An interventional study of Weighted-blanket and Attention Control: Standard Blanket and Usual Comfort Measures in Psychomotor Agitation and Critical Illness, sponsored by Anmed Health. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Anmed Health · Not applicable, Interventional, and Treatment
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.
Project HARMONIA is a single-center, mixed-methods study conducted in medical/surgical, neuroscience, and cardiac intensive care units at AnMed Health. A three-patient feasibility pilot, with one patient from each participating ICU, will precede a randomized, attention-controlled clinical phase involving 200 adults.
Eligible patients are adults aged 18 years or older with a Richmond Agitation-Sedation Scale (RASS) score of +1 to +3 who meet protocol eligibility requirements. Participants in the randomized phase will be assigned in a 1:1 ratio to the weighted blanket intervention or attention control, using block randomization stratified by ICU. Patients and bedside nurses will not be blinded to treatment assignment.
The intervention group will receive a weighted blanket selected according to the protocol's patient-weight categories. Sessions may last 15 minutes to 2 hours and occur up to twice in 24 hours. The attention-control group will receive a standard blanket, usual comfort measures, and comparable nursing attention and assessment timing. All clinically indicated treatments will continue in both groups.
RASS, heart rate, blood pressure, and respiratory rate will be assessed at baseline, 30 minutes, 1 hour, and 2 hours when sessions continue to those time points. The primary outcome is the change in RASS from baseline to 1 hour. Additional outcomes include as-needed sedative and anxiolytic medication administration, physiologic changes, intervention tolerance, adverse events, ICU length of stay, and ventilator days.
An embedded implementation evaluation will examine protocol adherence, feasibility, nurse satisfaction, and barriers and facilitators to use. Interviews with nurses, patients or family members, and physician champions will explore experiences and sustainability. Patient and family satisfaction will be evaluated if collected.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 188 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →This is the only study on the registry with Anmed Health as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Weighted-blanket
Other: Attention Control: Standard Blanket and Usual Comfort Measures
Participants will receive a protocol-selected, wipe-clean weighted blanket applied by a trained nurse for 15 minutes to 2 hours, as tolerated, up to twice daily, alongside usual ICU care. Physiologic monitoring will continue throughout use. RASS and vital signs will be assessed at baseline, 30 minutes, 1 hour, and 2 hours when the session continues. PRN medication use, tolerance, and safety events will be recorded. The blanket will be removed immediately upon participant request, intolerance, safety concerns, or care-team direction.
Participants will receive a standard, nonweighted blanket for warmth or comfort, regular repositioning, and usual comfort measures. Nursing attention and assessment timing will be comparable to those provided to the weighted blanket group. Agitation, measured using the Richmond Agitation-Sedation Scale (RASS), and heart rate, blood pressure, and respiratory rate will be assessed at baseline, 30 minutes, 1 hour, and 2 hours when the session continues to those time points. PRN sedative and anxiolytic medication use and safety events will be documented on the same schedule as the intervention group. Participants will not receive a weighted blanket during attention-control sessions. All clinically indicated care will continue without delay or restriction.
Change in Richmond Agitation-Sedation Scale (RASS) Score
Change in Richmond Agitation-Sedation Scale (RASS) score from immediately before the study session to 1 hour after initiation of the weighted blanket or attention-control session. Change is calculated as the 1-hour score minus the baseline score and compared between groups. RASS scores range from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm. Positive scores indicate increasing agitation, while negative scores indicate increasing sedation. A negative change indicates a shift toward less agitation or greater sedation and does not necessarily indicate clinical improvement.
Time frame: Baseline and 1 hour
Number of PRN Anxiolytic or Sedative Administrations
Number of as-needed (PRN) anxiolytic or sedative medication administrations recorded in the medication administration record during the 2 hours following the start of each weighted blanket or attention-control session. Medication name, dose, route, and administration time will be recorded.
Time frame: Baseline and 2 hours
Change in Heart Rate
Change in heart rate, measured in beats per minute, from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups.
Time frame: Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points.
Change in Systolic Blood Pressure
Change in systolic blood pressure, measured in millimeters of mercury (mmHg), from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups.
Time frame: Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points.
Change in Diastolic Blood Pressure
Change in diastolic blood pressure, measured in millimeters of mercury (mmHg), from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups.
Time frame: Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points.
ICU Length of Stay
Number of days from ICU admission until ICU discharge.
Time frame: From ICU admission through ICU discharge, up to 30 days.
Duration of Mechanical Ventilation
Total number of days the participant receives invasive mechanical ventilation during the ICU stay.
Time frame: From initiation of invasive mechanical ventilation until discontinuation of invasive mechanical ventilation, up to 30 days.
Plan to share: No — Individual participant data will not be shared with researchers outside the study team. To protect participant confidentiality, access to participant-level clinical data will remain restricted to authorized study personnel. Study findings will be disseminated in aggregate form through publications and presentations.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.
Of 36 non-industry interventional studies with no phase under Psychomotor Agitation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 42. This study's planned 10 months is below that.
Counting every sponsor, half of 36 studies reached it within 17 months; a quarter within 6 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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