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

NCT ID: NCT06161480

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2024-12-12

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Weighted Blanket

To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.

Group Type: OTHER

Weighted Blanket

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VCU Health Systems

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20027241

Identifier Type: -

Identifier Source: org_study_id