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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

Tracking Information
First Submitted Date  ICMJE September 3, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music Against Psychological Pain in Suicide
Official Title  ICMJE A Controlled, Randomized Study Evaluating the Effecacy of Receptive Music Therapy on Psychological Pain in Suicidal Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Condition  ICMJE
  • Suicide, Attempted
  • Suicidal Ideation
Intervention  ICMJE Other: music therapy
4 music therapy sessions during a period of time of 48 hours. Each session lasts 30 minutes.
Study Arms  ICMJE
  • Experimental: Groupe intervention
    Usual care and music therapy
    Intervention: Other: music therapy
  • No Intervention: Groupe contrôle
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2019)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emilie TECHER +2 62 262 90 62 89 emilie.techer@chu-reunion.fr
Listed Location Countries  ICMJE Réunion
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04085848
Other Study ID Numbers  ICMJE 2017/CHU/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de la Réunion
Study Sponsor  ICMJE Centre Hospitalier Universitaire de la Réunion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erick GOKALSING EPSMR
PRS Account Centre Hospitalier Universitaire de la Réunion
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP