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Weighted Blankets to Decrease Agitation in Dementia

Recruiting

This clinical trial will evaluate whether weighted blankets can reduce agitation and aggressive behaviors in hospitalized patients with dementia.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years N/A All No
April 11, 2018
June 30, 2021
30

  • Admission to a hospital's inpatient geriatric psychiatry unit
  • Diagnosis of dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
  • Presence of agitation/aggression symptoms as defined by an aggression score of 4 or greater on at least one item of the Cohen-Mansfield Agitation Inventory Short Version (CMAI)

  • Inability to remove blanket
  • Severe pain exacerbated by use of weighted blanket
  • Skin burns or open wounds
  • Allergy to blanket material
  • Admitted to hospital on a 72-hour hold

Hospitalized individuals with dementia will be provided weighted blankets, equivalent to 10 percent of their body weight at admission, for use while sleeping at night. Nursing staff will complete assessments that measure behavioral disturbances. A control group will not be provided the weighted blankets but will undergo nursing assessments. The study period for each individual is 3 days of hospitalization.

Name City State Zip Status Primary Contact
Mayo Clinic in Rochester
Rochester Minnesota 55905 Recruiting

Mayo Clinic

Name Role Affiliation
Janette C. Leal, MD Principal Investigator Mayo Clinic

Name Phone Email
Monica Walton 507-422-0689 walton.monica@mayo.edu

NCT03643991

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