- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020032
Effect of Music Therapy on Pain
November 24, 2009 updated by: Association de Musicothérapie Applications et Recherches Cliniques
Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center
The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The "U" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature.
The objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology.
During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60.
The evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion).
The evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Montpellier, France, 34295
- CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a pain for more than 6 months
- Pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve)
- Speak and read French fluently
- Wrote consent of patients
- Benefit from the standard treatment : Intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request)
Exclusion Criteria:
- Time of hospitalization < 8 days
- Reflex epilepsy history
- Major insufficiency of auditory function
- Patient with a strong possibility of not compliance to the protocol or of abandon in the course of study
- Presence of an illness threatening vital forecast during period envisaged for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Music therapy
Individual receptive music therapy by "U sequence" method
|
During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Score on a Visual Analogical Scale (VAS) for actual pain
Time Frame: Day 0, day 5, day 10, day 60 and day 90
|
Day 0, day 5, day 10, day 60 and day 90
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Score on the Hospital Anxiety and Depression (HAD) Scale
Time Frame: Day 0, day 5, day 10, day 60 and day 90
|
Day 0, day 5, day 10, day 60 and day 90
|
|
Medicinal consumption
Time Frame: Before hospitalization, day 0, day 5, day 10, day 60 and day 90
|
Before hospitalization, day 0, day 5, day 10, day 60 and day 90
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stéphane GUETIN, PhD, Association de Musicothérapie Applications et Recherches Cliniques
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
- Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
- Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
November 23, 2009
First Submitted That Met QC Criteria
November 24, 2009
First Posted (ESTIMATE)
November 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
November 25, 2009
Last Update Submitted That Met QC Criteria
November 24, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMARC 200801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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