenter bias. Moreover, there was no standard outcome measure tool mention in the study.

72

SIGN Methodology Checklist: Controlled Trials Appendix 6a

Study Identification Stein, et al.,

(1997)

Duggal, et

al., (1998)

Harmon, et

al., (2000)

Chen, et

al., (2005)

Ho, et al.,

(2006)

Noroozinia,

et al,(2013)

The study addresses an appropriate and clearly focused question

The assignment of subjects to treatment groups is randomized ×

An adequate concealment method is used × × ×

Subjects and investigators are kept ‘blind’ about treatment allocation × ×

The treatment and control groups are similar at the start of the trial

The only difference between groups is the treatment under

investigation

All relevant outcomes measured in a standard, valid and reliable way ×

What percentage of the individuals or clusters recruited into each treatment

arm of the study dropped out before the study was completed?

0% 7.8% 4.0% 0% 0% 0%

All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Not Apply



Not Apply Not Apply Not Apply Not Apply Not Apply

How well was the study done to minimise bias? 1++ 1++ 1++ 1- 1+ 1++

Taking into account clinical considerations, your evaluation of the

methodology used, and the statistical power of the study, are you

certain that the overall effect is due to the study intervention?

Are the results of this study directly applicable to the patient group

targeted by this guideline?

73

Appendix 7: Costs-Benefit of Implementation

Costs of Implementation (Personnel Expenses)

Items Duration Costs & Time Total Costs

Staff Costs

16 Advanced Practice Nurse 1 hour Training Session $270/hour X 16 $4320

68 Registered Nurse 1 hour Training Session $170/hour X 68 $11560

Total: $15880

$17.6/patient

Costs of Implementation (Materials Cost)

Items Costs & Amount Total Costs

Equipment Costs

Acupressure Wristband $60 X 20 $1200

Maintenance Costs

Spare Acupressure Wristband $60 X 5 $300

Alcohol Pad for Disinfection $0.4 X 900 case/year $360

Other Costs

Photocopying Fee --- $200

CD for video recoding --- $10

Venus Fee --- Available in Hospital

Total: $2070/year

$2.3/patient

Benefit (Saving) of Implementation

Items Costs & Amount Total Costs

Ondansetron 2mg/ml/Ample $95 X 450 patients $42750

Tropisetron 5mg/ml/Ample $156 X 450 patents $70200

Total: $112950/year

$125.5/patient

Net Saving Per Patient: $125.5-($17.6+ $2.3) = $105.6

Net Saving Per Year: $112950- ($15880+ $2070) = $95000

74

Appendix 8: Use of Acupressure Wristband Guideline

Evidence-based guideline of using acupressure wristband

in relieving nausea and vomiting for pregnant woman

subjected to spinal anesthesia for a cesarean section

Aims:

To minimize the episode of nausea and vomiting for pregnant woman subjected to spinal anesthesia


Objectives:

To standardize the use of acupressure wristband for pregnant woman subjected to spinal anesthesia


Target Group:

All pregnant women subjected to spinal anesthesia for elective cesarean sections.

Recommendations:

1. Ensure the acupressure wristband is in good function.

2. Assess patient’s skin condition before applying the acupressure wristband.

3. Acupressure wristband is on the Pericardium 6 (P6).

4. Bilateral acupressure wristbands are applied 30 minutes before spinal anesthesia and last for at

least 6 hours or more.

5. Intravenous cannula should place distal to the wristband.

6. Routine supplement of oxygen should be administrated to patients.

7. A combination of the use of acupressure wristband and antiemetic drug administration can be

considered for patients with intolerable nausea and vomiting.

8. Standard baseline monitor should be conducted thorough the procedure.

9. Side effects are noted by nurses throughout the procedure.

10. Document the skin conditions before and after the application of acupressure wristband.

Outcomes:

1. Nausea and vomiting on pregnant women subjected to spinal anesthesia for a cesarean section is

relieved.

2. Patient is free from the side effects caused by improper use of acupressure wristband.

3. Accurate records are documented.

75

Appendix 9: Patient Outcome and Satisfaction Assessment Form

Assessment Form of

Using Acupressure Wristband

for Pregnant Woman

subjected to Spinal Anesthesia

for Cesarean Section

Date: Mode of Anesthesia:

Diagnosis: Operation:

Surgeon: Anesthetist:

Scrub Nurse: Runner:

Intensity of Nausea:

Rate the intensity of nausea from 1 to 10 (Visual Analog Scale)

No Nausea Feeling Severe Nausea Feeling

1 2 3 4 5 6 7 8 9 10

Incidence of Vomiting:

Record the time of vomiting

Time

1. : 5. : 9. :

2. : 6. : 10. :

3. : 7. : 11. :

4. : 8. : 12. :

Undesired Effect of Acupressure Wristband: YES / NO

If YES, type of undesired effect: __________________________________________

Consumption of Antiemetic Medication: YES / NO

If YES, name of antiemetic medication: ____________________________________

Patient’s Satisfaction Rate: (Circle the Choice)

1:Highly Dissatisfied 2:Dissatisfied 3:Neutral 4:Satisfied 5:Highly Satisfied

Patient’s Gum Label

76

Appendix 10: Staff Self-Reported Satisfaction Questionnaire

Staff Self-Reported Satisfaction Questionnaire

Evaluation of the use of acupressure wristband in relieving nausea and vomiting for pregnant women

subjected to spinal anesthesia for Cesarean Section.

We would be grateful to have your feedbacks and suggestions on this new innovation for further

improvement.

Please circle the followings:

1 = Highly Disagree 2 = Disagree 3 = Neutral 4 = Agree 5 = Highly Agree

Training Session:

1. Content of training session is relevance 1 2 3 4 5

2. Content of training session is well understood 1 2 3 4 5

3. Duration of training session is appropriate 1 2 3 4 5

4. Format of training session is appropriate 1 2 3 4 5

5. Competent of using new guideline after training 1 2 3 4 5

Implementation of the New Guideline:

1. Easy to understand and follow the new guideline 1 2 3 4 5

2. Competent to the use of new guideline 1 2 3 4 5

3. Adequate resource and material are provided 1 2 3 4 5

4. Adequate support and help is available 1 2 3 4 5

5. New guideline is beneficial to patients 1 2 3 4 5

6. New guideline is beneficial to staffs 1 2 3 4 5

7. Support the use of new guideline 1 2 3 4 5

Other comment(s):

Thank You

77

References

Balki. M. & Carvalho, J.C. (2005) Intraoperative nausea and vomiting during cesarean section under

regional anesthesia. International Journal of Obstetric Anesthesia. 14(3):230-41.

Chen, H.M., Chang, F.Y., Hsu, C.T. (2005) Effect of acupressure on nausea, vomiting, anxiety and pain

among post-cesarean section women in Taiwan. Kaohsiung Journal of Medical Science. 21(8): 341-350

Davies, B.L. (2002) Sources and models for moving research evidence into clinical practice. Journal of

Obstetric, Gynecologic, and Neonatal Nursing, 31, 558-562

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