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

NCT06161480 | Completed Results DMC FDA Device

• 1 other identifier: HM20027241
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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)

  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

  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

  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)

  From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

Study Arms (1)

Weighted Blanket

OTHER

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

Device: Weighted Blanket

Interventions

Weighted Blanket 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.

Weighted Blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

VCU Health Systems

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Shelly Orr, PhD
• Organization: Virginia Commonwealth University

michelle.orr@vcuhealth.org

804-221-5159

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study that will be conducted in a convenience sample of adult medicine ICU patients. Healthcare providers caring for enrolled patients will also be asked to complete questionnaires related to experience providing care to patients enrolled in the study. Patient participants will be enrolled in the study. Healthcare providers will not be considered enrolled as questionnaires are voluntary and anonymous and these healthcare providers will not be consented (waiver of consent through IRB) for participation.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 8, 2023
• Study Start: October 6, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (1)