Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000223134
Ethics application status
Approved
Date submitted
9/02/2019
Date registered
14/02/2019
Date last updated
21/02/2019
Date data sharing statement initially provided
14/02/2019
Date results provided
14/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of acupressure for post-operative nausea and vomiting
Scientific title
Feasibility of acupressure for post-operative nausea and vomiting: A pilot study utilising the FAME approach
Secondary ID [1] 297345 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post-operative nasuea 311461 0
Postoperative vomiting 311462 0
Post-operative pain 311555 0
Condition category
Condition code
Anaesthesiology 310100 310100 0 0
Other anaesthesiology
Alternative and Complementary Medicine 310101 310101 0 0
Other alternative and complementary medicine
Anaesthesiology 310102 310102 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A combined acupressure interventions consisting of Wristband and auricular acupressure
Wristband (Sea-Band Limited, Leicestershire, England). An elasticised fabric band with a protruding button applies pressure to Nei Guan PC6; an acupuncture point known to reduce nausea and vomiting. This is applied to both wrists prior to surgery and retained in place for 24 hours.
Auricular acupressure using seeds (Earseeds com Inc. NJ, 07666 USA). 4 ear seeds are taped to ear acupuncture points related to the reduction of nausea, vomiting, pain and anxiety on one ear, prior to surgery, and retained in place for 72 hours, with the patient applying manual pressure to the seeds 3 times daily. The points are Shen men, Point Zero, Lung and Subcortex. The choice of those points was based on published clinical trials.
All participants will receive the same standardised acupressure intervention in conjunction with usual anaesthetic and perisurgical care.
Compliance was monitored by the researchers who followed up with patients in person while patients were in the hospital and with phone calls after patients being discharged.
Intervention code [1] 313593 0
Treatment: Devices
Intervention code [2] 313621 0
Treatment: Other
Comparator / control treatment
Standard postoperative nausea and vomiting (PONV ) management of a previous cohort of elective surgery patients from 12/05/2016 to 31/08/2016.
Control group
Historical

Outcomes
Primary outcome [1] 318996 0
FAME framework is used
Feasibility: What is the time commitment required to deliver acupressure within the peri-surgical environment
This is assessed by the trial acupuncturists who recoded the time needed for the procesure
Timepoint [1] 318996 0
During the preoperative period between admission and surgery, assessed by measuring the time taken to deliver acupressure to patients.
Primary outcome [2] 318997 0
Appropriateness:
Of those patients who had acupressure applied preoperatively, the percentage who used acupressure for 24 hours after surgery.
Timepoint [2] 318997 0
24 hours after surgery, assessed by direct observation and questions to the patient.
Primary outcome [3] 318998 0
Meaningfulness: Patient satisfaction with the use of acupressure, assessed by level of agreement with the statement "I am satisfied with the use of acupressure for my recovery" (Strongly agree / agree / neutral / disagree / strongly disagree).
Timepoint [3] 318998 0
24 hours after surgery
Secondary outcome [1] 366690 0
Effectiveness: Incidence of postoperative nausea and vomiting
Timepoint [1] 366690 0
6, 24, 48 and 72 hours after surgery, Assessed by direct questioning of the patient.
Secondary outcome [2] 366691 0
Requirement for rescue antiemetics
Timepoint [2] 366691 0
6, 24, 48 and 72 hours after surgery, assessed by antiemetic medications recorded in the patient medication chart.
Secondary outcome [3] 366692 0
Adverse events occurring during acupressure, including tightness, discomfort, pain, swelling and numbness.
Timepoint [3] 366692 0
24 hours after the operation, direct questioning of the patient.,
Secondary outcome [4] 366693 0
Quality of recovery: QoR-15 questionnaire
Timepoint [4] 366693 0
24 hours after minor surgery or 72 hours after major surgery

Eligibility
Key inclusion criteria
1. Adults 18-90 undergoing elective surgery
2. PONV risk factor at 2 or over,
3. Able to give informed consent
4. For patients whose English is not sufficient for daily communication, interpreting service is required. Only those for whom we can locate an interpreter for the consent will be included.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. PC6 wrist area, or the auricle of the ear, not accessible for any reason including previous trauma, local infection or inflammation, or the need for medical/surgical access.
2. Active carpel tunnel syndrome
3. Participants who find the wristbands painful when wearing them, or if the wristbands constrict their circulation, will be excluded.
4. Participants who develop emergency surgical complications may be discontinued. Standard medical care will take precedence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a feasibility study. The primary outcome is not the clinical outcome, but the data related to the possibility of acupressure being used in the peri-operative setting.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The end points are feasibility and safety.
For feasibility, appropriateness, meaningfulness and safety: descriptive methods will be used.
For effectiveness: Chi square analysis is used to compare the incidence of PONV between the acupressure cohort with the historical cohort. T-tests are used to compare parametric data, including dose of anti-emetics, opioid medication, severity of pain and QR-15.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2016
Date of last participant enrolment
Anticipated
Actual
5/04/2017
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
80
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13078 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 25586 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 301908 0
Government body
Name [1] 301908 0
NHMRC
Country [1] 301908 0
Australia
Funding source category [2] 301909 0
University
Name [2] 301909 0
RMIT University
Country [2] 301909 0
Australia
Primary sponsor type
Hospital
Name
Northern Hospital
Address
: 185 Cooper St, Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 301663 0
Commercial sector/Industry
Name [1] 301663 0
Sea-Band Limited, Leicestershire, England
Address [1] 301663 0
Sea-Band Ltd, Lancaster Road, Hinckley,
Leicestershire, LE10 0AW England
Country [1] 301663 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302596 0
Northern Health
Ethics committee address [1] 302596 0
Ethics committee country [1] 302596 0
Australia
Date submitted for ethics approval [1] 302596 0
16/05/2016
Approval date [1] 302596 0
08/09/2016
Ethics approval number [1] 302596 0
HREC/15/NH/71
Ethics committee name [2] 302597 0
Austin Health
Ethics committee address [2] 302597 0
Ethics committee country [2] 302597 0
Australia
Date submitted for ethics approval [2] 302597 0
06/12/2016
Approval date [2] 302597 0
06/12/2016
Ethics approval number [2] 302597 0
HREC/16/Austin/517

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90766 0
Ms Wanda Stelmach
Address 90766 0
Divisional Director, Surgery
Northern Health
185 Cooper Street
EPPING VIC 3076
Country 90766 0
Australia
Phone 90766 0
+61 3 8405 8814
Fax 90766 0
+61 3 8405 8038
Email 90766 0
[email protected]
Contact person for public queries
Name 90767 0
Zhen Zheng
Address 90767 0
School of Health and Biomedical Sciences
RMIT University
PO BOX 71, Bundoora, Vic 3083, Australia
Country 90767 0
Australia
Phone 90767 0
+61 3 9925 7167
Fax 90767 0
+61 39925 7178
Email 90767 0
[email protected]
Contact person for scientific queries
Name 90768 0
Zhen Zheng
Address 90768 0
School of Health and Biomedical Sciences
RMIT University
PO BOX 71, Bundoora, Vic 3083, Australia
Country 90768 0
Australia
Phone 90768 0
+61 3 9925 7167
Fax 90768 0
+61 3 9925 7178
Email 90768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of the clinical outcomes: incidence of postoperative nausea and vomiting, postoperative pain, use of antiemetics and use of opioids and other surgical related outcomes: duration of the anaesthetise, category of surgery, length of hospital stay
When will data be available (start and end dates)?
Immediately following publication
ending 5 years following main results publication
Available to whom?
To researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Access subject to approvals by Principal Investigator


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
No additional documents have been identified.