Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000589684
Ethics application status
Not yet submitted
Date submitted
28/05/2014
Date registered
4/06/2014
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Wrist Acupressure for Post-operative Nausea and Vomiting: A randomised controlled trial
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
Secondary ID [1] 284681 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
WRAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative nausea and vomiting 292021 0
Condition category
Condition code
Alternative and Complementary Medicine 292367 292367 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in acupressure wristband group will have the Seaband "Registered Trademark" wristband applied on arrival to ICU from surgery to both wrists by a Registered Nurse (bilateral application is recommended) ensuring the bead stimulates the Neiguan (PC6) acupoint. The wristbands are elasticized to encircle the wrist, will be covered with a light opaque covering bandage and will be removed at 36 hours from admission time to ICU after final outcome measurement.
Intervention code [1] 289467 0
Prevention
Comparator / control treatment
Participants in placebo wristband group will have a placebo (sham/without bead) wristband applied to each wrist on arrival to ICU from surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 292224 0
Post-operative nausea and vomiting (PONV). Participants' nausea will be assessed at 6 time points: 6 hours from arrival to the ICU; 12 hours post arrival (to compare with studies using a 6 hour dose as patients will likely be ventilated for first 6 hours); then 4 hourly up to 24 hours; and then at 36 hours on a 10-point numerical scale. All episodes of retching or vomiting in the 36-hour time period will be recorded
Timepoint [1] 292224 0
First 36 hours following admission to Intensive Care Unit post cardiac surgery
Secondary outcome [1] 308468 0
Rescue drug therapy. Rescue antiemetic will be given and recorded for patients who experience mild-severe nausea or an episode of vomiting within the 36-hour study period
Timepoint [1] 308468 0
First 36 hours following admission to Intensive Care Unit post cardiac surgery
Secondary outcome [2] 308472 0
Quality of Recovery (QOR). Participants will self-assess the QOR on the morning of the 4th post-operative day using a 15-item questionnaire – the QOR-15. This instrument asks participants to rate their recovery from ‘0 = none of the time’ to ‘10 = all of the time’ to enable a QOR score as a summary (max score 150), and has evidence of excellent validity and reliability.
Timepoint [2] 308472 0
Morning of day 4 post-operatively
Secondary outcome [3] 308475 0
Costs associated with treatment for PONV. Healthcare resource use related to the management of nausea and vomiting will be assessed and costed. This will include: band use; frequency, dose, route and duration of rescue anti-emetics; length of stay in ICU and length of stay in hospital post ICU; and costs associated with any adverse effects of the PC6 stimulation device.
Timepoint [3] 308475 0
Discharge from hospital
Secondary outcome [4] 308480 0
Patients’ satisfaction with their PONV care. At PC6 stimulation device removal, the RN will ask the patient (if able) about their satisfaction with their PONV care on a 10-point scale (‘0=completely dissatisfied’, ‘10=completely satisfied’).
Timepoint [4] 308480 0
At removal of wristbands 36 hours after application
Secondary outcome [5] 308483 0
Clinical staff's perceptions of clinical use, feasibility, acceptability and challenges of using acupressure wristbands for post-operative nausea and vomiting in practice. Clinical staff will be invited to participate in either group or individual semi-structured interviews about the clinical use, feasibility, acceptability, and challenges in using the acupressure wristbands for PONV in clinical practice, and their trial involvement. Interview schedule will be informed by the Theoretical Domains Framework
Timepoint [5] 308483 0
At 4, 8, and 16th month of recruitment

Eligibility
Key inclusion criteria
Elective + urgent primary cardiac surgery (CABG; valve and double valve replacement; CABG + single valve replacement); able to understand, speak, read and write English; and 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
Exclusion Criteria: Impaired renal function – creatinine level >200 or eGFR<50; patients receiving antiemetic medication within 24-hours prior to surgery, or histamine H2-receptor antagonist within 24-hours prior to surgery; skin damage (e.g. burn scars) over PC6 area; wrist circumference >21cm; emergency cases; radial artery harvest for conduit in CABG; and previous experience of acupressure for nausea and/or vomiting including morning sickness, chemotherapy-related nausea and vomiting and travel sickness.

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)
A Registered Research Nurse (RRN), employed specifically for this project, will identify the elective patients from operation lists and approach each patient (at pre-admission clinic or on ward) to initially explain the study to them. Those interested will then be formally screened by the RRN and those eligible will be provided with an information sheet and contact details of the study manager for further information. Written informed consent will then be obtained. RRN will obtain a participant code number corresponding to a study pack to which each participant will be randomly allocated by a web-based independent automated service at the university Clinical Trials Coordination Centre (CTCC), configured for this trial by a biostatistician, and record study group code in patient’s medical record and on study forms. Computer-generated random assignment will occur at the point of study entry, and each patient will be allocated to a numbered trial group. RRN1 will record the code on patient’s medical record and data collection sheet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
each participant will be randomly allocated by a web-based independent automated service at the university Clinical Trials Coordination Centre (CTCC), configured for this trial by a biostatistician. Randomisation will involve a 1:1 ratio; stratified assignment by risk of nausea (Apfel Score that can be stratified into low [score 0 or 1], moderate [score 2], extremely high [score 3 or 4] and study site, with random variation in block sizes.
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
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
2/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
712
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2510 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 2511 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 8150 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 289305 0
Self funded/Unfunded
Name [1] 289305 0
Pending funding
Country [1] 289305 0
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan Qld 4111
Country
Australia
Secondary sponsor category [1] 287975 0
Hospital
Name [1] 287975 0
The Prince Charles Hospital
Address [1] 287975 0
Rode Road
Chermside, Qld, 4032
Country [1] 287975 0
Australia
Secondary sponsor category [2] 287976 0
Hospital
Name [2] 287976 0
Holy Spirit Northside
Address [2] 287976 0
Rode Road
Chermside, Qld, 4032
Country [2] 287976 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291069 0
Metro North Hospital and Health Service HREC
Ethics committee address [1] 291069 0
Rode Road
Chermside, Qld, 4032
Ethics committee country [1] 291069 0
Australia
Date submitted for ethics approval [1] 291069 0
01/12/2014
Approval date [1] 291069 0
Ethics approval number [1] 291069 0
Ethics committee name [2] 291070 0
Griffith University HREC
Ethics committee address [2] 291070 0
170 Kessels Road
Nathan, Qld, 4111
Ethics committee country [2] 291070 0
Australia
Date submitted for ethics approval [2] 291070 0
02/02/2015
Approval date [2] 291070 0
Ethics approval number [2] 291070 0

Summary
Brief summary
Postoperative nausea and vomiting (PONV) are common unwanted complications for patients following anaesthesia/cardiac surgery, affecting at least 1:3 patients, despite pharmacologic treatment. Patients have a strong preference for avoiding PONV: satisfaction with anaesthetic care and subsequent quality of health care is strongly related to experiences of PONV. Acupressure is one alternative approach thought to prevent nausea and vomiting through an alteration in endorphins and serotonin levels and is an intervention endorsed by the World Health Organisation (WHO). This two-group, parallel, superiority, randomised controlled trial (RCT) will test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48766 0
Prof Marie Cooke
Address 48766 0
170 Kessels Road
N48_2.21
Griffith University
Nathan Qld 4111
Country 48766 0
Australia
Phone 48766 0
61 7 37355253
Fax 48766 0
Email 48766 0
[email protected]
Contact person for public queries
Name 48767 0
Prof Marie Cooke
Address 48767 0
170 Kessels Road
N48_2.21
Griffith University
Nathan Qld 4111
Country 48767 0
Australia
Phone 48767 0
61 7 37355253
Fax 48767 0
Email 48767 0
[email protected]
Contact person for scientific queries
Name 48768 0
Prof Marie Cooke
Address 48768 0
170 Kessels Road
N48_2.21
Griffith University
Nathan Qld 4111
Country 48768 0
Australia
Phone 48768 0
61 7 37355253
Fax 48768 0
Email 48768 0
[email protected]

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Results publications and other study-related documents

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