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Effect of Music Therapy on Pain

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ClinicalTrials.gov Identifier: NCT01020032
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
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
Information provided by:
Association de Musicothérapie Applications et Recherches Cliniques

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Individual receptive music therapy by "U sequence" method Not Applicable

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  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center
Study Start Date : September 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Music therapy
Individual receptive music therapy by "U sequence" method
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.



Primary Outcome Measures :
  1. 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 Measures :
  1. Score on the Hospital Anxiety and Depression (HAD) Scale [ Time Frame: Day 0, day 5, day 10, day 60 and day 90 ]
  2. Medicinal consumption [ Time Frame: Before hospitalization, day 0, day 5, day 10, day 60 and day 90 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020032


Locations
France
CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
Montpellier, France, 34295
Sponsors and Collaborators
Association de Musicothérapie Applications et Recherches Cliniques
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
Investigators
Principal Investigator: Stéphane GUETIN, PhD Association de Musicothérapie Applications et Recherches Cliniques