Using weighted blankets to help prevent delirium in ICU patients

The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.

This study is testing if using weighted blankets can help prevent delirium in adult ICU patients and make their stay more comfortable.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Virginia Commonwealth University (Academic / other)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT06161480 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility and acceptability of using weighted blankets as a nonpharmacologic intervention to prevent or reduce delirium in adult patients in the ICU. It aims to gather preliminary data on the effects of weighted blankets on various outcomes such as agitation, ICU length of stay, and medication usage. The study also explores innovative methods for recruiting rural participants and providing remote healthcare provider training and support. By examining these factors, the research seeks to inform future efficacy trials in this critical care population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who require ICU care and have a primary medical diagnosis.

Not a fit: Patients with significant cognitive deficits, certain skin injuries, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a simple, non-invasive method to reduce the incidence and severity of delirium in critically ill patients.

How similar studies have performed: While the use of weighted blankets is a novel approach in this context, similar nonpharmacologic interventions have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 18 years of age or older.
* Requiring ICU level of care.
* Have a primary medical diagnosis.
* Proficient in English.

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.

Where this trial is running

Richmond, Virginia

• VCU Health Systems — Richmond, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Heather Fudala, PhD

Conditions Delirium