Back to resultsThe Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
Primary Purpose
Pain, Ponv, Fatigue
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
music pillow
pillow without music
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring laparoscopic cholecystectomy, pain, PONV, music, therapy, fatigue after elective laparoscopic cholecystectomy
Eligibility Criteria
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
Sites / Locations
- DaySurgical unit Regionshospital Randers
- Regions Hospital Randers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
music
Pillow without music
Arm Description
Outcomes
Primary Outcome Measures
Significant reduction in post operative VAS score
Secondary Outcome Measures
Significant reduction in Stress hormone level (Cortisol and C reactive protein)
Full Information
NCT ID
NCT00772226
First Posted
October 14, 2008
Last Updated
September 9, 2012
Sponsor
Randers Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00772226
Brief Title
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
Official Title
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Randers Regional Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Ponv, Fatigue
Keywords
laparoscopic cholecystectomy, pain, PONV, music, therapy, fatigue after elective laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music
Arm Type
Active Comparator
Arm Title
Pillow without music
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
music pillow
Intervention Description
according to randomisation patients will receive with/without music.
Intervention Type
Device
Intervention Name(s)
pillow without music
Intervention Description
According to randomisation patients will receive a pillow with/without music
Primary Outcome Measure Information:
Title
Significant reduction in post operative VAS score
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Significant reduction in Stress hormone level (Cortisol and C reactive protein)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
DaySurgical unit Regionshospital Randers
City
Randers
ZIP/Postal Code
8900
Country
Denmark
Facility Name
Regions Hospital Randers
City
Randers
ZIP/Postal Code
8900
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
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