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

February 5, 2026 updated by: Virginia Commonwealth University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Participants Experience Survey
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of Total ICU Length of Stay (Days)
Time Frame: From participant enrollment until participant is downgraded from ICU level of care
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)
Time Frame: From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first)
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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)
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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)
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings