Skip to main content
OpenTrials
Completed

NCT Number: NCT03643991

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

The Intervention Group

  • Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
  • Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
  • A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
  • 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.
  • 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:

  • Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weighted Blanket

Other

Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.

Primary outcomes

  1. Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change

    Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

    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.

Secondary outcomes

  1. The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change

    Time frame: At baseline and within 72 hours of the last use of the weighted blanket.

    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.

  2. Clinical Global Impressions (CGI)

    Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2018
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.