Back to resultsPrevention of Postoperative Nausea and Vomiting (PONV) by Acupressure
Primary Purpose
Postoperative Nausea and Vomiting, Acupressure Point P6
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vital-band (R)
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
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.
Sites / Locations
- Herlev University Hospital, department of anaestesiology
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting
Secondary Outcome Measures
1: The use of conventionel antiemetic treatment.
2: Lenght of stay in the perioperative unit.
3: overall lenght of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00275483
Brief Title
Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Acupressure Point P6
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Vital-band (R)
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Secondary Outcome Measure Information:
Title
1: The use of conventionel antiemetic treatment.
Title
2: Lenght of stay in the perioperative unit.
Title
3: overall lenght of stay
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte Majholm, MD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev University Hospital, department of anaestesiology
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure
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