Clinical trial NCT01020032: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Music therapy
Pain
Anxiety
Depression
Controlled randomized trial
Lead sponsor: Association de Musicothérapie Applications et Recherches Cliniques
Sponsor class: OTHER
Collaborators: name: Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi
name: Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve
name: Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier
First posted: 2009-11-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Score on a Visual Analogical Scale (VAS) for actual pain
timeFrame: Day 0, day 5, day 10, day 60 and day 90
Secondary outcomes:
measure: Score on the Hospital Anxiety and Depression (HAD) Scale
timeFrame: Day 0, day 5, day 10, day 60 and day 90
measure: Medicinal consumption
timeFrame: Before hospitalization, day 0, day 5, day 10, day 60 and day 90
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur
Study officials:
affiliation: Association de Musicothérapie Applications et Recherches Cliniques
name: Stéphane GUETIN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.