CompletedNCT06161480Updated Feb 24, 2026Results posted

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

An interventional study of Weighted Blanket in Delirium, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 49
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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 studied

Delirium

Browse trials for

Delirium 1,057

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 49 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 49 participants (actual)

Study arms

Other
Weighted Blanket
To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.
Device: Weighted Blanket

Interventions

DeviceWeighted 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 researchers measure

Primary outcomes

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

Secondary outcomes

Analysis of Total ICU Length of Stay (Days)
Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).
Time frame: 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)
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

Results

Posted Feb 24, 2026

Participant flow

Participant flow — Overall Study
Milestone	Weighted Blanket
Started	49
Completed	30
Not completed	19
Withdrew: Withdrawal by subject	19

Outcome measures

PrimaryStudy 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.

Time frame:: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Reported as:: Mean · Scores on a likert scale (1-5)

Study Participants Experience Survey
Scores on a likert scale (1-5)	Weighted Blanket
Study Participants Experience Survey	3.61 ± 1.29

PrimaryLAR 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.

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

No measurements were reported for this outcome.

PrimaryNurse 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.

Time frame:: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Reported as:: Mean · Score on Likert scale (1-5)

Nurse and Provider Experience Survey
Score on Likert scale (1-5)	Provider Surveys	Nurse Surveys
Nurse and Provider Experience Survey	3.73 ± 1.42	2.69 ± 1.44

SecondaryAnalysis of Total ICU Length of Stay (Days)

Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).

Time frame:: From participant enrollment until participant is downgraded from ICU level of care
Reported as:: Mean · Days

Analysis of Total ICU Length of Stay (Days)
Days	Weighted Blanket
Analysis of Total ICU Length of Stay (Days)	4.16 ± 3.68

SecondaryAnalysis 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)

Time frame:: From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first)
Reported as:: Mean · Days

Analysis of Total ICU Length of Stay on Study (Days)
Days	Weighted Blanket
Analysis of Total ICU Length of Stay on Study (Days)	1.94 ± 1.38

SecondaryAnalysis 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.

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
Reported as:: Mean · Days

Analysis of Total Number of Ventilator Days During Current ICU Admission
Days	Weighted Blanket
Analysis of Total Number of Ventilator Days During Current ICU Admission	0.82 ± 2.56

SecondaryAnalysis 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.

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
Reported as:: Mean · Days

Analysis of Total Number of Ventilator Days on Study
Days	Weighted Blanket
Analysis of Total Number of Ventilator Days on Study	0.39 ± 1.43

SecondaryRichmond 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.

Time frame:: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Reported as:: Mean · Score on a 10-point scale

Richmond Agitation Sedation Scale (RASS)
Score on a 10-point scale	Weighted Blanket
Richmond Agitation Sedation Scale (RASS)	-0.62 ± 1.16

SecondaryHours 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.

Time frame:: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Reported as:: Mean · Hours per day

Hours of Blanket Usage Per Day (24 Hours)
Hours per day	Weighted Blanket
Hours of Blanket Usage Per Day (24 Hours)	2 ± 3.4

SecondaryConfusion 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.

Time frame:: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
Reported as:: Mean · score on a scale

Confusion Assessment Method for the ICU (CAM-ICU)
score on a scale	Weighted Blanket
Confusion Assessment Method for the ICU (CAM-ICU)	0.22 ± 0.42

Adverse events

Collected over From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Weighted Blanket	0/49 (0%)	0/49 (0%)	0/49 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Weighted Blanket
<=18 years	0
Between 18 and 65 years	28
>=65 years	21

Sex: Female, Male
Sex: Female, Male(Participants)	Weighted Blanket
Female	26
Male	23

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Weighted Blanket
Hispanic or Latino	1
Not Hispanic or Latino	46
Unknown or Not Reported	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Weighted Blanket
American Indian or Alaska Native	1
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	27
White	19
More than one race	0
Unknown or Not Reported	2

Region of Enrollment
Region of Enrollment(participants)	Weighted Blanket
United States	49

Study locations

1 site

VCU Health Systems
Richmond, Virginia 23298, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 17, 2025

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06161480
Lead sponsor: Virginia Commonwealth University
Responsible party: Sponsor
First posted: Dec 8, 2023
Start date: Oct 6, 2023
Primary completion: Dec 12, 2024
Completion: Dec 12, 2024
Results posted: Feb 24, 2026
Last update: Feb 24, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Delirium→

Other studies from this sponsor

Virginia Commonwealth University

Start the discussion