Trial Outcomes & Findings for Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium (NCT NCT06161480)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

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

Results posted on

2026-02-24

Participant Flow

Healthcare providers completing questionnaires did so voluntarily and anonymously. They were not consented for the study (waiver of consent through IRB) and no details were collected about the providers.

Participant milestones

Participant milestones
Measure	Weighted Blanket To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.
Overall Study STARTED	49
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Weighted Blanket To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.
Overall Study Withdrawal by Subject	19

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.
Age, Categorical <=18 years	0 Participants n=58 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=58 Participants
Age, Categorical >=65 years	21 Participants n=58 Participants
Sex: Female, Male Female	26 Participants n=58 Participants
Sex: Female, Male Male	23 Participants n=58 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=58 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	27 Participants n=58 Participants
Race (NIH/OMB) White	19 Participants n=58 Participants
Race (NIH/OMB) More than one race	0 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=58 Participants
Region of Enrollment United States	49 participants n=58 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=18 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Study Participants Experience Survey	3.61 Scores on a likert scale (1-5) Standard Deviation 1.29	—

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=11 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys n=13 Participants Surveys administered to nurses
Nurse and Provider Experience Survey	3.73 Score on Likert scale (1-5) Standard Deviation 1.42	2.69 Score on Likert scale (1-5) Standard Deviation 1.44

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Analysis of Total ICU Length of Stay (Days)	4.16 Days Standard Deviation 3.68	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Analysis of Total ICU Length of Stay on Study (Days)	1.94 Days Standard Deviation 1.38	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Analysis of Total Number of Ventilator Days During Current ICU Admission	0.82 Days Standard Deviation 2.56	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Analysis of Total Number of Ventilator Days on Study	0.39 Days Standard Deviation 1.43	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Richmond Agitation Sedation Scale (RASS)	-0.62 Score on a 10-point scale Standard Deviation 1.16	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Hours of Blanket Usage Per Day (24 Hours)	2 Hours per day Standard Deviation 3.4	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Weighted Blanket n=49 Participants To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. 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.	Nurse Surveys Surveys administered to nurses
Confusion Assessment Method for the ICU (CAM-ICU)	0.22 score on a scale Standard Deviation 0.42	—

Adverse Events

Weighted Blanket

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shelly Orr, PhD

Virginia Commonwealth University

Phone: 804-221-5159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place