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.

The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Device: Weighted Blanket

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).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Weighted Blanket; To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participants Experience Survey	Study Participants will be asked to complete a survey describing their experience with using the weighted blanket upon discharge from the ICU or if they stop using the weighted blanket, to determine if participants felt using the weighted blanket was beneficial to their overall health improvement. The full name is "Participant Weighted Blanket Satisfaction Survey." A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were 6 questions total. Total score was averaged.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
LAR Experience Survey	LAR will complete survey describing his/her perspective of the participant's use of the weighted blanket to improve family member's health outcome. LAR will complete survey after participant has been discharged from ICU or participant is no longer using the weighted blanket.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Nurse and Provider Experience Survey	The nurse and healthcare provider will complete surveys once their patient has completed the use of the weighted blanket describing whether they felt the weighted blanket improved the health outcome of their patients. The full name is "Nurse & Provider Weighted Blanket Experience Survey" A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were questions total. Total score was averaged.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Total ICU Length of Stay (Days)	Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).	From participant enrollment until participant is downgraded from ICU level of care
Analysis of Total ICU Length of Stay on Study (Days)	Study Team will collect data daily and conduct analysis of total ICU Length of Stay on Study (Days)	From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first)
Analysis of Total Number of Ventilator Days During Current ICU Admission	Study Team will collect data daily and conduct analysis of total Number of Ventilator Days.	From current ICU admission date until participant is downgraded from ICU level of care, an average of 4 days. This measure includes any vent days prior to the participant being enrolled in the study
Analysis of Total Number of Ventilator Days on Study	Study Team will collect data daily and conduct analysis of total number of Ventilator Days on Study.	From study enrollment date until participant is downgraded from ICU level of care, an average of 4 days. This measure only looks at vent days while enrolled and does NOT include vent days prior to enrollment
Richmond Agitation Sedation Scale (RASS)	Study Team will collect data daily and conduct analysis of the daily chart review data. RASS is a 10-point tool (ranging from +4 combative to -5 unarousable) used in critical care to assess a patient's level of alertness, agitation, or sedation, helping healthcare providers guide therapy and prevent over/under-sedation, with 0 being alert and calm, positive scores indicating agitation, and negative scores indicating sedation, assessed by observation, verbal, and then physical stimuli as needed.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Hours of Blanket Usage Per Day (24 Hours)	Study Team will collect data daily and conduct analysis of the Blanket Usage Log. Number collected reflects hours per day that blanket was utilized by study participant. Range was 0-24. Zero meaning no usage and 24 meaning constant usage for the 24-hour period.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Confusion Assessment Method for the ICU (CAM-ICU)	Study Team will collect data daily and conduct analysis of data from the CAM-ICU, a rating scale used by bedside clinicians to assess delirium for patients in the intensive care unit. The CAM-ICU evaluates the presence delirium. Score range is 0-1 where 0 is no delirium present and 1 is delirium present, with 0 being the more desired outcome.	From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium
• Other Study ID Numbers: HM20027241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No