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Completed

NCT Number: NCT06161480

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VCU Health Systems

Richmond, Virginia, 23298, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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