Weighted Blankets After Brain Injury
- Conditions
- Acquired Brain Injury
- Interventions
- Device: Weighted blankets
- Registration Number
- NCT04860973
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weighted blankets Weighted blankets Provided with weighted blanket suitable for participant's weight
- Primary Outcome Measures
Name Time Method Recruitment 12 months Proportion of eligible candidates recruited within the time frame
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals of Derby & Burton NHS Foundation Trust
🇬🇧Derby, United Kingdom