A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 3
- 主要终点
- Patient self-reported anxiety
研究概览
简要总结
The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.
详细描述
The trial is designed as a prospective multicenter randomized controlled trial including an intervention and a control group. The control group receives an unspecific conversation. The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU. Anxiety will be measured with a VAS during ICU stay and with a questionnaire after ICU discharge.
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
- 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
- 否
入选标准
- •Elective open heart or abdominal surgery including scheduled ICU stay
- •Heart or abdominal surgery or internal patients with non-scheduled ICU stay
- •Informed consent
排除标准
- •Reduced sensual perception
- •Cognitive impairment
- •Not able to answer a questionnaire (e.g. illiterate)
- •Lying in the same room with another patient already included
研究组 & 干预措施
1
Structured information
干预措施: Structured information (Behavioral)
2
Unspecific conversation
干预措施: Unspecific conversation (Other)
结局指标
主要结局
Patient self-reported anxiety
时间窗: First three days on ICU and/or within 24 hours after ICU discharge
次要结局
- Confusion Assessment Method for the ICU (CAM-ICU)(Within first three days on ICU)
- Patient self reported health-related quality of life(3 months after discharge from hospital)