Weighted Blankets After Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury

Conditions
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Acquired Brain Injury

Intervention / Treatment
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* Device: Weighted blankets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weighted blankets<br>Provided with weighted blanket suitable for participant's weight | Device: Weighted blankets<br>* Weighted blankets given to patient for 7 days/nights<br>|
| No Intervention: Standard linen<br>Use of standard hospital linen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Proportion of eligible candidates recruited within the time frame | 12 months |