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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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.

Quick Facts

Study Start:2023-10-06

Study Completion:2024-12-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06161480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 years of age or older. * Requiring ICU level of care. * Have a primary medical diagnosis. * Proficient in English.	* 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.

Inclusion Criteria

Exclusion Criteria

* 18 years of age or older.
* Requiring ICU level of care.
* Have a primary medical diagnosis.
* Proficient in English.

* 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.

Contacts and Locations

Study Locations (Sites)

VCU Health Systems

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06

Study Completion Date2024-12-12

Study Record Updates

Study Start Date2023-10-06

Study Completion Date2024-12-12

Terms related to this study

Additional Relevant MeSH Terms

Delirium