Acquired Brain Injury
Conditions
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.
Interventions
DEVICEWeighted blankets
Weighted blankets given to patient for 7 days/nights
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 12 months | Proportion of eligible candidates recruited within the time frame |
Countries
United Kingdom
Outcome results
None listed