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

Phase 3

Completed

• Conditions: Pain; Ponv; Fatigue
• Interventions: Device: music pillow; Device: pillow without music

• Registration Number: NCT00772226
• Lead Sponsor: Randers Regional Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-09
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
music	music pillow	-
Pillow without music	pillow without music	-

Primary Outcome Measures

Name	Time	Method
Significant reduction in post operative VAS score	1 week

Secondary Outcome Measures

Name	Time	Method
Significant reduction in Stress hormone level (Cortisol and C reactive protein)	1 day

Trial Locations

Locations (2)

DaySurgical unit Regionshospital Randers; 🇩🇰 Randers, Denmark

Regions Hospital Randers; 🇩🇰 Randers, Denmark