Efficacy of the Use of Diaries in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.
详细描述
Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •admitted intensive care unit
- •sedated and mechanically ventilated for 24hours
- •signed consent
- •not language barrier
- •willingness to attend follow-up visits
排除标准
- •verbal manifestation of psychiatric, mental or cognitive antecedents
- •who do not coluntarily agree to participate
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: 12 months
questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin.
SF-36 Health Survey
时间窗: 12 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Revised Impact of Event Scales (IES-R)
时间窗: 12 months
questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.
次要结局
未报告次要终点
研究者
Pilar Muñoz Rey
principal investigator
University of Barcelona