A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
详细描述
A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.
12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. Sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded.
Participants (where possible) and staff members will be interviewed about their experience and opinions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving assent on the subject's behalf
- •Aged over 18 years
- •Admitted to King's Lodge Neurorehabilitation Unit for inpatient rehabilitation after a brain injury
- •Within weight limits to be suitable for weighted blanket use
排除标准
- •On end of life pathway
- •Pain which could be exacerbated by weighted blanket
- •Unable to remove
- •Presence of open wound / pressure sore
- •Allergy to blanket material
- •Participant or consultee unable or unwilling to give informed consent / assent
- •Known respiratory disorder such as asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea which could be exacerbated by use of heavy blanket over chest
- •Claustrophobia
研究组 & 干预措施
Weighted blankets
Provided with weighted blanket suitable for participant's weight
干预措施: Weighted blankets (Device)
Standard linen
Use of standard hospital linen
结局指标
主要结局
Recruitment
时间窗: 12 months
Proportion of eligible candidates recruited within the time frame
次要结局
未报告次要终点