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NCT00772226 Clinical Trial

The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Pain Clinical Trial

Official title:
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00772226
Other study ID # 20080031
Secondary ID
Status Completed
Phase Phase 3
First received October 14, 2008
Last updated September 9, 2012
Start date September 2008
Est. completion date September 2012

Study information
Verified date September 2012
Source Randers Regional 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 study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.

Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients going for laparoscopic cholecystectomy

Exclusion Criteria:

- Age below 18,

- Use of NSAID, morphine, steroids

- Disability

- Previous surgery in the past month

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• music pillow
according to randomisation patients will receive with/without music.
• pillow without music
According to randomisation patients will receive a pillow with/without music

Locations
Country Name City State
Denmark DaySurgical unit Regionshospital Randers Randers
Denmark Regions Hospital Randers Randers

Sponsors (1)
Lead Sponsor Collaborator
Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Significant reduction in post operative VAS score 1 week No
Secondary Significant reduction in Stress hormone level (Cortisol and C reactive protein) 1 day No
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