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Music Against Psychological Pain in Suicide (MAPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085848
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Suicidal Ideation Other: music therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: A Controlled, Randomized Study Evaluating the Effecacy of Receptive Music Therapy on Psychological Pain in Suicidal Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Groupe intervention
Usual care and music therapy
Other: music therapy
4 music therapy sessions during a period of time of 48 hours. Each session lasts 30 minutes.

No Intervention: Groupe contrôle
Usual care



Primary Outcome Measures :
  1. Change from inclusion psychological pain at 48 hours after inclusion [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 to a short term hospital psychiatric unit at Saint Paul or Saint Denis
  • Patient with voluntary admission and agrees to stay in hospital for 48h
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085848


Contacts
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Contact: Emilie TECHER +2 62 262 90 62 89 emilie.techer@chu-reunion.fr

Locations
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Réunion
Etablissement Public de Santé Mentale de La Réunion
Saint-Paul, Réunion, 97460
Contact: Erick GOKALSING         
Sub-Investigator: Cécile JANIN, MD         
Sub-Investigator: Mickaël CRAPET, MD         
Sub-Investigator: Aurélie BOINON, MD         
Sub-Investigator: Agnès PASQUIER, MD         
Sub-Investigator: Anne-Valérie PINTO, MD         
Principal Investigator: Erick GOKALSING, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Principal Investigator: Erick GOKALSING EPSMR

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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04085848    
Other Study ID Numbers: 2017/CHU/19
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms