Clinical trial Recruiting at 1 site Interventional Ages 65 and up

Using dolls to help reduce agitation in elderly patients with dementia

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

Run by Centre Hospitalier Universitaire Vaudois · NCT05691569 · Data updated 2026-11-12

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

Study typeInterventional
Ages65 Years and up
SexAll
Enrollment92 (estimated)
SponsorCentre Hospitalier Universitaire Vaudois
Academic / other
Locations1 site (Lausanne, Canton of Vaud)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedMarch 30, 2027
Study endsAugust 30, 2027
Registry record updatedApril 9, 2025
Trial IDNCT05691569 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • geriatric and Geriatric Rehabilitation Unit
    Lausanne, Canton of Vaud, Switzerland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.