Psychomotor AgitationHARMONIANCT07920497
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
A study testing Weighted-blanket in people with Psychomotor Agitation and Critical Illness, run by Anmed Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychomotor Agitation, Critical Illness
- What is being tested?
- Weighted-blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Admission to participating unit.
- Baseline RAAS score +1 to +3.
- Able to provide informed consent or have a legally authorized representative provide consent.
- Clinically appropriate for blanket use as determined by the care team.
Who cannot join
- Pregnancy.
- Open wounds or burns involving more than 20% body surface area or otherwise preventing safe application.
- Claustrophobia or documented anxiety related to confined spaces.
- Low muscle tone when clinically relevant to safe blanket use.
- Inability to regulate temperature.
- Orthopedic injury that makes blanket pressure inappropriate.
- Limb restraints in use.
- Anticipated ICU discharge within 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project HARMONIA: weigHted blAnkets foR Managing agitatiOn iN crItical cAre
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.
Read the detailed description
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.
- Conditions
- Psychomotor Agitation, Critical Illness
- Being tested
- Weighted-blanket, Attention Control: Standard Blanket and Usual Comfort Measures
- Keywords
- agitation, critical illness, nonpharmacologic intervention, deep pressure stimulation, richmond agitation-sedation scale, patient comfort
- Medical subject headings
- Psychomotor Agitation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted-blanketOther
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.
Attention Control: Standard Blanket and Usual Comfort MeasuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Weighted Blanket | Experimental | Not described Receives: Other: Weighted-blanket |
| Attention Control | Other | Not described Receives: Other: Attention Control: Standard Blanket and Usual Comfort Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 hour
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From initiation of invasive mechanical ventilation until discontinuation of invasive mechanical ventilation, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Oct 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anmed Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Critical Care Nurses
- Responsible party
- Principal investigator, Andrea Franks, Anmed Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920497
- Sponsor's protocol ID
- 25-010
- Other IDs
- 40302
- Acronym
- HARMONIA
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.
PubMed 40009836Dimas A, Lober A, Reeves R. Pilot Study of Weighted Blankets on Agitation. J Neurosci Nurs. 2025 Feb 1;57(1):37-40. doi: 10.1097/JNN.0000000000000799. Epub 2024 Nov 21.
PubMed 39621814Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
PubMed 24334188Lonn M, Odeus E. Outcome Measures in Evaluation of Weighted Blankets: A Scoping Review. Occup Ther Int. 2025 Feb 19;2025:3663534. doi: 10.1155/oti/3663534. eCollection 2025.
PubMed 40018070Lewis K, Balas MC, Stollings JL, McNett M, Girard TD, Chanques G, Kho ME, Pandharipande PP, Weinhouse GL, Brummel NE, Chlan LL, Cordoza M, Duby JJ, Gelinas C, Hall-Melnychuk EL, Krupp A, Louzon PR, Tate JA, Young B, Jennings R, Hines A, Ross C, Carayannopoulos KL, Aldrich JM. A Focused Update to the Clinical Practice Guidelines for the Prevention and Management of Pain, Anxiety, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2025 Mar 1;53(3):e711-e727. doi: 10.1097/CCM.0000000000006574. Epub 2025 Feb 21.
PubMed 39982143Eron K, Kohnert L, Watters A, Logan C, Weisner-Rose M, Mehler PS. Weighted Blanket Use: A Systematic Review. Am J Occup Ther. 2020 Mar/Apr;74(2):7402205010p1-7402205010p14. doi: 10.5014/ajot.2020.037358.
PubMed 32204779Burk RS, Grap MJ, Munro CL, Schubert CM, Sessler CN. Agitation onset, frequency, and associated temporal factors in critically ill adults. Am J Crit Care. 2014 Jul;23(4):296-304. doi: 10.4037/ajcc2014186.
PubMed 24986170
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project HARMONIA: weigHted blAnkets foR Managing agitatiOn iN crItical cAre
- ClinicalTrials.gov ID
- NCT07920497
- Acronym / sponsor ID
- HARMONIA / 25-010
- Conditions
- Psychomotor Agitation, Critical Illness
- Keywords
- agitation, critical illness, nonpharmacologic intervention, deep pressure stimulation, richmond agitation-sedation scale, patient comfort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Anmed HealthUniversity, hospital or other
- Collaborators
- American Association of Critical Care Nurses
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket | Experimental | Other: Weighted-blanket |
| Attention Control | Other | Other: Attention Control: Standard Blanket and Usual Comfort Measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Admission to participating unit.
- Baseline RAAS score +1 to +3.
- Able to provide informed consent or have a legally authorized representative provide consent.
- Clinically appropriate for blanket use as determined by the care team.
Key exclusion criteria (8 listed)
- Pregnancy.
- Open wounds or burns involving more than 20% body surface area or otherwise preventing safe application.
- Claustrophobia or documented anxiety related to confined spaces.
- Low muscle tone when clinically relevant to safe blanket use.
- Inability to regulate temperature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted-blanketParticipants 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. | Other | Weighted Blanket |
| Attention Control: Standard Blanket and Usual Comfort MeasuresParticipants 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. | Other | Attention Control |
Primary outcome
Change in Richmond Agitation-Sedation Scale (RASS) Score
Time frame: Baseline and 1 hour
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.
6 secondary outcomes
Number of PRN Anxiolytic or Sedative Administrations
Time frame: Baseline and 2 hours
Change in Heart Rate
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
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
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
Time frame: From ICU admission through ICU discharge, up to 30 days.
Duration of Mechanical Ventilation
Time frame: From initiation of invasive mechanical ventilation until discontinuation of invasive mechanical ventilation, up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 40009836Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.
- Background: PubMed 39621814Dimas A, Lober A, Reeves R. Pilot Study of Weighted Blankets on Agitation. J Neurosci Nurs. 2025 Feb 1;57(1):37-40. doi: 10.1097/JNN.0000000000000799. Epub 2024 Nov 21.
- Background: PubMed 24334188Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
- Background: PubMed 40018070Lonn M, Odeus E. Outcome Measures in Evaluation of Weighted Blankets: A Scoping Review. Occup Ther Int. 2025 Feb 19;2025:3663534. doi: 10.1155/oti/3663534. eCollection 2025.
- Background: PubMed 39982143Lewis K, Balas MC, Stollings JL, McNett M, Girard TD, Chanques G, Kho ME, Pandharipande PP, Weinhouse GL, Brummel NE, Chlan LL, Cordoza M, Duby JJ, Gelinas C, Hall-Melnychuk EL, Krupp A, Louzon PR, Tate JA, Young B, Jennings R, Hines A, Ross C, Carayannopoulos KL, Aldrich JM. A Focused Update to the Clinical Practice Guidelines for the Prevention and Management of Pain, Anxiety, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2025 Mar 1;53(3):e711-e727. doi: 10.1097/CCM.0000000000006574. Epub 2025 Feb 21.
- Background: PubMed 32204779Eron K, Kohnert L, Watters A, Logan C, Weisner-Rose M, Mehler PS. Weighted Blanket Use: A Systematic Review. Am J Occup Ther. 2020 Mar/Apr;74(2):7402205010p1-7402205010p14. doi: 10.5014/ajot.2020.037358.
- Background: PubMed 24986170Burk RS, Grap MJ, Munro CL, Schubert CM, Sessler CN. Agitation onset, frequency, and associated temporal factors in critically ill adults. Am J Crit Care. 2014 Jul;23(4):296-304. doi: 10.4037/ajcc2014186.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted-blanket in people with Psychomotor Agitation and Critical Illness, run by Anmed Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Richmond Agitation-Sedation Scale (RASS) Score (time frame: Baseline and 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07920497, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.