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

50 Participants Needed

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}

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 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

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

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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]