Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

NCT05691569 | Recruiting

• 1 other identifier: agitate
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (3)

• agitation and aggressiveness within hospital

  measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation

  baseline and hospital discharge discharge (up to one week)

• behavioural and psychological symptoms of dementia

  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

  baseline, discharge (up to one week)

• agitation and aggressiveness outside hospital

  Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation

  baseline, 1 and 4 weeks after discharge

Secondary Outcomes (5)

• incidence of delirium

  every day during hospital stay (up to one week)

• patients' quality of life

  baseline and 4 weeks after discharge

• family caregivers' quality of life

  baseline and 4 weeks after discharge

• professional caregiver burden

  baseline and at hospital discharge (up to one week)

• family caregiver burden

  baseline and 4 weeks after discharge

Study Arms (2)

doll therapy

EXPERIMENTAL

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

Other: doll therapy

non anthropomorphic object

OTHER

non- anthropomorphic soft object

Other: doll therapy

Interventions

doll therapy OTHER

empathy dolls

doll therapy; non anthropomorphic object

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

geriatric and Geriatric Rehabilitation Unit

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (5)

• Martin-Garcia A, Corregidor-Sanchez AI, Fernandez-Moreno V, Alcantara-Porcuna V, Criado-Alvarez JJ. Effect of Doll Therapy in Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Healthcare (Basel). 2022 Feb 23;10(3):421. doi: 10.3390/healthcare10030421.

  PMID: 35326899 BACKGROUND

• Molteni V, Vaccaro R, Ballabio R, Ceppi L, Cantu M, Ardito RB, Adenzato M, Poletti B, Guaita A, Pezzati R. Doll Therapy Intervention Reduces Challenging Behaviours of Women with Dementia Living in Nursing Homes: Results from a Randomized Single-Blind Controlled Trial. J Clin Med. 2022 Oct 24;11(21):6262. doi: 10.3390/jcm11216262.

  PMID: 36362489 BACKGROUND

• James IA, Reichelt K, Shirley L, Moniz-Cook E. Management of Agitation in Behaviours That Challenge in Dementia Care: Multidisciplinary Perspectives on Non-Pharmacological Strategies. Clin Interv Aging. 2023 Feb 18;18:219-230. doi: 10.2147/CIA.S399697. eCollection 2023.

  PMID: 36843632 BACKGROUND

• Peng Y, Liu Y, Guo Z, Zhang Y, Sha L, Wang X, He Y. Doll therapy for improving behavior, psychology and cognition among older nursing home residents with dementia: A systematic review and meta-analysis. Geriatr Nurs. 2024 Jan-Feb;55:119-129. doi: 10.1016/j.gerinurse.2023.10.025. Epub 2023 Nov 19.

  PMID: 37980780 BACKGROUND

• Santagata F, Massaia M, D'Amelio P. The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study. BMC Geriatr. 2021 Oct 12;21(1):545. doi: 10.1186/s12877-021-02496-0.

  PMID: 34641791 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Patrizia D Amelio, MD, PhD

CONTACT

+41213143712; patrizia.damelio@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, head of the geriatric and Geriatric rehabilitation Service

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

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 20, 2023
• Study Start: November 15, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)