Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000416796
Ethics application status
Approved
Date submitted
9/04/2013
Date registered
15/04/2013
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Wrist acupressure for post-operative nausea and vomiting: A feasibility study
Scientific title
Wrist acupressure for post-operative nausea and vomiting: a comparison of PC 6 acupoint stimulation versus placebo for reducing postoperative nausea and vomiting in cardiac surgery patients (WRAP Trial)
Secondary ID [1] 282281 0
None
Universal Trial Number (UTN)
U1111-1141-7495
Trial acronym
WRAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative nausea and vomiting in cardiac surgery patients 288817 0
Condition category
Condition code
Alternative and Complementary Medicine 289176 289176 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PC6 acupoint is the meridian point in the pericardium channel and located on the inner forearm between the extensor carpi radialis and palmaris longus tendons one sixth of the distance from PC7 on the medial wrist crease to PC 3 in the cubital fossa (WHO, 2008). Participants in the intervention group (acupressure wristband) will have the Seaband (Registered Trademark) wristbands applied to both wrists ensuring the bead stimulates the Neiguan (PC 6) after establishment of IV access and invasive monitoring in the operating theatre. The wristbands will be covered with opaque bandaging to ensure blinding. The wristbands will be removed at 36 hours from admission time to ICU after final outcome measurement.
Intervention code [1] 286912 0
Prevention
Comparator / control treatment
Participants in the placebo (sham) wristband group will have a sham (without bead) Seaband (Registered Trademark) wristbands applied to both wrists at the position of the Neiguan (PC6) acupoint after establishment of IV access and invasive monitoring in the operating theatre. The wristbands will be covered with opaque bandaging to ensure blinding. The wristbands will be removed at 36 hours from admission time to ICU after final outcome measurement.
Control group
Placebo

Outcomes
Primary outcome [1] 289287 0
Evaluate the feasibility of launching a full-scale multisite efficacy trial, using pre-defined feasibility criteria for recruitment, retention, protocol fidelity and use the pilot data to refine the protocol
Timepoint [1] 289287 0
Outcome assessed when the whole trial is completed, that is when the last participant has completed the final nausea and vomiting outcomes measures at 36 hours and the morning of day 3 Quality of Recovery outcome measure
Primary outcome [2] 289288 0
Patients in the acupressure group will experience less nausea and vomiting postoperatively compared with patients in the sham group. This will be assessed 6 hours from arrival to the ICU, at 8 hours post arrival, 4 hourly up to 24 hours and then at 36 hours on a bedside Case Report Form. Nausea will be assessed on a 10 point scale (“0 = no nausea” to “10 = severe nausea”). For vomiting, all episodes of retching or vomiting in the 36 hour time period will be recorded on the bedside Case Report Form.
Timepoint [2] 289288 0
Will be assessed 6 hours from arrival to the ICU, at 8 hours post arrival, 4 hourly up to 24 hours and then at 36 hours.
Secondary outcome [1] 302168 0
Costs associated with PC 6 stimulation device, costs of antiemetic medication and hospital length of stay in the two groups will be assessed.
Timepoint [1] 302168 0
The cost evaluation of the 2 groups will be assessed at the completion of the trial - ie, when the final participant has completed the last outcome measures for nausea and vomiting at 36 hours post-operatively and Quality of Recovery at day 3.
Secondary outcome [2] 302199 0
Patients in the acupressure group will have a greater quality of recovery at morning of day 3 than patients in the sham group. Participants will self assess the quality of the recovery on the morning of the 3rd postoperative day using a 15 item questionnaire (QOR15; Stark et al., in press).
Timepoint [2] 302199 0
Morning of day 3 post-operative.
Secondary outcome [3] 302200 0
Explore the different treatment arms in relation to dose effect at 8, 24 and 36 hours post application of the wristbands.
Timepoint [3] 302200 0
Will be assessed at the completion of the trial when the last participant has completed all nausea and vomiting outcome measures to 36 hours post-operatively.
Secondary outcome [4] 302201 0
Explore the different treatment arms in relation to the effect on severe nausea
Timepoint [4] 302201 0
Will be assessed at the completion of the trial when the last participant has completed all post-operative nausea and vomiting outcome measures to 36 hours.
Secondary outcome [5] 302202 0
Explore the different arms in relation to the need for rescue drug therapy. Participants need for rescue medication will be recorded on the bedside Case Report Form.
Timepoint [5] 302202 0
Will be assessed at the completion of the trial when the last participant's need for rescue medication has bee recorded at 36 hours post-operative.

Eligibility
Key inclusion criteria
- Elective and urgent primary cardiac surgery (CABG; valve and double valve replacement; CABG + single valve replacement
- Able to understand, speak, read and write English
- Over 18 years of age and able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Add in wrist circumference>21cm.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated allocation provided by independent automated service at the Griffith University Clinical Trials Coordination Centre (CTCC). Allocation is concealed until the patient is randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Placebo device will be used
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be conducted using Stata/SPSS. The Intention To Treat (ITT) principle will be used for all analyses. Descriptive statistics will be reported using appropriate measures of spread and locations to answer the feasibility questions. Differences between study groups of incidence of nausea and vomiting, measured regularly over the first 36 hours, will be analysed using repeated measures logistic regression with either generalized linear models (GenLin) or generalized estimating equations (GEE). Potential confounders (mixed effects) will be identified and differences adjusted for within the models. Nausea severity will use repeated measures general linear models (GLM), whilst other nontemporal outcomes (e.g., usage of rescue therapy and quality of recovery) will use multivariate logistic regression and linear regression models. Due to the sample size (N = 80 - 100), statistical significance is not expected to be found, yet general trends will provide preliminary data to provide support for a large scale RCT. For all statistical comparisons, a significance level of p=0.05 will be employed.). The aim is to establish protocol fidelity and data will be recorded at each assessment of nausea regarding whether wristbands are correctly positioned; and data will be collected in relation to patients lost to follow up and missing data. The feasibility of placing the wristbands on patients after establishment of IV access and invasive monitoring in the operating theatre will be established through interviews with staff.

As sample size of 40 per group (n = 80 in total) has been determined. As this is a feasibility study the sample size was based on Hertzog's (Considerations in Determining
Sample Size for Pilot Studies, Research in Nursing & Health, 2008, 31, 180–191) estimations for efficacy studies that argues that a sample size of 40 per group will provide appropriate power for a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
20/11/2013
Date of last participant enrolment
Anticipated
Actual
5/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 854 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 287051 0
University
Name [1] 287051 0
Griffith University
Country [1] 287051 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus, 170 Kessels Road, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 285832 0
Hospital
Name [1] 285832 0
The Prince Charles Hospital
Address [1] 285832 0
Rode Road, Chermside, Brisbane, QLD, 4032
Country [1] 285832 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289081 0
The Prince Charles Hospital
Ethics committee address [1] 289081 0
Rode Road, Chermside, Brisbane, QLD, 4032
Ethics committee country [1] 289081 0
Australia
Date submitted for ethics approval [1] 289081 0
21/12/2012
Approval date [1] 289081 0
12/02/2013
Ethics approval number [1] 289081 0

Summary
Brief summary
Post-operative nausea and vomiting (PONV) are unwanted complications following anaesthesia and surgery. The occurrence of PONV ranges from 20% to 80%, despite optimal pharmacologic interventions. The burden of caring for patients post cardiac surgery in healthcare system world-wide is immense. In 2009-2010, In Australia alone, over 230,000 cardiac procedures were performed, and the number and rate of cardiac procedures are increasing. Similar to many countries world-wide, cardiovascular disease (CVD) remains the most expensive disease group in Australia, costing about $5.9 billion in 2004–05 with just over half of this money spent on patients admitted to hospital. As part of their illness treatment and recovery, cardiac surgery patients experience varying rates of PONV; studies across various populations have reported rates ranging from 22% to 50%.
Trial website
Trial related presentations / publications
In press Journal article
Cooke M, et al. Wrist acupressure for post-operative nausea and vomiting (WrAP): A pilot study. Complement Ther Med (2015), http://dx.doi.org/10.1016/j.ctim.2015.03.007
Public notes

Contacts
Principal investigator
Name 39134 0
Prof Marie Cooke
Address 39134 0
Griffith University 170 Kessels Road, Nathan Qld 4111
Country 39134 0
Australia
Phone 39134 0
+61 37355253
Fax 39134 0
+61 7 3735 3560
Email 39134 0
[email protected]
Contact person for public queries
Name 39135 0
Prof Marie Cooke
Address 39135 0
Griffith University 170 Kessels Road, Nathan Qld 4111
Country 39135 0
Australia
Phone 39135 0
+61 7 37355253
Fax 39135 0
+61 7 3735 3560
Email 39135 0
[email protected]
Contact person for scientific queries
Name 39136 0
Prof Marie Cooke
Address 39136 0
Griffith Universtiy 170 Kessels Road, Nathan QLD 4111
Country 39136 0
Australia
Phone 39136 0
+61 7 3735 7985
Fax 39136 0
+61 7 3735 3560
Email 39136 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWrist acupressure for post-operative nausea and vomiting (WrAP): A pilot study.2015https://dx.doi.org/10.1016/j.ctim.2015.03.007
N.B. These documents automatically identified may not have been verified by the study sponsor.