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The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted Blanket | Other | To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Total ICU Length of Stay (Days) | 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) |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCU Health Systems | Richmond | Virginia | 23298 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only 18 participants completed the study participant experience survey. Completion was voluntary. | Posted | Mean | Standard Deviation | Scores on a likert scale (1-5) | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
|
From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly Orr, PhD | Virginia Commonwealth University | 804-221-5159 | michelle.orr@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2025 | Dec 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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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 | 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 | 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) | 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) | 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) | 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 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | 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. | Posted | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on Likert scale (1-5) | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
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|
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| Secondary | Analysis of Total ICU Length of Stay (Days) | Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days). | Posted | Mean | Standard Deviation | Days | From participant enrollment until participant is downgraded from ICU level of care |
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| Secondary | 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) | Posted | Mean | Standard Deviation | Days | From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | 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 |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Days | 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 |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a 10-point scale | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Hours per day | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |