Weighted blankets tested to calm ICU delirium
NCT ID NCT06161480
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether weighted blankets can help prevent or reduce delirium in adult ICU patients. 49 participants used the blankets, and researchers measured satisfaction from patients, their families, and healthcare providers. The goal was to see if this simple, non-drug approach is feasible and helpful in both city and rural hospitals.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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VCU Health Systems
Richmond, Virginia, 23298, United States
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Other studies related to the condition(s) this trial covers.
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