Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
297223
0
None
Query!
Universal Trial Number (UTN)
N/A
Query!
Trial acronym
N/A
Query!
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.
Query!
Health condition
Health condition(s) or problem(s) studied:
Postoperative nausea and vomiting
311286
0
Query!
Condition category
Condition code
Anaesthesiology
309900
309900
0
0
Query!
Other anaesthesiology
Query!
Alternative and Complementary Medicine
310136
310136
0
0
Query!
Other alternative and complementary medicine
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
313478
0
Treatment: Other
Query!
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).
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
318844
0
Query!
Timepoint [1]
318844
0
On the day of the surgery
Query!
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.
Query!
Assessment method [2]
318845
0
Query!
Timepoint [2]
318845
0
On the day of the surgery
Query!
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
Query!
Assessment method [3]
319028
0
Query!
Timepoint [3]
319028
0
On the day of the surgery
Query!
Secondary outcome [1]
366221
0
use of rescue anti-emetic medications
Auditing, i.e., data linkage to patient medical records.
Query!
Assessment method [1]
366221
0
Query!
Timepoint [1]
366221
0
within the recovery unit, and 24 hours post-operatively
Query!
Secondary outcome [2]
366222
0
time spent in the recovery unit,
Auditing, i.e., data linkage to patient medical records.
Query!
Assessment method [2]
366222
0
Query!
Timepoint [2]
366222
0
when patient is discharged from the recovery unit
Query!
Secondary outcome [3]
366223
0
duration of hospital stay,
Auditing, i.e., data linkage to patient medical records.
Query!
Assessment method [3]
366223
0
Query!
Timepoint [3]
366223
0
At the end of hospital stay
Query!
Secondary outcome [4]
366224
0
dose of opioid medications
Auditing, i.e., data linkage to patient medical records.
Query!
Assessment method [4]
366224
0
Query!
Timepoint [4]
366224
0
within the first 24 hours post-operatively
Query!
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
Query!
Assessment method [5]
366651
0
Query!
Timepoint [5]
366651
0
first 24 hours post-operatively
Query!
Eligibility
Key inclusion criteria
Inclusion: meeting both criteria
• Those who undergo general anaesthesia
• PONV risk at or more than 2 prior to surgery
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
This is an implementation study, therefore data are compared with historical data in some outmeasures,
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2017
Query!
Date of last participant enrolment
Anticipated
31/10/2019
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2019
Query!
Actual
Query!
Sample size
Target
1292
Query!
Accrual to date
437
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
12993
0
The Northern Hospital - Epping
Query!
Recruitment hospital [2]
13244
0
Broadmeadows Health Service - Broadmeadows
Query!
Recruitment postcode(s) [1]
25476
0
3076 - Epping
Query!
Recruitment postcode(s) [2]
25803
0
3047 - Broadmeadows
Query!
Funding & Sponsors
Funding source category [1]
301771
0
Government body
Query!
Name [1]
301771
0
NHMRC
Query!
Address [1]
301771
0
16 Marcus Clarke St,
Canberra ACT 2601
Query!
Country [1]
301771
0
Australia
Query!
Funding source category [2]
301773
0
University
Query!
Name [2]
301773
0
RMIT University
Query!
Address [2]
301773
0
PO BOX 71,
264 Plenty Road, Bundoora
Victoria 3083
Query!
Country [2]
301773
0
Australia
Query!
Funding source category [3]
301931
0
Commercial sector/Industry
Query!
Name [3]
301931
0
Seaband Ltd
Query!
Address [3]
301931
0
Hawley Road, Hinckley, Leicestershire, LE10 0PR.
Query!
Country [3]
301931
0
United Kingdom
Query!
Primary sponsor type
Hospital
Query!
Name
Northern Hospital
Query!
Address
185 Cooper St, Epping VIC 3076
Query!
Country
Australia
Query!
Secondary sponsor category [1]
301516
0
Commercial sector/Industry
Query!
Name [1]
301516
0
Seaband Ltd
Query!
Address [1]
301516
0
Hawley Road, Hinckley, Leicestershire, LE10 0PR.
Query!
Country [1]
301516
0
United Kingdom
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
302489
0
Austin Health Human Research Ethics Committee
Query!
Ethics committee address [1]
302489
0
145 Studley Rd, Heidelberg VIC 3084
Query!
Ethics committee country [1]
302489
0
Australia
Query!
Date submitted for ethics approval [1]
302489
0
18/05/2016
Query!
Approval date [1]
302489
0
08/12/2016
Query!
Ethics approval number [1]
302489
0
HREC/16/Austin/517
Query!
Ethics committee name [2]
302492
0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Query!
Ethics committee address [2]
302492
0
124 La Trobe St, Melbourne VIC 3000
Query!
Ethics committee country [2]
302492
0
Australia
Query!
Date submitted for ethics approval [2]
302492
0
07/04/2017
Query!
Approval date [2]
302492
0
21/06/2017
Query!
Ethics approval number [2]
302492
0
ND 16/517
Query!
Summary
Brief summary
About one in two to three surgical patients suffer from nausea and vomiting after operation
(PONV) and PONV greatly impacts on patient surgical experience and can prolong the hospital stay. Acupressure, a form of non-invasive acupuncture, can safely and effectively reduce the incidence of PONV by up to 30%.
The current project aims to assess if acupressure could be incorporated into the routine management of PONV in a public hospital in Victoria to provide a non-drug option for surgical patients; what factors may impact on the adoption of acupressure; and if this non-drug option could reduce PONV and / or the use of medications. The acupressure tested is a wristband, called Seaband, and is applied to Nei Guan, an acupuncture point on the wrist of patient, about 30 min prior to surgery. The band can be in place for 24 hours. The band can be easily removed by patient if it becomes uncomfortable and can be applied later.
We expect to see that this band can be easily integrated into the standard PONV management plan, and acupressure may reduce PONV or the use of anti-emetics post-operatively. Both staff and patients would be happy to have a non-drug option to complement the existing PONV management plan.
Query!
Trial website
N/A
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
90398
0
Ms Wanda Stelmach
Query!
Address
90398
0
Divisional Director, Surgery
Northern Health
185 Cooper Street EPPING VIC 3076
Query!
Country
90398
0
Australia
Query!
Phone
90398
0
+61 3 8405 8814
Query!
Fax
90398
0
+61 3 8405 8038
Query!
Email
90398
0
[email protected]
Query!
Contact person for public queries
Name
90399
0
A/Prof Zhen Zheng
Query!
Address
90399
0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora, Vic 3083
Query!
Country
90399
0
Australia
Query!
Phone
90399
0
+61 3 9925 7167
Query!
Fax
90399
0
+61 3 9925 7178
Query!
Email
90399
0
[email protected]
Query!
Contact person for scientific queries
Name
90400
0
A/Prof Zhen Zheng
Query!
Address
90400
0
School of Health and Biomedical Sciences
RMIT University
PO Box 71
Bundoora, Vic 3083
Query!
Country
90400
0
Australia
Query!
Phone
90400
0
+61 3 9925 7167
Query!
Fax
90400
0
+61 3 9925 7178
Query!
Email
90400
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
The study is mainly based on audit.
Query!
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.
Download to PDF