NCT04085848

Brief Summary

This study compares the efficacy of music therapy associated with standard care versus the standard care alone on the psychological pain in suicidal patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

6.2 years

First QC Date

September 3, 2019

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from inclusion psychological pain at 48 hours after inclusion

    Pain analogical visual scale (scale ranges : from 0 to 10) min = 0 = no psychological pain and max = 10 = maximum psychological pain

    48 hours after inclusion

Study Arms (2)

Groupe intervention

EXPERIMENTAL

Usual care and music therapy

Other: music therapy

Groupe contrôle

NO INTERVENTION

Usual care

Interventions

4 music therapy sessions during a period of time of 48 hours. Each session lasts 30 minutes.

Groupe intervention

Eligibility Criteria

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

You may qualify if:

  • Patient with suicidal ideas, thoughts or surviving suicide attempt
  • Patient whose emergency somatic management lasted less than 48h
  • Patient who, according to the physician, is still in suicidal mood
  • Patient admitted in the psychiatric hospitalization unit of the Public Mental Health Establishment
  • Patient with voluntary admission and agrees to stay in hospital from 48h to 60h
  • Patient able to write and read in french
  • Patient affiliated to a social security scheme
  • Patient who gives his Informed consent before any procedure related to the study

You may not qualify if:

  • Patient with attempt suicide requiring a somatic care (intensive, surgery, gastric lavage...)
  • Patient with medical history of audiogenic and/or musicogenic epilepsy
  • Patient with major impairment of hearing function
  • Patient unable to support the headhset earphone
  • Patient with contra indication to BZD, hypnotics (Zopiclone) or requiring more sedative and/or psychotic drugs
  • Patient under guardianship or under judicial protection
  • Patient hospitalized at the request of a third party or ex officio

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement Public de Santé Mentale de La Réunion

Saint-Paul, 97460, Reunion

RECRUITING

MeSH Terms

Conditions

Suicide, AttemptedSuicidal Ideation

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Erick GOKALSING

    EPSMR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 11, 2019

Study Start

February 25, 2020

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations