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Trial registered on ANZCTR


Registration number
ACTRN12619000333112
Ethics application status
Approved
Date submitted
8/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the update of acupressure in the management of post-operative nausea and vomiting through auditing
Scientific title
Evaluating the implementation of acupressure as part of the management of post-operative nausea and vomiting among surgical patients undergoing general anaesthesia: an audit
Secondary ID [1] 297223 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
"Feasibility of acupressure for post-operative nausea and vomiting" ACTRN12619000223134. is a sub-study of this project. It provides feasibility data to this implementation project.

Health condition
Health condition(s) or problem(s) studied:
Postoperative nausea and vomiting 311286 0
Condition category
Condition code
Anaesthesiology 309900 309900 0 0
Other anaesthesiology
Alternative and Complementary Medicine 310136 310136 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupressure wristband (Seaband) is implemented. The suitable intervention has been determined through a feasibility study. Acupressure is applied to prospectively patients who are considered at a moderate to high risk for postoperative nausea and vomiting (PONV) as assessed with a PONV risk checklist and who agree to use acupressure.

Nurses at the pre-admission clinic applies one SeaBand to PC6 (Neiguan, an acupuncture point) on the right side of the wrist 30 minutes prior to the operation. The wristband is to be left on 24 hours postoperatively. The wristband will feel firm around the wrist, but not so tight that they are painful or constricting. Patients are advised to press on the button that is on the band if they feel nausea or want to vomit. Patients are notified if the wristband becomes too tight or very uncomfortable, it can be taken off for 30 min for a break or not use them thereafter. It is normal to see a red mark or indentation afterwards. Time of application will be noted on the Sea-Band and documented in the patient’s Progress Notes.
The observation time is 24 hours.
Intervention code [1] 313478 0
Treatment: Other
Comparator / control treatment
Standard treatment protocol for PONV at the hospital site is prescribed by anaesthetists. It is advised the PONV risk is assessed and prophylaxis, such as dexamethasone is given after induction to suitable patients. PONV protocol is prescribed by anaesthetists. If patient experiences PONV in the recovery unit, a standard protocol consisting of three types of anti-emetics (Ondansetron 4mg IV, Droperidol 0.625mg IV, Cyclizinee 25mg slow IV) will be administered by nurses. The medications will be given one after another only if PONV persists.
For implementation outcomes: the comparator is the data in 2016 prior to implementation; and the data in each month during and post implementation from 2017-2018.
For clinical outcomes: The comparator is those patients who do not want to use acupressure band and receive the standard treatment protocol for PONV at the hospital site during and post-implementation (2017 and 2018).
Control group
Active

Outcomes
Primary outcome [1] 318844 0

PONV risk self-checklist is completed for or by surgical patients who undergoing general anaesthesia.
This is through auditing the use and completion of PONV checklist, i e. data linkage to patient medical records.
Timepoint [1] 318844 0
On the day of the surgery
Primary outcome [2] 318845 0
Performance of acupressure is recorded
This is though auditing the Anaesthetics Chart “Progress note”, and “pre-operative checklist” and “post-operative” checklist, i.e., data linkage to patient medical records.
Timepoint [2] 318845 0
On the day of the surgery
Primary outcome [3] 319028 0
Expression of interest (EOI) for acupressure is given by surgical patients who undergoing general anaesthesia.
This is through auditing the use and completion of PONV checklist of EOI in patient medical records
Timepoint [3] 319028 0
On the day of the surgery
Secondary outcome [1] 366221 0
use of rescue anti-emetic medications
Auditing, i.e., data linkage to patient medical records.
Timepoint [1] 366221 0
within the recovery unit, and 24 hours post-operatively
Secondary outcome [2] 366222 0
time spent in the recovery unit,
Auditing, i.e., data linkage to patient medical records.
Timepoint [2] 366222 0
when patient is discharged from the recovery unit
Secondary outcome [3] 366223 0
duration of hospital stay,
Auditing, i.e., data linkage to patient medical records.
Timepoint [3] 366223 0
At the end of hospital stay
Secondary outcome [4] 366224 0
dose of opioid medications
Auditing, i.e., data linkage to patient medical records.
Timepoint [4] 366224 0
within the first 24 hours post-operatively
Secondary outcome [5] 366651 0
the incidence of PONV (For short-stay and day cases only)
Through follow up with patients via phone calls or a survey sent to patients via their smart phone
Timepoint [5] 366651 0
first 24 hours post-operatively

Eligibility
Key inclusion criteria
Inclusion: meeting both criteria
• Those who undergo general anaesthesia
• PONV risk at or more than 2 prior to surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: meeting anyone of the following criteria
• Patients that are scheduled to stay in Intensive Care Unit after surgery;
• Patients have active carpel tunnel syndrome
• Patients whose wrist is over 23 cm in circumference or
• Patient wrist is swelling or in pain

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is an implementation study, therefore data are compared with historical data in some outmeasures,
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Audit data of implementation outcome will be presented as percentage of compliance against each criterion.

For all cases, the clinical outcome data will be compared between those who use and those who do not use acupressure wristband during the same time period.

Independent t-tests will be used for continuous data, and chi-square analysis will be used for categorical data with. Bonferroni correction. Data will be collected and analysed by independent personnel who are not involved in delivering acupressure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
1292
Accrual to date
437
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12993 0
The Northern Hospital - Epping
Recruitment hospital [2] 13244 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 25476 0
3076 - Epping
Recruitment postcode(s) [2] 25803 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 301771 0
Government body
Name [1] 301771 0
NHMRC
Country [1] 301771 0
Australia
Funding source category [2] 301773 0
University
Name [2] 301773 0
RMIT University
Country [2] 301773 0
Australia
Funding source category [3] 301931 0
Commercial sector/Industry
Name [3] 301931 0
Seaband Ltd
Country [3] 301931 0
United Kingdom
Primary sponsor type
Hospital
Name
Northern Hospital
Address
185 Cooper St, Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 301516 0
Commercial sector/Industry
Name [1] 301516 0
Seaband Ltd
Address [1] 301516 0
Hawley Road, Hinckley, Leicestershire, LE10 0PR.
Country [1] 301516 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302489 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302489 0
Ethics committee country [1] 302489 0
Australia
Date submitted for ethics approval [1] 302489 0
18/05/2016
Approval date [1] 302489 0
08/12/2016
Ethics approval number [1] 302489 0
HREC/16/Austin/517
Ethics committee name [2] 302492 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [2] 302492 0
Ethics committee country [2] 302492 0
Australia
Date submitted for ethics approval [2] 302492 0
07/04/2017
Approval date [2] 302492 0
21/06/2017
Ethics approval number [2] 302492 0
ND 16/517

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

Contacts
Principal investigator
Name 90398 0
Ms Wanda Stelmach
Address 90398 0
Divisional Director, Surgery
Northern Health
185 Cooper Street EPPING VIC 3076
Country 90398 0
Australia
Phone 90398 0
+61 3 8405 8814
Fax 90398 0
+61 3 8405 8038
Email 90398 0
wanda.stelmach@nh.org.au
Contact person for public queries
Name 90399 0
Zhen Zheng
Address 90399 0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora, Vic 3083
Country 90399 0
Australia
Phone 90399 0
+61 3 9925 7167
Fax 90399 0
+61 3 9925 7178
Email 90399 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 90400 0
Zhen Zheng
Address 90400 0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora, Vic 3083
Country 90400 0
Australia
Phone 90400 0
+61 3 9925 7167
Fax 90400 0
+61 3 9925 7178
Email 90400 0
zhen.zheng@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is mainly based on audit.


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.