Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Music therapy
  • Individual receptive music therapy by "U sequence" method

Primary Measures

• Score on a Visual Analogical Scale (VAS) for actual pain
  • Time Frame: Day 0, day 5, day 10, day 60 and day 90
    Safety Issue?: No

Secondary Measures

• Score on the Hospital Anxiety and Depression (HAD) Scale
  • Time Frame: Day 0, day 5, day 10, day 60 and day 90
    Safety Issue?: No
• Medicinal consumption
  • Time Frame: Before hospitalization, day 0, day 5, day 10, day 60 and day 90
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Association de Musicothérapie Applications et Recherches Cliniques

Overall Clinical Trial Officials and Contacts

Stéphane GUETIN, PhD Principal Investigator Association de Musicothérapie Applications et Recherches Cliniques  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01020032

Study ID Number: AMARC 200801

ClinicalTrials.gov Identifier: NCT01020032

Health Authority: France : Comité de Protection des Personnes

AMARC association is specialized in applications and clinical researches in music therapy