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| Sponsored by: |
Randers Region Hospital |
|---|---|
| Information provided by: | Randers Region Hospital |
| ClinicalTrials.gov Identifier: | NCT00772226 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| music: Active Comparator |
Device: music pillow
according to randomisation patients will receive with/without music.
|
| Pillow without music: Placebo Comparator |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thorbjorn sommer, consultant | +4589102570 | tbs@rc.aaa.dk |
| Contact: lars soemod, consultant | +4590102570 | LAO@rc.aaa.dk |
| Denmark | |
| Regions Hospital Randers | Recruiting |
| Randers, Denmark, 8900 | |
| Contact: Thorbjorn Sommer , consultant +4589102570 tbs@rc.aaa.dk | |
| Principal Investigator: Thorbjorn Sommer, Consultant | |
| Sub-Investigator: Lars Soemod, Consultant | |
| DaySurgical unit Regionshospital Randers | Recruiting |
| Randers, Denmark, 8900 | |
| Contact: sommer tbs@rc.aaa.dk | |
| Contact: soemod lao@rc.aaa.dk | |
More Information
| Responsible Party: | Thorbjorn Sommer ( Department of Surgery ) |
| Study ID Numbers: | 20080031 |
| Study First Received: | October 14, 2008 |
| Last Updated: | October 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00772226 |
| Health Authority: | Denmark: Videnskabsetisk Komité for Region Midtjylland |
|
laparoscopic cholecystectomy pain PONV |
music therapy fatigue after elective laparoscopic cholecystectomy |
|
Signs and Symptoms Fatigue Pain |
