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

NCT ID: NCT00772226

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Ponv Fatigue

Keywords

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laparoscopic cholecystectomy pain PONV music therapy fatigue after elective laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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music

Group Type ACTIVE_COMPARATOR

music pillow

Intervention Type DEVICE

according to randomisation patients will receive with/without music.

Pillow without music

Group Type PLACEBO_COMPARATOR

pillow without music

Intervention Type DEVICE

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

Interventions

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music pillow

according to randomisation patients will receive with/without music.

Intervention Type DEVICE

pillow without music

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Randers Regional Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thorbjorn Sommer

Consultant M.D, Ph.D ass Proff

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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DaySurgical unit Regionshospital Randers

Randers, , Denmark

Site Status

Regions Hospital Randers

Randers, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20080031

Identifier Type: -

Identifier Source: org_study_id