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CompletedNCT00772226Updated Sep 11, 2012

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

A Phase 3 interventional study of music pillow and pillow without music in Pain, Ponv and Fatigue, sponsored by Randers Regional Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-11.

Sponsored by Randers Regional Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Ponv
  • Fatigue

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Keywords

  • laparoscopic cholecystectomy
  • pain
  • PONV
  • music
  • therapy
  • fatigue after elective laparoscopic cholecystectomy
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 204 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Randers Regional Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients going for laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • Age below 18,
  • Use of NSAID, morphine, steroids
  • Disability
  • Previous surgery in the past month
  • Pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
204 participants (actual)

Study arms

  • Active comparator
    music

    Device: music pillow

  • Placebo comparator
    Pillow without music

    Device: pillow without music

Interventions

  • Devicemusic pillow

    according to randomisation patients will receive with/without music.

  • Devicepillow without music

    According to randomisation patients will receive a pillow with/without music

06

What researchers measure

Primary outcomes

  1. Significant reduction in post operative VAS score

    Time frame: 1 week

Secondary outcomes

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

    Time frame: 1 day

07

Study locations

2 sites
  • DaySurgical unit Regionshospital Randers
    Randers, 8900, Denmark
  • Regions Hospital Randers
    Randers, 8900, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00772226
Lead sponsor
Randers Regional Hospital
Responsible party
Thorbjorn Sommer (Consultant M.D, Ph.D ass Proff, Randers Regional Hospital) — Principal investigator
First posted
Oct 15, 2008
Start date
Sep 2008
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Sep 11, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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