Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Not Applicable

Recruiting

• Conditions: Dementia
• Interventions: Other: doll therapy

• Registration Number: NCT05691569
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-20
• Study Start: 2024-11-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2027-03-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doll therapy	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
non anthropomorphic object	doll therapy	non- anthropomorphic soft object

Primary Outcome Measures

Name	Time	Method
behavioural and psychological symptoms of dementia	baseline, discharge (up to one week)	Neuro Psychiatic Inventory (NPI). The NPI total score ranges from 0 to 144, higher scores means more severe and frequent behavioural and psycological symptoms of dementia
agitation and aggressiveness within hospital	baseline and hospital discharge discharge (up to one week)	measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation
agitation and aggressiveness outside hospital	baseline, 1 and 4 weeks after discharge	Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation

Secondary Outcome Measures

Name	Time	Method
patients' quality of life	baseline and 4 weeks after discharge	by the use of the AD-5D Dementia Utility Instrument, the scales scores between -1 to 1, the highest score indicate the better quality of life
family caregivers' quality of life	baseline and 4 weeks after discharge	by the EuroQoL 5-Dimensions 5 level versions. the scale scores from 5 to 25 the highest the score the lowest the quality of life
family caregiver burden	baseline and 4 weeks after discharge	Caregiver Burden Inventory (CBI) scale. The Caregiver Burden Inventory comprises 24 closed questions divided into five dimensions: time-dependence, developmental, physical, social and emotional burden. There are five items in each dimension except for physical burden, which has four items dedicated to. Each item is given a score between 0 (not at all descriptive) and 4 (very descriptive), where higher scores indicate greater caregiver burden; there are no cut-off points for classifying burden. Therefore, total scores for factors one, two, four and five can range from zero to 20. An equivalent score for physical burden can be obtained by multiplying the sum of items in this dimension by 1.25
professional caregiver burden	baseline and at hospital discharge (up to one week)	Staff Stress Measure Dementia Care (SSMDC). The scale comprised the following 27 items producing a five-factor solution: Frustrated empathy; difficulties understanding and interpreting; balancing competing needs; balancing emotional involvement; and lack of recognition.
incidence of delirium	every day during hospital stay (up to one week)	measured by the Confusion Assessment Method (CAM) scale. For a diagnosis of delirium by CAM, the patient must display: 1. Presence of acute onset and fluctuating discourse AND; 2. Inattention AND EITHER; 3. Disorganized thinking OR; 4. Altered level of consciousness

Trial Locations

Locations (1)

geriatric and Geriatric Rehabilitation Unit; 🇨🇭 Lausanne, Vaud, Switzerland