DeliriumNCT06161480

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

A study testing Weighted Blanket in people with Delirium, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Delirium
What is being tested?: Weighted Blanket
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 6 Oct 2023to 12 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

VCU Health Systems
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: 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.

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: Delirium
Being tested: Weighted Blanket
Medical subject headings: Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06161480
Study group	Role	What they receive
Weighted Blanket	Other	To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. Receives: Device: Weighted Blanket

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202312 Dec 2024

First posted8 Dec 2023
Study start6 Oct 2023
Primary completion12 Dec 2024
Study completion12 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DeliriumStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06161480
Sponsor's protocol ID: HM20027241
Status last verified: Feb 2026
First submitted: 27 Nov 2023
Last updated: 24 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium

All Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.
ClinicalTrials.gov ID: NCT06161480
Acronym / sponsor ID: HM20027241
Conditions: Delirium
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: 6 Oct 2023 (actual)
Primary completion: 12 Dec 2024 (actual)
Study completion: 12 Dec 2024 (actual)
First posted: 8 Dec 2023 (actual)
Results: Posted 24 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Weighted Blanket	Other	Device: Weighted BlanketTo prevent and or mitigate delirium in adult ICU patients in urban and rural populations.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.
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.
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.

7 secondary outcomes

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

Results and safety

Results posted to the registry on 24 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Weighted Blanket	49	30

Primary outcome: Study Participants Experience Survey

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

Measure	Weighted Blanket n = 18
Value	3.61 (1.29)

Population analysed: Only 18 participants completed the study participant experience survey. Completion was voluntary.

Primary outcome: LAR Experience Survey

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

Population analysed: This outcome measure wasn't analyzed as no data was collected. This data would have been collected when the participant was transferred from the ICU if their LAR was available. At the time of the transfer, no LARs were available and therefore this data couldn't have been collected.

Primary outcome: Nurse and Provider Experience Survey

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

Measure	Provider Surveys n = 11	Nurse Surveys n = 13
Value	3.73 (1.42)	2.69 (1.44)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Weighted Blanket	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Delirium

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Weighted Blanket in people with Delirium, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Participants Experience Survey (time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.