跳至主要内容
临床试验/NCT06366191
NCT06366191
尚未招募
不适用

Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

Centre Hospitalier Universitaire de la Réunion0 个研究点目标入组 40 人2025年10月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Psychological Trauma
发起方
Centre Hospitalier Universitaire de la Réunion
入组人数
40
主要终点
study acceptability rate
状态
尚未招募
最后更新
9个月前

概览

简要总结

A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.

注册库
clinicaltrials.gov
开始日期
2025年10月1日
结束日期
2026年7月1日
最后更新
9个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
责任方
Sponsor

入排标准

入选标准

  • Person who the vital prognosis has or could have been committed or having felt a threat to his physical and/or psychological integrity
  • After a potentially traumatic event dating from a minimum of 72 hours to a maximum of 1 week
  • for which the CUMP or the psychotrauma regulation platform has been requested
  • having lived or being a direct witness of the event
  • knowing how to read and write
  • affiliate or beneficiary of a social security scheme
  • having signed a consent
  • Non-inclusion Criteria:
  • guardianship or curatorship
  • unable to receive phone calls

排除标准

  • 未提供

结局指标

主要结局

study acceptability rate

时间窗: 6 months after inclusion

Number of included patient divided by number of patients to whom the study was offered. Study acceptability rate of 50% is expected.

次要结局

  • Adherence of patient to the watch(1 month after inclusion)
  • Patient satisfaction (qualitatif)(3 months after inclusion)
  • Evolution of the patient journey in experimental arm(3 months after inclusion)
  • Adherence of patient to the health watch(3 months after inclusion)
  • Strong points of the health watch(3 months after inclusion)
  • Patient satisfaction (quantitatif)(3 months after inclusion)
  • Occurrence of post-traumatic stress disorder(3 months after inclusion)
  • Complications associated with post-traumatic stress disorder(3 months after inclusion)

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