Complementary Therapies in Medicine (2015) 23, 372—380

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.elsevierhealth.com/journals/ctim

Wrist acupressure for post-operative nausea and vomiting (WrAP): A pilot study Marie Cooke a,∗, Ivan Rapchuk b, Suhail A. Doi c, Amy Spooner d, Tameka Wendt d, Jessica Best d, Melannie Edwards d, Leanda O’Connell d, Donna McCabe d, John McDonald e, John Fraser f, Claire Rickard a a

NHMRC Centre for Research Excellence in Nursing Interventions, Menzies Health Institute Queensland, Centre for Health Practice Innovation, Australia b Department of Anaesthesia and Perfusion, Critical Care Research Group, The Prince Charles Hospital, Australia c Research School of Population Health, Australian National University, Australia d Critical Care Research Group, Adult Intensive Care Services, The Prince Charles Hospital, Australia e Microbiology and Immunology Research Group, Griffith University, Australia f Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Australia Available online 28 March 2015

KEYWORDS Postoperative nausea and vomiting; Cardiac surgery; Acupressure



Summary Post-operative nausea and vomiting are undesirable complications following anaesthesia and surgery. It is thought that acupressure might prevent nausea and vomiting through an alteration in endorphins and serotonin levels. In this two-group, parallel, superiority, randomised control pilot trial we aimed to test pre-defined feasibility outcomes and provide preliminary evidence for the efficacy of PC 6 acupoint stimulation vs. placebo for reducing post-operative nausea and vomiting in cardiac surgery patients. Eighty patients were randomly assigned to either an intervention PC 6 acupoint stimulation via beaded intervention wristbands group (n = 38) or placebo sham wristband group (n = 42). The main outcome was assessment of pre-defined feasibility criteria with secondary outcomes for nausea, vomiting, rescue anti-emetic therapy, quality of recovery and adverse events. Findings suggest that a large placebo-controlled randomised controlled trial to test the efficacy of PC 6 stimulation on PONV in the post-cardiac surgery population is feasible and justified given the preliminary clinically significant reduction in vomiting in the intervention group in this pilot. The intervention was tolerated well by participants and if wrist acupressure of PC 6 acupoint is proven effective in a large trial it is a simple non-invasive intervention that could easily be incorporated into practice. © 2015 Elsevier Ltd. All rights reserved.

Corresponding author. Tel.: +61 737355253. E-mail address: m.cooke@griffith.edu.au (M. Cooke).

http://dx.doi.org/10.1016/j.ctim.2015.03.007 0965-2299/© 2015 Elsevier Ltd. All rights reserved.

Wrist acupressure for post-operative nausea and vomiting

Introduction The burden of caring for patients post cardiac surgery in the Australian healthcare system is huge, with the Australian Institute of Health and Welfare (AIHW) annual report identifying that around 179,000 procedures of the cardiovascular system were performed between 2011 and 12.1 Cardiovascular disease is one of the major expensive disease groups in Australia, costing about $7.9 billion in 2008—2009, with over half of this spent on patients admitted to hospital.2 Reported rates of post-operative nausea and vomiting (PONV) for cardiac surgery patients vary. Studies from the 1990s through to 2014 indicate that the incidence of PONV post cardiac surgery has remained high, with rates reported from 26% to 54.1%,3—6 and a Korean study finding 71% in the placebo arm of a trial testing the efficacy of ondansetron and ramosetron in reducing PONV.7 Patients rank nausea the fourth and vomiting the most undesirable of 10 negative post-operative outcomes8 and patient dissatisfaction with anaesthetic care is strongly related to PONV.9 PONV can delay transfer from the recovery unit by up to 20 min,8 and also delay hospital discharge or result in readmission. Vomiting can produce imbalances in body electrolytes, cause bleeding and place tension on sutures and wounds8 and disrupt absorption of medications resulting in dysrhythmias, fluid volume overload and pain leading to post-operative complications for cardiac surgery patients.3 Patients may also be reluctant to actively participate in post-operative recovery activities such as mobilising, and deep breathing if they have PONV.3 It is also reported that cardiac surgery patients can experience persistent gastrointestinal symptoms including nausea up to 4—6 weeks post surgery.3 A systematic review has concluded that PONV is reported to affect around 80 of every 100 individuals and that if all 100 were given an antiemetic about 28 would benefit.10 Evidence suggests that acupressure might limit PONV associated with anaesthesia/PONV.11 Acupressure has been practised for centuries and is a traditional Chinese medicine based on life energy (Qi) flowing through channels in the body known as meridians.12 Acupressure, it is posited, restores equilibrium to disturbances affecting the body’s homeostasis by stimulating specific points (acupoints) that link meridians to body organs.12 The mechanism for the action of acupressure has not been scientifically investigated fully, but it is thought that it may prevent nausea and vomiting through alterations in serotonin and endorphin levels.13 Stimulation of the PC 6 acupoint for treating nausea and vomiting was reported in the early 1990s.14 The World Health Organisation (WHO) endorses acupressure as a therapeutic intervention15 and a consensus on acupuncture point locations was reached by WHO (Western Pacific Regional Office) and guidelines published.16 The PC 6 acupoint is the meridian point in the pericardium channel, located on the inner forearm between the extensor carpi radialis and palmaris longus tendons, one sixth of the distance from PC 7 on the medial wrist crease to PC 3 in the cubital fossa.16 For this current study the PC6 acupoint was determined by measuring the distance between the palmar wrist crease and inner forearm with a tape measure, and placing the bead on the wristband between the two tendons a sixth of the distance measured. This method

373 is much more accurate than the previously used procedure of using the three middle fingers on the inside of the patient’s wrist to measure distance. PC 6 acupoint can be stimulated using a range of methods (e.g. acu-stimulation device, acupressure, acupuncture, capsicum plaster), however stimulation of the correct acupoint is the crucial issue.11 A recent Cochrane systematic review and meta-analysis of 40 trials totalling 4858 participants reported a clear positive effect of PC 6 acupoint stimulation on nausea (RR 0.71, 95% CI: 0.61—0.83); vomiting (RR 0.70, 95% CI: 0.59—0.83); and, need for rescue anti-emetics (RR 0.69, 95% CI: 0.57—0.83).11 There was however heterogeneity of studies in this review with studies conducted in various clinical settings and with different populations, suggesting that, ‘on average’, the intervention is known to be effective. The report of the quality of the studies reviewed indicated concerns regarding allocation sequence generation and allocation concealment. There is an evident need for a large rigorously designed and implemented placebo-controlled RCT to test the efficacy of PC 6 stimulation on PONV in the post-cardiac surgery population. Undertaking a feasibility study initially, however ensures that such a subsequent larger trial is methodologically rigorous, feasible, and economically justifiable.17,18 As such, this pilot study purpose was to obtain reference data, test feasibility, obtain effect estimates and identify potential problems19 that could feedback to and inform the design of a future definitive research protocol.

Materials and methods Design The WrAP pilot study was a two-group, parallel, superiority, RCT that randomly assigned post-operative adult cardiac surgery patients to PC 6 acupoint stimulation via a beaded wrist band or no stimulation using a sham non-beaded wrist band. The participants were post-operative adult cardiac surgery patients. Feasibility outcomes were defined a priori as: Eligibility: ≥75% of patients screened will be eligible; Recruitment: ≥70% of eligible participants will agree to enrol; Protocol fidelity: ≥95% of participants in intervention group will have their wristbands correctly positioned for 36 h post admission to the ICU: Retention: 21 cm • Impaired renal function — creatinine level >200 or eGFR 35 as an exclusion criterion but when the wristbands were placed on one male participant, it was obvious that they were too tight and thus this participant was excluded after randomisation. There is only one adult size Seaband® wristband. We measured the man’s wrist and it was 22 centimetres so we changed the exclusion criterion from BMI > 35 to wrist circumference >21 cm. Five male participants in the non-beaded group had their wristbands removed before the 36 h period due to the bands feeling too tight. A further five participants felt the bands were uncomfortable/tight but did not need them removed.

9 (24%) 22 (58%) 6 (16%) 1 (3%) 27.8 (4.9) 195.7 (57.9) 250.6 (53.8) 90.7 (42.9) 22 (61%) 9 (25.0%) 26 (74.3%) 6 (15.8%) 77.2 (12.5) 37.4 (30.8)

8 (19%) 24 (57%) 10 (24%) 0 (0%) 27.7 (4.9) 192.5 (60.9) 239.1 (61.3) 85.6 (47.6) 26 (63%) 17 (41.5%) 29 (70.7%) 4 (9.5%) 72.8 (12.0) 35.5 (34.0)

patient prior to surgery. Participants were advised that they could withdraw from the study at any time, and that withdrawal would not jeopardise any treatment or relationship with relevant hospitals. The pilot trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000416796). Seaband® acupressure bands are a registered medical device with the Australian Register of Therapeutic Goods (ARTG109529).

Results

Discussion The lessons learned from this pilot are useful in conceiving and planning a larger trial of N = 526 which would be adequate to detect statistically significant differences in

Wrist acupressure for post-operative nausea and vomiting

Figure 1

377

Participant flow.

Cumulave event rate (%)

60 50 40 Voming (B)

30

Voming (NB) 20

Late nausea (B)

10

Late nausea (NB)

0 6

9

12

16

20

24

36

Time in hours

Figure 2 Cumulative incidence of nausea and vomiting at study time-points. This line chart was plotted using Kaplan—Meier survivor functions calculated over the full data and evaluated at indicated times*.

378

M. Cooke et al.

Table 4 Comparison of PONV, nausea and vomiting rates (percent of total subjects that had any of the defined outcomes over observation period). Outcome

Worst case imputation

Complete case analysis

Beaded %

Non-beaded %

P value

Beaded %

Non-beaded %

P value**

PONV

63.1

64.3

1.0

61.1

63.4

1.0

Nausea Any Early Late*

63.2 57.9 52.6

57.1 50 40.5

0.65 0.51 0.37

60 50 48.6

55 46.2 35.9

0.82 0.81 0.35

Vomiting Any* Early Late

29 34.2 18.4

42.9 33.3 23.8

0.25 1.0 0.6

25 24.2 13.9

41.5 30 18

0.15 0.61 0.76

Anti-emetic use

76.3

71.4

0.8

74.2

70.7

0.8

* **

Clinically important trends. Fishers exact test.

Table 5

Independent predictors of vomiting post surgery.

Variables

Odds ratio

P

[95% Conf. interval]

Beaded Surgery time (min) eGFR (ml/min) BMI (Kg/m2 )

0.31 1.01 1.07 0.89

0.096 0.036 0.046 0.085

0.08 1.00 1.00 0.78

1.23 1.03 1.14 1.02

Backward selection, pr(0.1). Variables removed: QoR Age, Sex, Apfel Score, Smoking status.

post-operative vomiting between groups. Although the pilot recruited around 13 participants a month, given appropriate resources for a multi-site project, including staffing for pre-trial education, screening and data collection it would be reasonable to suggest that recruiting 25—30 participants per month over a period of eighteen months to two years would be feasible for a larger study. Protocol adherence was excellent, suggesting that the intervention is well tolerated and received by patients as well as easy for anaesthetists and nurses to deliver. In addition, given that PC 6 stimulation for PONV is not widely used, a larger study could include an integrated knowledge translation approach, with active engagement of patients/health care professionals, to understand the factors that support, or impede its use to allow for targeted implementation strategies to be developed, should the results of the larger study demonstrate a positive impact. There was some concern regarding the wristbands being too tight, however of the 5 men who requested that the bands be removed all had BMIs below 31 and only one had a wrist circumference close to the cut off. There is a need however for bigger bands given that it is common for patients undergoing cardiac surgery to have BMIs greater than 35 and males to have wrist circumferences greater than 21 cm. We found that blinding was addressed successfully in this pilot. Research and clinical nurses reported that no patient identified a beaded wristband or compromised the blinding during the pilot. Clinical staff were informed about the

Figure 3 Cumulative incidence of antiemetic use at study time-points. This line chart was plotted using Kaplan—Meier survivor functions calculated over the full data and evaluated at indicated times.

importance of maintaining blinding at the outset of the pilot so were clear that they were not to take off the covering over the elastic wristbands or feel for the bead (covering totally obscured both the beaded and non-beaded bands that were made of the same elastic material by the same company, that is, the only difference was the plastic bead incorporated in the wristband that was placed over the PC 6 acupoint). An important consideration in choosing PC 6 acupoint acupressure via the use of wristbands (rather

Wrist acupressure for post-operative nausea and vomiting

Figure 4 Mean nausea score of subjects over time. Most of the scores were zero thus accounting for the low mean values*. *1:beaded; 0:non-beaded

than other methods such as acupuncture, acu-stimulation devices, capsicum plaster, as described in the Cochrane Systematic Review) was to evaluate its clinical feasibility. This pilot found that the application of a beaded wristband was quickly and easily undertaken by registered nurses working in the clinical area (with appropriate training). The pilot demonstrated that up to 60% of post-operative cardiac surgery patients will experience some severity of post-operative nausea and vomiting (PONV) in the first 36 h post-operative. This figure is higher than most of the previously reported incidences, and, thus, justifies the importance of focusing on this high-risk population for a larger study. Although this pilot study did not expect significant results in relation to nausea, vomiting, need for rescue medication and quality of recovery, there was a clinically significant difference for late vomiting (and thus severe nausea) between the beaded and non-beaded groups, and if a larger study confirms the observed effect size of 0.31, this would be highly beneficial for patients. It is not clear why the use of rescue anti-emetics was similar in both groups but the incidence of vomiting in the beaded group was clinically significant especially over time. It may be the combined effect of anti-emetics and PC 6 stimulation or the different mechanisms of effect PC 6 acupoint stimulation may have on nausea and vomiting. A larger study should investigate this further. The cost of a pair of wristbands is minimal, in this pilot the cost was $7/pair and as such there may be value for money in their use that could be assessed in a larger study in relation to: (i) patients’ quality of recovery and prevention of potential complications related to vomiting such as tension on sutures and wounds, imbalances in body electrolytes, and bleeding that could lead to increased length of hospital stay post ICU; (ii) the quality of the post-cardiac surgery experience and benefits of the intervention in relation to PONV from both patient and staff perspectives evaluated through a knowledge translation component; (iii) costs of post-operative anti-emetics (frequency, dose, and route); and, (iv) nurses time/and other resources used in managing PONV, for example, administering treatment, changing linen, disposable resources. The strength of this pilot study was the successful implementation of a rigorous RCT design that took into account

379 concerns raised in the Cochrane Systematic Review11 in relation to allocation sequence generation, allocation concealment, blinding of healthcare providers and lack of assessment of quality of recovery to provide the basis for a larger study. As a pilot study, limitations in staffing resources did impact on feasibility outcomes as recruitment of some potential patients were missed and many patients were excluded as they had anti-emetics or histamine H2 -receptor antagonist within 24 h prior to surgery. However, with appropriate resources for education, recruitment and monitoring a larger funded RCT is feasible. In summary, results from this pilot study provide preliminary support for a non-invasive treatment for PONV, and encourage further testing of the efficacy of PC 6 acupoint stimulation vs. placebo for reducing PONV in cardiac surgery patients through a large full-scale, multisite RCT in order to generate conclusive knowledge for post-operative management and patient care. It would also be prudent in to include an integrated knowledge translation component and an investigation of any value for money gained in using PC 6 stimulation via wristbands.

Conflict of interest The authors report no conflicts of interest to disclose.

Acknowledgements We would like to thank NHMRC Centre for Research Excellence in Nursing Interventions for the funding for this pilot study.

References 1. Australian Institute of Health and Welfare. Australian hospital statistics 2011—2012. Canberra: AIHW; 2013. Contract No.: Health services series no. 50. Cat. no. HSE 134. 2. Australian Institute of Health and Welfare. Australia’s health 2012. Canberra: AIHW; 2012. Contract No.: Australia’s health series no.13. Cat. no. AUS 156. 3. Sawatzky JV, Rivet M, Ariano R, Hiebert B, Arora R. Post-operative nausea and vomiting in the cardiac surgery population: who is at risk? Heart Lung 2014;43:550—4. 4. Bainbridge D, Martin J, Cheng D. Patient-controlled versus nurse-controlled analgesia after cardiac surgery: a metaanalysis. Can J Anesth 2006;53:492—9. 5. Korinenko Y, Vincent A, Cutshall SM, Li Z, Sundt TM. Efficacy of acupuncture in prevention of postoperative nausea in cardiac surgery patients. Ann Thorac Surg 2009;88:537—42. 6. Klien AA, Djaiani G, Karski J, Carroll J, Karkouti K, McCluskey S, et al. Acupressure wristbands for the prevention of postoperative nausea and vomiting in adults undergoing cardiac surgery. J Cardiothorac Vasc Anesth 2004;18:68—71. 7. Choi DK, Chin JH, Lee EH, Lim OB, Chung CH, Ro YJ, et al. Prophylactic control of post-operative nausea and vomiting using ondansetron and ramosetron after cardiac surgery. Acta Anaesthesiol Scand 2010;54:962—9. 8. Gan T. Risk factors for postoperative nausea and vomiting. Anesth Analg 2006;102:1884—98. 9. Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10811 patients. Br J Anaesth 2000;84:6—10.

380 10. Carlise J, Stevenson C. Drugs for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev 2006;(3). Art. No. CD004125. 11. Lee A, Fan L. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev 2009;(2). Art. No. CD003281. 12. Abraham J. Acupressure and acupuncture in preventing and managing postoperative nausea and vomiting in adults. J Perioper Pract 2008;18:543—51. 13. Turgut S, Ozalp G, Dikmen S, Savli S, Tuncel G, Kadiogullari N. Acupressure for postoperative nausea and vomiting in gynaecological patients receiving patient-controlled analgesia. Eur J Anaesthesiol 2007;24:87—91. 14. Sadighha A, Nurai N. Acupressure wristbands versus metoclopramide for the prevention of postoperative nausea and vomiting. Ann Saudi Med 2008;28:287—91. 15. WHO Western Pacific Region Office. Guidelines for clinical research on acupuncture. Manila, Philippines: WHO; 1995. 16. WHO Western Pacific Region Office. WHO standard acupuncture point locations in the Western Pacific Region. Manila, Philippines: WHO; 2008. 17. Arnold DM, Burns KEA, Adhikari NKJ, Kho ME, Meade MO, Cook DJ. The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med 2009;37:s69—74. 18. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307—12.

M. Cooke et al. 19. van-Teijlingen ER, Hundley V. The importance of pilot studies. Soc Res Update 2001;35:289—95. 20. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and ellaboration: updated guidelines for reporting parallel group randomised trials. Br Med J 2010;340:c869. 21. MacPherson H, Li Y, Moher D, Altman DG, Wu T, Hammerschlag R, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Aust J Acupunct Chin Med 2010;5:8—22. 22. Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287—91. 23. Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin 2003;41:13—32. 24. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. West Sussex: John Wiley & Sons; 2009. 25. Apfel CC, Greim CA, Haubitz I, Goepfert C, Usadel J, Sefrin P, et al. A risk score to predict the probability of postoperative vomiting in adults. Acta Anaesthesiol Scand 1998;42: 495—501. 26. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology 2013;118:1332—40. 27. Proschan MA. Two-Stage Sample Size Re-Estimation Based on a Nuisance Parameter: A Review. J Biopharm Stat 2005;5: 559—74.

Wrist acupressure for post-operative nausea and vomiting (WrAP): A pilot study.

Post-operative nausea and vomiting are undesirable complications following anaesthesia and surgery. It is thought that acupressure might prevent nause...
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