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Weighted Blankets for Delirium
N/A
Recruiting
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Requiring ICU level of care
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether weighted blankets can help prevent or reduce delirium in adult ICU patients. Delirium is a condition that causes confusion and agitation. The blankets work by providing a comforting weight that helps calm the body, similar to a hug.
Who is the study for?
This trial is for adults over 18 who need ICU care and can speak English. It's not for those with a BMI under 18.5, severe cognitive issues from permanent injury or disease, pregnant women, prisoners, skin injuries where the blanket goes, paralysis in that area, muscle relaxant use, recent fractures under the blanket area, claustrophobia history or fever above 37.5°C.
What is being tested?
The study tests if weighted blankets can help prevent or ease delirium in adult ICU patients. Participants will use these blankets to see if they feel more settled and less confused during their ICU stay.
What are the potential side effects?
Weighted blankets are generally safe but could cause discomfort like overheating or feeling trapped for some people; especially important to monitor in an ICU setting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I need care in the intensive care unit.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for muscle control.
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I have recent fractures in areas that a blanket would cover.
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I have a permanent cognitive impairment due to a severe condition or injury.
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I currently do not have a fever over 37.5°C (99.5°F).
Select...
I have a history of claustrophobia.
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I have a skin injury where a blanket's weight could worsen it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
LAR Experience Survey
Nurse and Provider Experience Survey
Study Participants Experience Survey
Secondary study objectives
Analysis of total ICU Length of Stay (Days)
Analysis of total ICU Length of Stay on Study (Days)
Analysis of total Number of Ventilator Days (This admission)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Weighted BlanketExperimental Treatment1 Intervention
To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weighted Blanket
2017
N/A
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-pharmacological treatments for delirium, such as the use of weighted blankets, work primarily through mechanisms of deep pressure stimulation (DPS). DPS can help reduce anxiety and promote relaxation by stimulating the release of neurotransmitters like serotonin and dopamine, which are associated with mood regulation.
Additionally, these interventions can improve sleep quality by providing a calming effect that helps maintain circadian rhythms. This is particularly important for delirium patients, as anxiety and poor sleep are significant contributing factors to the onset and exacerbation of delirium.
By addressing these issues, non-pharmacological treatments can help mitigate the severity and duration of delirium episodes.
Outcomes and measures of delirium interventional studies in palliative care to inform a core outcome set: A systematic review.The effectiveness of non-pharmacological interventions in reducing the incidence and duration of delirium in critically ill patients: a systematic review and meta-analysis.Interventions for preventing delirium in hospitalised non-ICU patients.
Outcomes and measures of delirium interventional studies in palliative care to inform a core outcome set: A systematic review.The effectiveness of non-pharmacological interventions in reducing the incidence and duration of delirium in critically ill patients: a systematic review and meta-analysis.Interventions for preventing delirium in hospitalised non-ICU patients.
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
718 Previous Clinical Trials
22,895,746 Total Patients Enrolled