Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2027-08-30

Brief Summary

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Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events.

The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia.

The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.

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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled open label trial with two parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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doll therapy

The doll used in the study is the "empathy doll"; these dolls are designed to obtain an optimal interaction with patients and to arouse empathy

Group Type EXPERIMENTAL

doll therapy

Intervention Type OTHER

empathy dolls

non anthropomorphic object

non- anthropomorphic soft object

Group Type OTHER

doll therapy

Intervention Type OTHER

empathy dolls

Interventions

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doll therapy

empathy dolls

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No