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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04085848
Other study ID # 2017/CHU/19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2020
Est. completion date February 2025

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de la Réunion
Contact Emilie TECHER
Phone +2 62 262 90 62 89
Email emilie.techer@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Music therapy consists of using the Music Care tool. Each patient randomized in the music therapy arm should perform 4 music therapy sessions of 30 minutes on 48h. Before and after each music therapy sessions, the psychological pain will be measured by the analogical visual scale. Standard care consists of a medical and paramedical interview lasting 20-30 minutes. At the end of the interview, a drug treatment (BZD anxiolytic and/or hypnotic) is prescribed and the patient is hospitalized. During hospitalization, patient is regularly interviewed in order to evaluate his psychological status.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Réunion Etablissement Public de Santé Mentale de La Réunion Saint-Paul

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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