Back to resultsMusic Against Psychological Pain in Suicide (MAPPS)
Primary Purpose
Suicide, Attempted, Suicidal Ideation
Status
Suspended
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
music therapy
Sponsored by
About this trial
This is an interventional other trial for Suicide, Attempted
Eligibility Criteria
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
Sites / Locations
- Etablissement Public de Santé Mentale de La Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Groupe intervention
Groupe contrôle
Arm Description
Usual care and music therapy
Usual care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04085848
First Posted
September 3, 2019
Last Updated
October 19, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT04085848
Brief Title
Music Against Psychological Pain in Suicide
Acronym
MAPPS
Official Title
A Controlled, Randomized Study Evaluating the Effecacy of Receptive Music Therapy on Psychological Pain in Suicidal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
COVID pandemy
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Groupe intervention
Arm Type
Experimental
Arm Description
Usual care and music therapy
Arm Title
Groupe contrôle
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
music therapy
Intervention Description
4 music therapy sessions during a period of time of 48 hours. Each session lasts 30 minutes.
Primary Outcome Measure Information:
Title
Change from inclusion psychological pain at 48 hours after inclusion
Description
Pain analogical visual scale (scale ranges : from 0 to 10) min = 0 = no psychological pain and max = 10 = maximum psychological pain
Time Frame
48 hours after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erick GOKALSING
Organizational Affiliation
EPSMR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etablissement Public de Santé Mentale de La Réunion
City
Saint-Paul
ZIP/Postal Code
97460
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Music Against Psychological Pain in Suicide
We'll reach out to this number within 24 hrs