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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thorbjorn Sommer, Randers Region Hospital
ClinicalTrials.gov Identifier:
NCT00772226
First received: October 14, 2008
Last updated: September 9, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pain
Ponv
Fatigue
Device: music pillow
Device: pillow without music
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Resource links provided by NLM:


Further study details as provided by Randers Regional Hospital:

Primary Outcome Measures:
  • Significant reduction in post operative VAS score [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant reduction in Stress hormone level (Cortisol and C reactive protein) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: music Device: music pillow
according to randomisation patients will receive with/without music.
Placebo Comparator: Pillow without music Device: pillow without music
According to randomisation patients will receive a pillow with/without music

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772226

Locations
Denmark
Regions Hospital Randers
Randers, Denmark, 8900
DaySurgical unit Regionshospital Randers
Randers, Denmark, 8900
Sponsors and Collaborators
Randers Regional Hospital
  More Information

No publications provided

Responsible Party: Thorbjorn Sommer, Consultant M.D, Ph.D ass Proff, Randers Region Hospital
ClinicalTrials.gov Identifier: NCT00772226     History of Changes
Other Study ID Numbers: 20080031
Study First Received: October 14, 2008
Last Updated: September 9, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Randers Regional Hospital:
laparoscopic cholecystectomy
pain
PONV
music
therapy
fatigue after elective laparoscopic cholecystectomy

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014