Status:
COMPLETED
Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.
Detailed Description
To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient popula...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Requiring ICU level of care.
- Have a primary medical diagnosis.
- Proficient in English.
Exclusion
- BMI less than 18.5.
- Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
- Known pregnancy.
- Prisoners.
- Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
- Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
- Paralysis effecting an area the weighted blanket will cover.
- Current neuromuscular blocking agent.
- Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
- History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
- Fever of 37.5°C (99.5°F).
- Limited English proficiency.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06161480
Start Date
October 6 2023
End Date
December 12 2024
Last Update
July 28 2025
Active Locations (1)
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1
VCU Health Systems
Richmond, Virginia, United States, 23298