Weighted Blanket for Ventilated Patients

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
Must be taking: Sedation, Analgesia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a specially designed weighted blanket can help ICU patients feel more comfortable and less stressed while being weaned off a breathing machine. The blanket is tailored for ICU needs, with adjustable weight and shape options. Researchers aim to determine if it helps keep patients calm and at ease during this process. Patients on a ventilator, about to start weaning off it, and able to consent through themselves or a representative, might be suitable for this study. Participants will use either the weighted blanket or standard hospital bedding. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions in the ICU.

What prior data suggests that this weighted blanket is safe for ICU patients?

Research has shown that weighted blankets are generally safe and well-tolerated. One study found they can be safely used on the chest of infants and children without causing breathing problems. Another study showed that ICU patients using weighted blankets experienced fewer cases of confusion and coma, indicating safety in critical care settings. Weighted blankets also reduce anxiety and stress without affecting vital body functions like heart rate or breathing. These findings suggest that weighted blankets can be a safe option for enhancing comfort and relaxation during medical care.12345

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for ventilated patients because they offer a non-invasive way to potentially improve patient comfort and reduce anxiety. Unlike medications that are traditionally used to manage anxiety and stress, such as sedatives or anti-anxiety drugs, weighted blankets work by providing gentle, distributed pressure that can have a calming effect, similar to a hug. This approach is different because it doesn't involve pharmaceuticals, reducing the risk of medication-related side effects and complications. Plus, weighted blankets are easy to implement alongside usual care, making them a practical addition to the hospital setting.

What evidence suggests that this weighted blanket is effective for ventilator weaning?

This trial will compare the use of a weighted blanket with standard hospital linens for ventilated patients. Studies have shown that weighted blankets can reduce anxiety and stress without affecting vital signs such as heart rate or blood pressure. In one study, patients felt significantly less anxious after using a weighted blanket for just 30 minutes. Another study found that over 85% of participants felt calmer after using one. Reports also indicate that these blankets can improve sleep and promote relaxation in various situations. Overall, early research suggests that weighted blankets might offer comfort and relaxation in stressful environments like the ICU.12456

Who Is on the Research Team?

JE

Jennifer E. Cahill, PhD, RN

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for ICU patients who are being taken off a breathing machine (ventilator weaning). Participants must be able to use either standard linens or a weighted blanket as part of their care.

Inclusion Criteria

Patient or legally authorized representative (LAR)/healthcare proxy (HCP) able to provide informed consent
I am 18 years old or older.
My doctor has decided to start taking me off the ventilator.
See 2 more

Exclusion Criteria

I am able to stay lying on my stomach for long periods.
Body mass index ≥35 kg/m² as a precautionary exclusion due to uncertainty regarding pressure distribution and respiratory mechanics during early feasibility testing
My Braden Scale score is 9 or lower and my skin is severely damaged.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a hospital-grade weighted blanket or standard hospital linens during ventilator weaning

Up to 2 weeks
Continuous monitoring in ICU

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 compares the effects of an adjustable, ICU-friendly weighted blanket versus regular hospital linens on comfort and sedation during ventilator weaning. Patients are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Weighted blanketExperimental Treatment1 Intervention
Group II: Standard hospital linensPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Weighted Blanket to Improve Sedation and Comfort During ...

blankets have been used to improve patient comfort; Helps patients stay in a light, comfortable level of sedation during ventilator weaning Is ...

The Effect of Limiting Anterior Chest Wall Movement With a ...

The objectives of this exploratory study were to describe the safety, comfort, and effects of applying a weighted blanket to restrict ...

Weighted Blanket to Improve Sedation and Comfort During ...

Previous studies suggest that weighted blankets may reduce anxiety and physiologic stress without negatively affecting vital signs.

Weighted Blanket to Improve Sedation and... | Clinical Trial

Weighted blankets have been used to improve patient comfort; however, the design of standard weighted blankets can interfere with the ICU ...

Weighted Blankets to Improve Sleep in Intensive Care Unit ...

Based on the scores, weighted blankets resulted in a larger reduction in anxiety after 30 minutes compared to no blanket.

Blanket Bolus

Decreased the average ventilator days 9.4% Increased patients' comments of feeling safe and feeling comfort Increased nurses' comments of patients' increased ...