- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00275483
Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure
May 27, 2008 updated by: Herlev Hospital
Prevention of PONV by Acupressure. A Study of the Effect of a Recently Generated Danish Bracelet Vital-Band(R) Which Stimulates the Acupressure Point P6
The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Herlev
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Copenhagen, Herlev, Denmark, 2730
- Herlev University Hospital, department of anaestesiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female,
- Non-smoker,
- >18 years,
- ASA 1 or 2,
- Signed patient information,
- IV-anaestesia.
Exclusion Criteria:
- Male,
- Smoker,
- ASA 3 or 4,
- Pregnancy,
- Nausea and vomiting within the last 24 h before operation,
- Diabetes,
- Carpaltunnel syndrome,
- Lymphedema of arms,
- Eczema of forearm,
- Patients who earlier has undergone removal of lymph nodes in the armpits,
- Inhalation anaestesia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Postoperative nausea and vomiting
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Secondary Outcome Measures
Outcome Measure |
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1: The use of conventionel antiemetic treatment.
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2: Lenght of stay in the perioperative unit.
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3: overall lenght of stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Birgitte Majholm, MD, Herlev Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
January 10, 2006
First Submitted That Met QC Criteria
January 10, 2006
First Posted (Estimate)
January 12, 2006
Study Record Updates
Last Update Posted (Estimate)
May 28, 2008
Last Update Submitted That Met QC Criteria
May 27, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vital-band 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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