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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772226
First Posted: October 15, 2008
Last Update Posted: September 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thorbjorn Sommer, Randers Region Hospital
  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
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Further study details as provided by Thorbjorn Sommer, Randers Region Hospital:

Primary Outcome Measures:
  • Significant reduction in post operative VAS score [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Significant reduction in Stress hormone level (Cortisol and C reactive protein) [ Time Frame: 1 day ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772226


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

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
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Thorbjorn Sommer, Randers Region Hospital:
laparoscopic cholecystectomy
pain
PONV
music
therapy
fatigue after elective laparoscopic cholecystectomy

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms