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Clinical Trials/NCT00772226
NCT00772226
Completed
Phase 3

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

Randers Regional Hospital2 sites in 1 country204 target enrollmentSeptember 2008
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ConditionsPainPonvFatigue

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pain
Sponsor
Randers Regional Hospital
Enrollment
204
Locations
2
Primary Endpoint
Significant reduction in post operative VAS score
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Randers Regional Hospital
Responsible Party
Principal Investigator
Principal Investigator

Thorbjorn Sommer

Consultant M.D, Ph.D ass Proff

Randers Regional Hospital

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

Outcomes

Primary Outcomes

Significant reduction in post operative VAS score

Time Frame: 1 week

Secondary Outcomes

  • Significant reduction in Stress hormone level (Cortisol and C reactive protein)(1 day)

Study Sites (2)

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