Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
研究概览
简要总结
This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.
详细描述
In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent (60000/year in France) and often fatal disease (5% survival). Because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. However little studies have evaluated it. Patients who later develop PTSD, generally have acute stress disorder. In patients with resuscitated sudden cardiac death, acute psychological distress is frequent and PTSD was identified in 40% of patients. Concerning relatives, Haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. PTSD was more frequent in people who were witness of the SCD vs those who were not there. Hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others.
This study will evaluate acute stress disorder with SASRQ scale in patients with resuscitated SCD and their relative just after the event. At 3 months, presence of PTSD will be evaluated with PCL-5 and LEC-5 in patients and their relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients with resuscitated sudden cardiac death and/or their relative
- •Patients who are fluent in French
- •Patients who have given their 'no objection to participation to the research'
- •Patients of both gender over 18 years
- •Women with childbearing potential and effective contraception
排除标准
- •People who are not able to give their 'no objection to participate to the research'
- •People with major cognitive disorders post sudden cardiac death
- •People with known psychiatric disorder
- •Women who are known to be pregnant or lactating
- •Person deprived of liberty by judicial or administrative decision
- •People under legal protection (under the protection of a conservator)
研究组 & 干预措施
Patient and relatives
干预措施: SASRQ questionnaire (Behavioral)
Patient and relatives
干预措施: PCL-5 with LEC-5 questionnaire (Behavioral)
结局指标
主要结局
Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD
时间窗: Month 3
The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire
次要结局
- Proportion of patients and/or relatives with acute stress disorder(Day 0)
- Proportion of patients and/or relatives with trauma vulnerability(Month3)