Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275483
• Other study ID #: Vital-band 01
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: May 27, 2008
• Start date: May 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2008
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2007
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acupressure Point P6
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• Vital-band (R)

Locations

Country	Name	City	State
Denmark	Herlev University Hospital, department of anaestesiology	Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting
Secondary	1: The use of conventionel antiemetic treatment.
Secondary	2: Lenght of stay in the perioperative unit.
Secondary	3: overall lenght of stay