Weighted Blankets After Brain Injury (WEBLY)

University Hospitals of Derby and Burton NHS Foundation Trust

Status

Terminated

Conditions

Acquired Brain Injury

Treatments

Device: Weighted blankets

Study type

Interventional

Funder types

Other

Identifiers

NCT04860973

UHDB/2020/024

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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