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

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Complementary medicine
Protocol
PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial
  1. Marie Cooke1,
  2. Claire Rickard1,
  3. Ivan Rapchuk2,
  4. Kiran Shekar3,
  5. Andrea P Marshall4,
  6. Tracy Comans5,
  7. Suhail Doi6,
  8. John McDonald7,
  9. Amy Spooner8
  1. 1NHMRC Centre for Research Excellence in Nursing Interventions, Griffith Health Institute, Centre for Health Practice Innovation, Nathan, Queensland, Australia
  2. 2Department of Anaesthesia and Perfusion, Critical Care Research Group, The Prince Charles Hospital, Chermside, Queensland, Australia
  3. 3Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Chermside, Queensland, Australia
  4. 4Griffith Health Institute, Centre for Health Practice Innovation and Gold Coast University Hospital, Gold Coast, Queensland, Australia
  5. 5Griffith Health Institute, Population and Social Health Research Program, Brisbane, Queensland, Australia
  6. 6Department of Clinical Epidemiology Unit, School of Population Health, University of Queensland, Herston, Queensland, Australia
  7. 7Microbiology and Immunology Research Group, Griffith University, Gold Coast, Queensland, Australia
  8. 8Critical Care Research Group, The Prince Charles Hospital, Chermside, Queensland, Australia
  1. Correspondence to Professor Marie Cooke; m.cooke{at}griffith.edu.au

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.

  • COMPLEMENTARY MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-006179

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