ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 2
- 主要终点
- Post traumatic stress disorder symptoms in patients
研究概览
简要总结
The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.
详细描述
Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives
Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge
Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.
An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.
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
- Single (Outcomes Assessor)
盲法说明
the psychologist is blind for the study for assessing outcome measures
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
- •Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours
排除标准
- •Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
- •Patients or families not fluent in French
- •Patients moribund
- •Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
- •Patients admitted after a cardiac arrest
- •Deaf and mute patients
研究组 & 干预措施
With diary
a ICU diary is open by staff for the patient and his relatives during the ICU stay
干预措施: ICU diary (Other)
Without diary
No diary is open during the ICU stay
结局指标
主要结局
Post traumatic stress disorder symptoms in patients
时间窗: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
IES-R score \> 22
次要结局
- Anxiety and depression related symptoms in patients(3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale)
- Anxiety and depression related symptoms in families(3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale)
- Post traumatic stress disorder symptoms in families(3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire)
- Recollection of the memories of the ICU stay by the patient(3 months after ICU discharge as measured by the memory tool questionnaire)