What side effects are associated with this type of intervention?

Non-pharmacological treatments for delirium, such as multicomponent interventions and physical therapy, generally have minimal side effects compared to pharmacological treatments. These interventions aim to reduce the incidence and duration of delirium through methods like exercise, light therapy, and environmental modifications. Side effects are rare but may include temporary discomfort or mild agitation as patients adjust to new routines or therapies. Weighted blankets, which provide deep pressure stimulation, are being studied for their potential to reduce anxiety and improve sleep, and they are generally well-tolerated with few reported adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved pharmacological treatments for delirium mentioned in the provided context. The use of weighted blankets, which provide deep pressure stimulation to reduce anxiety and improve sleep, is a non-pharmacological approach and is not directly comparable to any FDA-approved drugs for delirium. Current research suggests the need for further trials to explore non-pharmacological interventions for delirium prevention and management.

What other types of research exist?

Promising alternatives to weighted blankets for delirium patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms and improving mood; 2) Vagus Nerve Stimulation (VNS), which has demonstrated benefits in treatment-resistant depression and mood regulation; 3) Guided Imagery and Progressive Muscle Relaxation, which have been effective in reducing pain and anxiety in cancer patients; and 4) Cranial Electrotherapy Stimulation (CES), which has shown safety and efficacy in treating depression and anxiety.

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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 below

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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:

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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).

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

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 more

Awards & 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

0 / 8Eligibility criteria met

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.