Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000419561
Ethics application status
Not yet submitted
Date submitted
24/08/2006
Date registered
29/09/2006
Date last updated
29/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Utility of acupressure bracelets for the reduction of nausea and vomiting in Emergency Department patients. A Prospective Randomised Controlled Trial
Scientific title
Utility of acupressure bracelets for the reduction of nausea and vomiting in Emergency Department patients. A Prospective Randomised Controlled Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and Vomiting (all causes) 1388 0
Condition category
Condition code
Other 1482 1482 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupressure Bracelet(s)
Study intervention: Two proprietary elastic bracelets containing plastic studs (Sea Bands). Device applied such that stud applies pressure over p6 (Neugian) Acupressure point ) situated 3 fingers breadth proximal to the wrist crease between the flexor tendons flexor carpi radialis and palmaris longus.

A third group will not be fitted with any device.
The device will be worn for 90 minutes during the data collection phase. After this period patients continued use of the device will be at the discretion of the treating doctor and the patient.
Intervention code [1] 1263 0
Treatment: Devices
Comparator / control treatment
Control Intervention: Identical device applied such that stud applies pressure over a point three fingers breadth proximal to the flexor crease of the wrist but lateral to the flexor tendons of the forearm.
Control group
Active

Outcomes
Primary outcome [1] 2053 0
Reduction in Nausea score measured using Likert scale (0-6)
Timepoint [1] 2053 0
Measured immediately following enrollment (0mins) at 30 minutes, 60 minutes and at 90 minutes.
Secondary outcome [1] 3539 0
Cessation in vomiting
Timepoint [1] 3539 0
Measured as time from enrollment to cessation of last witnessed vomiting episode (minutes).
Secondary outcome [2] 3540 0
Time to Emergency Department Discharge (hrs and minutes) from time of enrollment in trial to time patient formally discharged from Department as noted on data collection sheet and/ or department computer database.
Note: Total time in department (from time of presentation to department to time of discharge may be looked at as a secondary outcome using data from the department database.)
Timepoint [2] 3540 0
Secondary outcome [3] 3541 0
Admission rates.
Timepoint [3] 3541 0
Recorded either at time of discharge or decision to admit patient.
Secondary outcome [4] 3542 0
Patient Satisfaction.
Timepoint [4] 3542 0
Recorded at time of collection of Nausea score (90 minutes.)
Secondary outcome [5] 3543 0
Cost.
Timepoint [5] 3543 0
Will be estimated post hoc.

Eligibility
Key inclusion criteria
All patients presenting to Emergency Department withSymptoms of Nausea and/ or vomiting will be considered for enrollment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Altered Conscious StateAbnormal Vital SignsTrauma PresentationCommunication Difficulty.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects randomised to receive either the active or sham device will not be informed as to their allocation. The device, packaging and format of instructions will be identical for both groups. The content of instructions will differ. The clinicians responsible for the patient (mostly nursing staff) who will also act as data collectors and be blinded to the allocation. It is acknowledged that there are significant limitations to the degree of blinding possible in this trial.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1620 0
Hospital
Name [1] 1620 0
Angliss Hospital, Eastern Health
Country [1] 1620 0
Australia
Primary sponsor type
Government body
Name
Eastern Health Network
Address
Country
Australia
Secondary sponsor category [1] 1421 0
Hospital
Name [1] 1421 0
Angliss Hospital Department of Emergency Medicine
Address [1] 1421 0
Country [1] 1421 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3068 0
Eastern Health Ethics Committee
Ethics committee address [1] 3068 0
Ethics committee country [1] 3068 0
Australia
Date submitted for ethics approval [1] 3068 0
Approval date [1] 3068 0
Ethics approval number [1] 3068 0

Summary
Brief summary
Nausea and vomiting are symptoms frequently reported by patients attending Emergency Departments (EDs).We aim to determine if Acupressure is useful for reducing nausea and vomiting experienced by patients presenting to the Emergency Department. Acupressure is a non-invasive variation of the traditional Chinese Medicine Modality of Acupuncture. To date no studies have been performed in an Emergency Department. Conclusions from previous studies of acupressure in other settings have had mixed results. These studies all suggest that acupressure wristbands are safe and easy to apply.
Our hypothesis is that the use of Acupressure bracelets will lead to a clinically significant reduction in nausea experienced by Emergency Department patients. Our secondary hypothesis is that Sham acupressure (placebo) may provide a similar clinically significant benefit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35667 0
Address 35667 0
Country 35667 0
Phone 35667 0
Fax 35667 0
Email 35667 0
Contact person for public queries
Name 10452 0
Dr Peter Jordan
Address 10452 0
Emergency Department
Angliss Hospital
Upper Frentree Gully VIC 3152
Country 10452 0
Australia
Phone 10452 0
+61 3 97591940
Fax 10452 0
+61 3 97591930
Email 10452 0
peter.jordan @easternhealth.org.au
Contact person for scientific queries
Name 1380 0
Dr Peter Jordan
Address 1380 0
Emergency Department
Angliss Hospital
Upper Ferntree Gully VIC 3152
Country 1380 0
Australia
Phone 1380 0
+61 3 97591940
Fax 1380 0
+61 3 97591930
Email 1380 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
No additional documents have been identified.