Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets

Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study

The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Weighted Blanket

Detailed Description

The Intervention Group

1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
2. Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
3. A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
4. For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
5. At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.

Control Group:

1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
2. The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
• Documented diagnosis of dementia or suspected major neurocognitive disorder.
• Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
• Have a LAR able to sign the consent on behalf of the patient.

Exclusion Criteria:

• Severe pain likely to be exacerbated by use of weighted blanket
• Inability to remove blanket;
• Skin burns or open wounds;
• Admitted on 72 hour hold.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weighted Blanket Cohort; Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).	Other: Weighted Blanket; Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
No Intervention: Control Cohort; Subjects will receive treatment as usual while inpatient, no blanket.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change	Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.	At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change	Assessment of symptoms in palliative patients using numeric analog scales ranging from 0 to 10 to assess levels of pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and well-being. The sum of the scores for all symptoms is defined as the symptom distress score. The range of the sum is 0-100, with a lower score indicating a better outcome. The ESAS-r is a validated tool and publicly available for use.	At baseline and within 72 hours of the last use of the weighted blanket.
Clinical Global Impressions (CGI)	Aggression/Agitation as a measure of the global clinical outcome using a numeric scale ranging from 1-7, with a lower score indicating a better outcome.	At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Maria Lapid, MD, Mayo Clinic

Publications and helpful links

General 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Estimated): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dementia; Agitation; Inpatient
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Dementia; Psychomotor Agitation
• Other Study ID Numbers: 17-009951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No