Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients (AGITATE)

Vaud University Hospital Center

Status: Enrolling

Conditions: Dementia

Treatments: Other: doll therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05691569

agitate

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

doll therapy

Experimental group

Description:

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

Treatment:

Other: doll therapy

non anthropomorphic object

Other group

Description:

non- anthropomorphic soft object

Treatment:

Other: doll therapy