跳至主要内容
临床试验/NCT04085848
NCT04085848招募中不适用

A Controlled, Randomized Study Evaluating the Effecacy of Receptive Music Therapy on Psychological Pain in Suicidal Patients

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 2 个国家目标入组 264 人开始时间: 2020年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
264
试验地点
2
主要终点
Change from inclusion psychological pain at 48 hours after inclusion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Groupe intervention

Experimental

Usual care and music therapy

干预措施: music therapy (Other)

Groupe contrôle

No Intervention

Usual care

结局指标

主要结局

Change from inclusion psychological pain at 48 hours after inclusion

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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