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Trial registered on ANZCTR


Registration number
ACTRN12607000585426
Ethics application status
Approved
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
14/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Use of Acupressure Wristbands to Prevent Nausea and Vomiting in Labour and Delivery
Scientific title
A Randomized, Double-Blinded, Sham-Controlled Study to Evaluate the Antiemetic Efficacy of the Pressure Right Acupressure Wristband versus Placebo Bands.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea and Vomiting 2542 0
Condition category
Condition code
Reproductive Health and Childbirth 2642 2642 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupressure Wristbands applied to Nei-Kuan (P 6) acupoint
Bands to be applied from recruitment and kept in situ until 2 hours post delivery.
Intervention code [1] 2274 0
Prevention
Intervention code [2] 2286 0
Prevention
Comparator / control treatment
Sham wristbands
Control group
Placebo

Outcomes
Primary outcome [1] 3552 0
Incidence of Nausea and/or Vomiting
Timepoint [1] 3552 0
During 2 hourly time intervals throughout the study period (start of established labour until two hours after delivery)
Secondary outcome [1] 5941 0
Incidence of Vomiting
Timepoint [1] 5941 0
during 2 hourly time periods of study period
Secondary outcome [2] 5942 0
Episodes of vomiting
Timepoint [2] 5942 0
During study period
Secondary outcome [3] 5943 0
Incidence of nausea
Timepoint [3] 5943 0
During 2 hourly time intervals during study period
Secondary outcome [4] 5944 0
Severity of Nausea - numerical rating scale 0-10
Timepoint [4] 5944 0
During 2 hourly time intervals throughout study period
Secondary outcome [5] 5945 0
Use of Rescue antiemetics
Timepoint [5] 5945 0
during study period
Secondary outcome [6] 5946 0
Maternal Satisfaction with control of nausea assertained from brief interview with mother.
Timepoint [6] 5946 0
2 - 14 hours after delivery
Secondary outcome [7] 5947 0
Inconvenience/discomfort associated with band
Assertained from brief interview with mother
Timepoint [7] 5947 0
2- 14 hours after delivery

Eligibility
Key inclusion criteria
Term Pregnancy>/= 37 gestation
Admitted to delivery and confirmed as in the first stage of labour
American Society of Anaesthesiologists grade 1 and 2
Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body Mass Index > 35
Current use of acupressure techniques or drugs with antiemetic activity
Nausea and vomiting within the previous 6 hours
sensitivity or allergy to adhesive tapes
Pre-term gestation
American Society of Anaesthesiologists grade 3 or 4
Intrauterine death or foetal abnomality
Non-English Speaking
Known intravenous drug user

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)
Each patient eligible will be seen by a member of the research team and given information about the trial verbally and via a patient information sheet. After giving written consent each participant will be allocated a sealed opaque envelope containing two wristbands ( either active or placebo) with instructions on how to apply them - these bands will be applied by the recruiting research team member and covered in a soft bandage to conceal band type from observers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
340 subjects have been randomized in a 1:1 ratio (Active or Placebo) using a computer generated random number sequence and the appropriate band (Active or Placebo) plus application instuctions placed in numbered sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 493 0
6008

Funding & Sponsors
Funding source category [1] 2786 0
Self funded/Unfunded
Name [1] 2786 0
Department of Anaesthetics and Pain Medicine
Country [1] 2786 0
Australia
Funding source category [2] 2787 0
Commercial sector/Industry
Name [2] 2787 0
Therapeutics: 101 Inc
Country [2] 2787 0
United States of America
Primary sponsor type
Hospital
Name
Dr Melanie Thew
Address
Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 2517 0
Hospital
Name [1] 2517 0
Prof. Michael Paech
Address [1] 2517 0
Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for women
374 Bagot Road
Subiaco
WA 6008
Country [1] 2517 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4704 0
King Edward Memorial Hospital for Women Ethics Committee
Ethics committee address [1] 4704 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Ethics committee country [1] 4704 0
Australia
Date submitted for ethics approval [1] 4704 0
Approval date [1] 4704 0
06/11/2007
Ethics approval number [1] 4704 0
1467/EW

Summary
Brief summary
Introduction
Feeling sick in labour is a common problem which can cause additional distress. These symptoms probably occur due to pain, anxiety and drug side effects. We are interested in studying the potential effect of using acupressure wrist bands to stop nausea and vomiting in this setting. This is a non-drug remedy, related to acupuncture, involving applying pressure to a point near the wrist. It has been shown to be successful in combating sickness in other situations such as post-operative nausea and vomiting, and morning sickness.
Aims/Objectives/Hypotheses
The study aims to look at the rates of sickness in women wearing acupressure wristbands (PressureRightTM) compared to baseline levels and those wearing dummy (placebo) bands.
Study Population
We will be studying women who are in good health, aged18 years or older, in full term labour admitted to the labour ward and who consent to taking part in our trial. They will receive information about the project and they will be able to withdraw from the study at any time.
We will not be looking at women who are morbidly obese, known to be intravenous drug users, have an allergy to tapes, have an abnormal or dead baby, do not speak English, and/or are using acupressure techniques or medications to treat nausea already.
Methods
Women who have agreed and signed a written consent will be randomly assigned to one of the two groups, treatment group with the bands applied correctly and placebo group with dummy (placebo) bands. Both types of bands will be covered. We will collect baseline information such as age, weight, height, pregnancy details, smoking status, history of motion sickness, progress of labour, use of medications, presence of initial nausea and pain. Further information will be collected during the labour by way of a simple form (with midwife help). This will include sickness and pain severity. The rest of the required information including the use of any medications during labour, use of an epidural, basic observations such as blood pressure, and the level of satisfaction with their care will be collected post delivery.
Ethical Issues
There are no significant ethical issues in the performance of this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28177 0
Address 28177 0
Country 28177 0
Phone 28177 0
Fax 28177 0
Email 28177 0
Contact person for public queries
Name 11334 0
Prof. M. Paech
Address 11334 0
Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 11334 0
Australia
Phone 11334 0
+61 8 9340 2250
Fax 11334 0
+61 8 9340 2260
Email 11334 0
[email protected]
Contact person for scientific queries
Name 2262 0
Prof. M. Paech
Address 2262 0
Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008
Country 2262 0
Australia
Phone 2262 0
+61 8 9340 2250
Fax 2262 0
+61 8 9340 2260
Email 2262 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

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