PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial

Cooke, Marie, Rickard, Claire, Rapchuk, Ivan, Shekar, Kiran, Marshall, Andrea P., Comans, Tracy, Doi, Suhail, McDonald, John and Spooner, Amy (2014) PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial. BMJ Open, 4 11: 1-6. doi:10.1136/bmjopen-2014-006179


Author Cooke, Marie
Rickard, Claire
Rapchuk, Ivan
Shekar, Kiran
Marshall, Andrea P.
Comans, Tracy
Doi, Suhail
McDonald, John
Spooner, Amy
Title PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2014-11-13
Year available 2014
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1136/bmjopen-2014-006179
Open Access Status DOI
Volume 4
Issue 11
Start page 1
End page 6
Total pages 6
Place of publication London United Kingdom
Publisher B M J Group
Collection year 2015
Language eng
Formatted abstract
Introduction Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach.

Methods and analysis 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36 h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV.

Ethics and dissemination Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results.

Trial registration number
Australian New Zealand Clinical Trials Registry—ACTRN12614000589684.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2015 Collection
School of Public Health Publications
School of Medicine Publications
 
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