Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Public ClinicalTrials.gov record NCT07920497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Project HARMONIA: weigHted blAnkets foR Managing agitatiOn iN crItical cAre
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07920497
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2026 (Actual)
- Primary completion
- Aug 1, 2027 (Estimated)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Nov 5, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AnMed Health | Anderson | South Carolina | 29621 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07920497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2026 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07920497 live on ClinicalTrials.gov.