Weighted Blankets for Delirium

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Commonwealth University

Must not be taking: Neuromuscular blockers

Disqualifiers: Cognitive deficit, Pregnancy, Claustrophobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on a neuromuscular blocking agent, you cannot participate in the trial.

What data supports the effectiveness of the treatment Weighted Blanket for delirium?

There is no direct evidence from the provided research articles about the effectiveness of weighted blankets for delirium. However, non-pharmacological interventions, such as improving sleep and comfort, are mentioned as helpful in managing delirium, which could suggest potential benefits of weighted blankets in creating a calming environment. ^{1 2 3 4 5}

How does the treatment of weighted blankets differ from other treatments for delirium?

Weighted blankets are a unique treatment for delirium as they provide a non-drug, sensory-based approach that may help reduce anxiety and improve sleep, which are factors associated with delirium. Unlike traditional treatments that often involve medications like antipsychotics or benzodiazepines, weighted blankets focus on creating a calming environment to potentially alleviate symptoms without the side effects of drugs. ^{2 4 6 7 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Proficient in English

I have been diagnosed with a primary medical condition.

I am 18 years old or older.

Exclusion Criteria

Limited English proficiency

Paralysis affecting an area the weighted blanket will cover

I am currently taking medication for muscle control.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use weighted blankets to prevent and/or mitigate delirium in adult ICU patients

6 months

Daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Weighted Blanket (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Weighted Blanket Experimental Treatment 1 Intervention

To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VCU Health Systems Richmond, VA

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Patients Recruited

22,900,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-pharmacological and pharmacological therapy of delirium]. Reith, S.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium and its treatment. Attard, A., Ranjith, G., Taylor, D.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Delirium on the ICU: clinical impact, diagnostic workup, and therapy]. Theuerkauf, N., Guenther, U.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experts consensus on the management of delirium in critically ill patients]. Tang, B., Wang, XT., Chen, WJ., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonergic agents in the prevention of delirium: A network meta-analysis of randomized controlled trials. Yang, CP., Tseng, PT., Pei-Chen Chang, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium and Agitation. House, RM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching the environment to patients with delirium: lessons learned from the delirium room, a restraint-free environment for older hospitalized adults with delirium. Flaherty, JH., Little, MO.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium in the elderly. Johnson, JC.[2005]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Non-pharmacological and pharmacological therapy of delirium]. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Delirium and its treatment. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Delirium on the ICU: clinical impact, diagnostic workup, and therapy]. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Experts consensus on the management of delirium in critically ill patients]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Melatonergic agents in the prevention of delirium: A network meta-analysis of randomized controlled trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Delirium and Agitation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Matching the environment to patients with delirium: lessons learned from the delirium room, a restraint-free environment for older hospitalized adults with delirium. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Delirium in the elderly. [2005]