NCT01020032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

2.2 years

First QC Date

November 23, 2009

Last Update Submit

November 24, 2009

Conditions

Chronic Pain

Keywords

Music therapyPainAnxietyDepressionControlled randomized trial

Outcome Measures

Primary Outcomes (1)

  • Score on a Visual Analogical Scale (VAS) for actual pain

    Day 0, day 5, day 10, day 60 and day 90

Secondary Outcomes (2)

  • Score on the Hospital Anxiety and Depression (HAD) Scale

    Day 0, day 5, day 10, day 60 and day 90

  • Medicinal consumption

    Before hospitalization, day 0, day 5, day 10, day 60 and day 90

Study Arms (1)

Music therapy

EXPERIMENTAL

Individual receptive music therapy by "U sequence" method

Other: Individual receptive music therapy by "U sequence" method

Interventions

Individual receptive music therapy by "U sequence" methodOTHER

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.

Music therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur

Montpellier, 34295, France

Location

Related Publications (3)

  • 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.

    PMID: 17532141BACKGROUND

  • 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.

    PMID: 16625614BACKGROUND

  • 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.

    PMID: 19628939BACKGROUND

Related Links

MeSH Terms

Conditions

Chronic PainPainAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Stéphane GUETIN, PhD

    Association de Musicothérapie Applications et Recherches Cliniques

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

September 1, 2006

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

FR(1)