NCT02524067已完成不适用
Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Agitation on Agitated Behaviour Scale (ABS)
研究概览
简要总结
This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with moderate and severe Traumatic Brain Injury (TBI)
- •Diagnosed with Glasgow Coma Score (GCS) lower than 13-
排除标准
- •Patients with psychiatric diagnose and not speaking danish -
研究组 & 干预措施
Intervention
Experimental
Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient
干预措施: Multifactorial circadian concept (Behavioral)
结局指标
主要结局
Agitation on Agitated Behaviour Scale (ABS)
时间窗: One year
Functional abilities on the Early Functional Abilities Scale (EFA)
时间窗: One year
Functional abilities on the Glasgow Outcome Extend Scale
时间窗: 12 month after admission
次要结局
- Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)(One year)
研究者
研究点 (1)
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