Weighted Blankets for Delirium

Overseen By Shelly Orr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Neuromuscular blockers

Disqualifiers: Cognitive deficit, Pregnancy, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether weighted blankets can prevent or reduce delirium (sudden confusion) in adults in the ICU. The goal is to determine if these blankets can help patients feel calmer and more comfortable during their stay. It targets adults who require intensive care, have a primary medical condition, and can speak English. Those with significant cognitive impairment or certain skin injuries may not qualify for participation. As an unphased trial, this study provides a unique opportunity to contribute to understanding how non-drug interventions can enhance patient comfort in critical care settings.

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 prior data suggests that weighted blankets are safe for adult ICU patients?

Research has shown that weighted blankets are generally safe for various groups. One study found that weighted blankets were not only safe for dementia patients but also appreciated by both patients and hospital staff. Another study demonstrated their safety for children in hospitals, with negative effects occurring in only 1.2% of cases.

For older adults in nursing homes, weighted blankets have proven to be safe and beneficial, leading to several health improvements. Researchers are also studying their potential to help manage confusion in ICU patients. Current research suggests they are well-tolerated and pose minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for delirium because they offer a non-pharmacological approach to managing this condition. Unlike standard treatments that often rely on medications like antipsychotics or sedatives, weighted blankets work by providing deep pressure stimulation, which can have a calming effect on the nervous system. This method could potentially reduce the need for drugs, minimizing side effects and offering a more holistic way to help patients, particularly in ICU settings. Plus, weighted blankets are easy to use and can be beneficial for a wide range of patients, including those in both urban and rural areas.

What evidence suggests that weighted blankets are effective for delirium?

Research has shown that weighted blankets in ICU settings might help reduce delirium, a condition causing confusion and disorientation. This trial will assess the effectiveness of weighted blankets in preventing or mitigating delirium. One study found a significant decrease in delirium and coma cases among ICU patients who used weighted blankets. Hospitals consider these blankets safe and practical. Although this research mainly focused on ICU patients, it suggests that weighted blankets could help keep patients calmer and more aware of their surroundings. Overall, early findings are promising for using weighted blankets to manage delirium symptoms. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 need care in the intensive care unit.

Exclusion Criteria

Limited English proficiency

Paralysis affecting an area the weighted blanket will cover

I am currently taking medication for muscle control.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

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.

How Is the Trial Designed?

Group I: Weighted Blanket Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Delirium is a serious condition that affects consciousness and cognitive function, particularly in medically or surgically compromised patients, and is linked to high rates of morbidity and mortality.

Effective treatment focuses on identifying the underlying cause, using antipsychotics like haloperidol for symptom management, and providing supportive care, including family involvement and environmental adjustments to enhance patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium and Agitation. House, RM.[2022]

Delirium is a common and serious condition affecting 20% of hospitalized elderly patients, characterized by fluctuating attention and cognitive deficits, and can lead to high mortality and complications such as falls and dehydration.

Effective management of delirium involves treating the underlying illness, ensuring proper hydration and nutrition, minimizing unnecessary medications, and using haloperidol for severe symptoms, while avoiding anticholinergic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A systematic review of six randomized controlled trials involving 913 older adults showed that melatonergic agents, particularly low doses of melatonin (0.5 mg/day), significantly reduce the risk of developing delirium compared to placebo.

The analysis indicated that melatonin at 5 mg/day and ramelteon at 8 mg/day also effectively prevent delirium, supporting the use of these agents in clinical guidelines for at-risk patients.

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]

The primary treatment for delirium focuses on non-pharmacological interventions, such as early mobilization and cognitive reorientation, which are essential for improving patient outcomes.

While specific medications for delirium are limited, the choice of sedatives can significantly affect the incidence of delirium, highlighting the importance of careful medication management in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Delirium is a serious condition affecting 10-92% of hospitalized patients, leading to long-term cognitive deficits, increased dependence, and higher mortality rates, making its prevention crucial.

Effective management of delirium involves daily structured screening and addressing modifiable risk factors, with potential treatment options including behavioral interventions and possibly medications like anti-inflammatory and antipsychotic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Delirium in critically ill patients is a complex clinical syndrome that can be influenced by factors such as pain, anxiety, and sleep disruption, highlighting the importance of comprehensive management strategies to address these underlying causes.

Early identification and intervention, including daily assessments and environmental improvements, can significantly reduce the incidence and duration of delirium, ultimately improving patient outcomes in intensive care settings.

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]

Delirium affects 10% to 30% of hospital admissions and is associated with longer hospital stays and higher mortality, making prevention the most effective strategy to reduce its occurrence and complications.

Antipsychotics, particularly haloperidol, are the primary pharmacological treatment for delirium symptoms, with haloperidol being favored for its safety profile and effectiveness, while benzodiazepines like lorazepam are recommended for cases not controlled by antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

The Delirium Room (DR) model, which emphasizes nonpharmacological care and a restraint-free environment, has shown potential in reducing negative outcomes associated with delirium in older hospitalized adults, such as loss of function and longer hospital stays.

Observational data suggest that the DR model can achieve outcomes comparable to those seen in individuals without delirium, and it does not appear to increase fall rates compared to traditional care settings, although more rigorous studies are needed to confirm these findings.

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]

Citations

1. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1093&context=ysmpa_theses

Weighted Blankets to Improve Sleep in Intensive Care Unit ... They observed a significant reduction in the incidence of delirium/coma during the ICU stay and a significant increase in daily ICU delirium/ ...

2. withpower.com withpower.com/trial/phase-delirium-9-2023-81e11

Weighted Blankets for Delirium · Info for Participants 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596321003535

Feasibility trial of weighted blankets as an intervention for ... The study demonstrated weighted blanket use is safe and feasible with children in the hospital setting.

4. nursing.gmu.edu nursing.gmu.edu/news/2023-05/nursing-phd-student-receives-grant-sigma-theta-tau-research-preventing-icu-delirium

Nursing PhD student receives grant from Sigma Theta Tau for ... Smith's research seeks to identify if the use of weighted blankets has an effect on the symptoms of ICU delirium for patients who are mechanically ventilated.

5. ctv.veeva.com ctv.veeva.com/study/feasibility-and-acceptability-of-using-weighted-blankets-to-prevent-and-or-mitigate-delirium

Feasibility and Acceptability of Using Weighted Blankets to ... To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904365/

Weighted Blankets for Agitation in Hospitalized Patients ... The aim of this study is to investigate the effect of weighted blankets on aggression and agitation in hospitalized patients with dementia.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jan.17049

Evaluating the Safety, Feasibility and Acceptability of ... This study provides evidence that weighted blankets may be used safely with the acceptance of patients with dementia and staff in hospitals.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9408528/

Weighted Blankets' Effect on the Health of Older People ... Conclusions: A weighted blanket seems to be an effective and safe intervention for older people in nursing homes, as several improvements were ...