NCT06161480

Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).

Conditions

• Delirium

Interventions

Type	Name	Description
DEVICE	Weighted Blanket	Weighted Blanket is an occupational therapy modality which has been associated with significant increases in grounding, orientation to reality, soothing, and quality of life.

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-12-12
• Completion: 2024-12-12
• First posted: 2023-12-08
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study