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Weighted Blankets for Agitation

(HARMONIA Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Anmed Health
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?

The purpose of this study is to learn whether weighted blankets help reduce agitation, such as restlessness or excessive movement, in adults in an intensive care unit (ICU). Researchers will compare a weighted blanket with a standard blanket and usual comfort measures. They will also examine safety and the use of medicines given as needed to manage agitation or anxiety.

After a three-patient pilot to test study procedures, 197 adults will be assigned by chance to one of two groups. One group will receive a weighted blanket, and the other will receive a standard blanket with usual comfort measures. Both groups will receive similar nursing attention and continue all needed medical care. Weighted blanket sessions may last 15 minutes to 2 hours, up to twice daily, with close monitoring.

Researchers will compare agitation before and after each session, with the main comparison at 1 hour. They will also examine vital signs, medicine use, safety events, time in the ICU, and days requiring a breathing machine. Participation may or may not improve comfort or agitation.

Are You a Good Fit for This Trial?

This trial is for adults in the intensive care unit (ICU) who are experiencing agitation, such as restlessness or excessive movement. People with certain medical conditions may not be eligible, but specific exclusions aren't listed here.

Inclusion Criteria

I am 18 years old or older.
Admission to participating unit
Baseline RAAS score +1 to +3
See 2 more

Exclusion Criteria

Claustrophobia or documented anxiety related to confined spaces
Low muscle tone when clinically relevant to safe blanket use
I do not have large open wounds or burns that would prevent safe treatment.
See 5 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares using a weighted blanket versus a standard blanket and usual comfort measures to see if the weighted blanket helps reduce agitation in ICU patients. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Weighted BlanketExperimental Treatment1 Intervention
Group II: Attention ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anmed Health

Lead Sponsor

American Association of Critical Care Nurses

Collaborator

Trials
4
Recruited
180+

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