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,
1. Intervention:Transcutaneous acupoint
electrical stimulation.
2. Intervention:Transcutaneous acupoint
electrical stimulation.
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,
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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.
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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).
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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)
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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 post- operative nausea and vomiting for women having cesarean section after spinal anesthesia,
carried in the operating theatre.
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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
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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.
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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)
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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
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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.
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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
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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.
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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
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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.
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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.
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- Standardize the use of acupressure wristband for pregnant woman subjected to spinal anesthesia
for a cesarean section.
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.
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(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
Grade of recommendation: A
- 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.
Grade of recommendation: A
- Studies suggested the oxygen therapy can reduce the hypotension correlated nausea, 5L/min
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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.
Grade of recommendation: A
- 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.
Grade of recommendation: A
- 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.
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(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.
Grade of recommendation: A
- 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++]).
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Recommendation 7.0
Bilateral acupressure wristbands should be applied 30 minutes before spinal
anesthesia and for at least 6 hours or more.
Grade of recommendation: A
- 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++]).
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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should be lower than the original cost.
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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.
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Appendix 1: Acupressure Wristband
Photo Source: http://www.segelservice.com/Seaband-Akupressurband.html
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Appendix 2: P6 Acupoint
Photo Source: http://www.motion-sickness-guru.com/acupressure-wrist-bands-and-bracelets.html
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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
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Appendix 3: Search Strategies and Results
Database 2: PubMed
Date of search: 14th
August 2013
Search Number Search Keywords Results
#1 Cesarean Section 46333
#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
Limit to Jan 1993 - Aug 2013
29149
9
7
Total number of citation yielded: 7
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Appendix 3: Search Strategies and Results
Database 3: Cochrane Library
Date of search: 14th August 2013
Search Number Search Keywords Results
#1 Cesarean Section 3640
#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
Limit to Jan 1993 - Aug 2013
Total number of citation yielded: 7
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Appendix 3: Search Strategies and Results
Database 4: British Nursing Index via ProQuest
Date of search: 14th August 2013
Search Number Search Keywords Results
#1 Cesarean Section 881
#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
Total number of citation yielded: 0
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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
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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
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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)
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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
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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.
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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.
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Methodology Checklist 2: Controlled Trials Appendix 6
Study identification (Include author, title, year of publication, journal title, pages)
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
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. 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
1.5 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
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.
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
Yes
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? High Quality (++)
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 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.
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Methodology Checklist 2: Controlled Trials Appendix 6
Study identification (Include author, title, year of publication, journal title, pages)
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
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. Yes
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
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
0-10 (Nausea and Vomiting)
Visual Analogue Scale.
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
4%. It may contribute to attrition
bias, but the rate is acceptable.
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
Yes
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? High quality (++)
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 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.
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Methodology Checklist 2: Controlled Trials Appendix 6
Study identification (Include author, title, year of publication, journal title, pages)
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
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. Yes
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
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
0-10(Vomiting) & 0-100(Nausea)
Visual Analogue Scale
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).
Yes
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? High quality (++)
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 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.
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Methodology Checklist 2: Controlled Trials Appendix 6
Study identification (Include author, title, year of publication, journal title, pages)
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
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. Yes
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
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
0-10 (Nausea and Vomiting)
Visual Analogue Scale
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).
Yes
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? High quality (++)
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 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.
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Methodology Checklist 2: Controlled Trials Appendix 6
Study identification (Include author, title, year of publication, journal title, pages)
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
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. Yes
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
1.5 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. Can’t say. Study did not mention
the tool, but by asking and
observing.
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).
Yes
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? Acceptable (+)
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 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.
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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
Where the study is carried out at more than one site, results are
comparable for all sites.
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?
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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
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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
for a cesarean section.
Objectives:
To standardize the use of acupressure wristband for pregnant woman subjected to spinal anesthesia
for a cesarean section.
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.
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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
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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
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