Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2021-02-11
2023-05-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Weighted blankets
Provided with weighted blanket suitable for participant's weight
Weighted blankets
Weighted blankets given to patient for 7 days/nights
Standard linen
Use of standard hospital linen
No interventions assigned to this group
Interventions
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Weighted blankets
Weighted blankets given to patient for 7 days/nights
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Locations
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University Hospitals of Derby & Burton NHS Foundation Trust
Derby, , United Kingdom
Countries
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Other Identifiers
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UHDB/2020/024
Identifier Type: -
Identifier Source: org_study_id
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