Using dolls to help reduce agitation in elderly patients with dementia

Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.

Not applicable Interventional Centre Hospitalier Universitaire Vaudois · NCT05691569

This study is testing if giving dolls to elderly patients with dementia can help calm them down and improve their overall well-being.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment92 (estimated)
Ages65 Years and up
SexAll
SponsorCentre Hospitalier Universitaire Vaudois Academic / other
Locations1 site (Lausanne, Canton of Vaud)
Trial IDNCT05691569 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of doll therapy in alleviating behavioral and psychological symptoms of dementia (BPSD) among acute geriatric inpatients. The approach aims to reduce agitation and aggressiveness in patients diagnosed with moderate to severe dementia by providing empathy dolls for interaction. By integrating doll therapy into clinical practice, the study seeks to minimize the reliance on psychotropic medications, shorten hospital stays, and enhance the quality of life for both patients and their caregivers.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly individuals aged 65 and older with moderate to severe dementia who exhibit agitation or aggressiveness.

Not a fit: Patients with mild forms of dementia or those who have contraindications related to doll therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for dementia patients and reduce the burden on caregivers.

How similar studies have performed: While the use of doll therapy is a novel approach in this context, similar interventions have shown promise in improving the well-being of dementia patients in other settings.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* age ≥65 years
* diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2
* presence of agitation and/or aggressiveness
* manual and visual abilities sufficient in order to interact with the doll.

Exclusion Criteria:

* age \<65 years;
* refuse to participate;
* mild forms of dementia (CDR\<2);
* contraindication for DT as experience of mournful or traumatic events related to parental experience;
* life expectancy lower than 3 months;
* infectious diseases requiring isolation;
* negative interaction with the doll,
* presence of delirium.

Where this trial is running

Lausanne, Canton of Vaud

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Dementia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.