Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 625
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10
研究概览
简要总结
Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.
详细描述
Family members are often shocked and devastated by the death of their loved one, especially when it is sudden and unexpected. On the scene, families often don't really believe it happened because they didn't have time to absorb the fact of their loss. They hear the words and explanation given by the prehospital emergency medical services (EMS) team, but do not comprehend the full impact. Emotions seem frozen. They feel disoriented, restless, stunned and unable to think.
Most often, after cardiac arrest resuscitation attempt, the prehospital EMS team leaves the scene, letting the family without any further medical bond and support. Families are left alone facing this tragedy. After a while, families need medical counseling trying to understand what happens and why but they don't know who to consult. Instead, they remain without medical explanation or guidance with the fear regarding their own future, in particular, regarding the risk of dying from sudden death. This fear may be based on the knowledge of the eventuality of familial diseases increasing the risk of sudden death, or simply on a mechanism of identification with the deceased.
One important factor credited by experts is to encourage first-degree family members to seek sudden death counselling. However, the literature concerning this problem lacks of reliable data.
The aim of this clinical trial is to evaluate the psychological consequences of a sudden death counselling on family member after a relative's sudden death compared to the usual family management.
This study will compare the percentage of depression in a group of family members after a relative's sudden death for whom a sudden death counselling has been proposed by the prehospital medical team versus a group for whom the medical team has not modified its usual strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A first-degree relative of a:
- •patient aged 18-75 years
- •with an out-of-hospital sudden death*
- •and cardiopulmonary resuscitation attempted Relative aged ≥ 18 years Given consent for the study. Sudden death definition*: An unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms).
排除标准
- •Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance
结局指标
主要结局
Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10
时间窗: At 3 months from the sudden death
Percentage of relatives with moderate to severe symptoms of anxiety evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Anxiety (HADSA) \>10
Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10
时间窗: at 3 months from the sudden death
Percentage of relatives with moderate to severe symptoms of depression evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Depression (HADSD) \>10
次要结局
- Drug use(At 3 months from the sudden death)
- Medical Outcome Study Short Form Health Survey (SF-12)(At 3 months from the sudden death)
- Visits number to the psychologist and/or psychiatrist(At 3 months from the sudden death)
- Relatives number integrating a grief recovery support group(At 3 months from the sudden death)
- Feeling of the sudden death consultation or not by the relatives(At 3 months from the sudden death)
- Proportion of identified causes of sudden death(At 3 months from the sudden death)
- Proportion of familial screening(At 3 months from the sudden death)
- Impact of Event Scale-revised score (IES-R) ≥ 33(at 3 months from the sudden death)
- Visits number to the general physician(At 3 months from the sudden death)
