Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,289
- 主要终点
- Symptoms related to posttraumatic stress disorder (PTSD)
研究概览
简要总结
This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients.
Participating ICUs had restrictive visiting policies (i.e., <6 hours/day) before randomization.
After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)
详细描述
Family members of ICU patients are particularly exposed to anxiety, depressive, acute stress disorder, and posttraumatic stress disorder symptoms (PTSD).
It is currently unknown what type of interventions/ strategies to cope with postintensive care syndrome family would produce the best improvement. Experts suggest that symptoms in family members are potentially amenable to intervention by ICU staff. One intervention to reduce PTSD could be a liberalization of the visiting hours. However, restrictions on visiting hours in the intensive care unit (ICU) are usually adopted worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Visiting policies: open 24h/24
Visiting policies: 24 hours a day, 7 days a week
干预措施: Visiting policies: 24 hours a day, 7 days a week (Other)
Restriction of visiting policies
Restriction of visiting policies < 6 hours
干预措施: Restriction of visiting policies < 6 hours (Other)
结局指标
主要结局
Symptoms related to posttraumatic stress disorder (PTSD)
时间窗: at day-90 from patient's ICU discharge
Impact event scale (IES). The Impact of Event scale (IES), which assesses symptoms related to post-traumatic stress disorder (PTSD); scores range from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).
次要结局
- Beliefs and attitudes of healthcare workers toward visiting hours(120 days)
- the proportion of family members with High risk of PTSD occurrence(At day-90 from patients'ICU discharge)
- Patients' symptoms of anxiety and depression(At day-90 from patients'ICU discharge)
- the proportion of patients with High risk of PTSD occurrence(At day-90 from patients'ICU discharge)
- Family member's needs(At inclusion)
- Family members' symptoms of anxiety and depression(At inclusion and Day-90 from patient's ICU discharge)