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临床试验/NCT01009606
NCT01009606已完成4 期

Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
570
试验地点
2
主要终点
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30

研究概览

简要总结

The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

详细描述

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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 victim of a cardiac arrest and resuscitation initiated
  • Occurrence of cardiac arrest at home
  • Presence of a relative :
  • husband or spouse
  • father or mother
  • son or daughter
  • brother or sister
  • Patient's age ≥ 18 years
  • Relative's age ≥ 18 years
  • Consent of the relative to the participation in the study

排除标准

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security

结局指标

主要结局

Percentage of relatives having a score of the Impact of Events Scale (IES) > 30

时间窗: 3 months

次要结局

  • Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)(3 and 12 months)
  • Psychological follow-up(3 months)
  • Suicide(3 and 12 months)
  • Medico-legal recourse(12 months)
  • Quality of the cardiopulmonary resuscitation(day 0)
  • Questionnaire evaluating the stress of the medical and paramedical team(day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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