Study Stopped
Of those randomised to intervention arm, the majority were not able to tolerate the intervention for the duration of the study indicating that it is not feasible on a larger scale and recruiting 2 extra participants would not change this decision.
Weighted Blankets After Brain Injury
WEBLY
A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2020
CompletedStudy Start
First participant enrolled
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2023
CompletedMarch 4, 2026
March 1, 2026
2.3 years
September 8, 2020
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment
Proportion of eligible candidates recruited within the time frame
12 months
Study Arms (2)
Weighted blankets
EXPERIMENTALProvided with weighted blanket suitable for participant's weight
Standard linen
NO INTERVENTIONUse of standard hospital linen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
April 27, 2021
Study Start
February 11, 2021
Primary Completion
May 16, 2023
Study Completion
May 16, 2023
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share