Effect of Music Therapy on Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Individual receptive music therapy by "U sequence" method
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Music therapy, Pain, Anxiety, Depression, Controlled randomized trial
Eligibility Criteria
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
Sites / Locations
- CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music therapy
Arm Description
Individual receptive music therapy by "U sequence" method
Outcomes
Primary Outcome Measures
Score on a Visual Analogical Scale (VAS) for actual pain
Secondary Outcome Measures
Score on the Hospital Anxiety and Depression (HAD) Scale
Medicinal consumption
Full Information
NCT ID
NCT01020032
First Posted
November 23, 2009
Last Updated
November 24, 2009
Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Collaborators
Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi, Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve, Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01020032
Brief Title
Effect of Music Therapy on Pain
Official Title
Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Collaborators
Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi, Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve, Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Music therapy, Pain, Anxiety, Depression, Controlled randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Individual receptive music therapy by "U sequence" method
Intervention Type
Other
Intervention Name(s)
Individual receptive music therapy by "U sequence" method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score on a Visual Analogical Scale (VAS) for actual pain
Time Frame
Day 0, day 5, day 10, day 60 and day 90
Secondary Outcome Measure Information:
Title
Score on the Hospital Anxiety and Depression (HAD) Scale
Time Frame
Day 0, day 5, day 10, day 60 and day 90
Title
Medicinal consumption
Time Frame
Before hospitalization, day 0, day 5, day 10, day 60 and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane GUETIN, PhD
Organizational Affiliation
Association de Musicothérapie Applications et Recherches Cliniques
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17532141
Citation
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.
Results Reference
background
PubMed Identifier
16625614
Citation
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.
Results Reference
background
PubMed Identifier
19628939
Citation
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.
Results Reference
background
Links:
URL
http://www.amarc.fr
Description
AMARC association is specialized in applications and clinical researches in music therapy
Learn more about this trial
Effect of Music Therapy on Pain
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