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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01020032
Other study ID # AMARC 200801
Secondary ID
Status Completed
Phase N/A
First received November 23, 2009
Last updated November 24, 2009
Start date September 2006
Est. completion date December 2008

Study information

Verified date November 2009
Source Association de Musicothérapie Applications et Recherches Cliniques
Contact n/a
Is FDA regulated No
Health authority France : Comité de Protection des Personnes
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date December 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur Montpellier

Sponsors (4)

Lead Sponsor Collaborator
Association de Musicothérapie Applications et Recherches Cliniques Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi, Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier, Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve

Country where clinical trial is conducted

France, 

References & Publications (3)

Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004843. — View Citation

Guétin S, Portet F, Picot MC, Pommié 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. — View Citation

Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. Epub 2007 May 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Score on a Visual Analogical Scale (VAS) for actual pain Day 0, day 5, day 10, day 60 and day 90 No
Secondary Score on the Hospital Anxiety and Depression (HAD) Scale Day 0, day 5, day 10, day 60 and day 90 No
Secondary Medicinal consumption Before hospitalization, day 0, day 5, day 10, day 60 and day 90 No
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