Back to resultsWeighted Blankets After Brain Injury (WEBLY)
Primary Purpose
Acquired Brain Injury
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Weighted blankets
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury
Eligibility 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
Sites / Locations
- University Hospitals of Derby & Burton NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weighted blankets
Standard linen
Arm Description
Provided with weighted blanket suitable for participant's weight
Use of standard hospital linen
Outcomes
Primary Outcome Measures
Recruitment
Proportion of eligible candidates recruited within the time frame
Secondary Outcome Measures
Full Information
NCT ID
NCT04860973
First Posted
September 8, 2020
Last Updated
August 18, 2023
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04860973
Brief Title
Weighted Blankets After Brain Injury
Acronym
WEBLY
Official Title
A Feasibility Study of Weighted Blankets to Help Agitation and Disturbed Sleep After Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weighted blankets
Arm Type
Experimental
Arm Description
Provided with weighted blanket suitable for participant's weight
Arm Title
Standard linen
Arm Type
No Intervention
Arm Description
Use of standard hospital linen
Intervention Type
Device
Intervention Name(s)
Weighted blankets
Intervention Description
Weighted blankets given to patient for 7 days/nights
Primary Outcome Measure Information:
Title
Recruitment
Description
Proportion of eligible candidates recruited within the time frame
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospitals of Derby & Burton NHS Foundation Trust
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weighted Blankets After Brain Injury
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