N/A
N=49
Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT06161480 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Study Participants Experience Survey — 3.61 Scores on a likert scale (1-5)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weighted Blanket (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Participants Experience Survey |
3.61 | — |
| PRIMARY LAR Experience Survey |
— | — |
| PRIMARY Nurse and Provider Experience Survey |
3.73; 2.69 | — |
| SECONDARY Analysis of Total ICU Length of Stay (Days) |
4.16 | — |
| SECONDARY Analysis of Total ICU Length of Stay on Study (Days) |
1.94 | — |
| SECONDARY Analysis of Total Number of Ventilator Days During Current ICU Admission |
0.82 | — |
| SECONDARY Analysis of Total Number of Ventilator Days on Study |
0.39 | — |
| SECONDARY Richmond Agitation Sedation Scale (RASS) |
-0.62 | — |
| SECONDARY Hours of Blanket Usage Per Day (24 Hours) |
2 | — |
| SECONDARY Confusion Assessment Method for the ICU (CAM-ICU) |
0.22 | — |
Summary
The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.
Eligibility Criteria
Patient Inclusion Criteria:
- 18 years of age or older.
- Requiring ICU level of care.
- Have a primary medical diagnosis.
- Proficient in English.
Patient Exclusion Criteria:
- 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.
Data sourced from ClinicalTrials.gov (NCT06161480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.