Effectiveness of Doll Therapy in People With Dementia

NCT06506487 | Active Not Recruiting

• 1 other identifier: LL20240509
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of doll therapy in reducing the daily dose of medications (DDM), behavioral and psychological symptoms of dementia (BPSD), and improving the activities of daily living (ADL) in people living with dementia (PLwD) in residential care facilities in China. The study employs a cluster randomized controlled trial design, involving 142 participants from six nursing homes, divided into an intervention group receiving doll therapy plus routine nursing care and a control group receiving routine nursing care alone. Additionally, the study will explore the experiences and perceptions of staff and family caregivers through qualitative research methods to provide a comprehensive understanding of the intervention's impact.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Daily Dose of Medication (DDM)

  This primary outcome measure will assess the effectiveness of doll therapy in altering the daily dose of medications (DDM) required by participants. The daily dose of medications includes antipsychotics, antidepressants, anxiolytics, and cognitive enhancers, converted to standardized doses (e.g., chlorpromazine equivalents for antipsychotics, diazepam equivalents for anxiolytics, donepezil equivalents for cognitive enhancers, and defined daily dose (DDD) for antidepressants). The change in medication dosage will be measured and compared between the intervention group (doll therapy plus routine care) and the control group (routine care alone).

  12 weeks

Secondary Outcomes (2)

• Change in Behavioral and Psychological Symptoms of Dementia (BPSD)

  12 weeks

• Change in Activities of Daily Living (ADL)

  12 weeks

Study Arms (2)

Doll Therapy plus Routine Nursing Care

EXPERIMENTAL

Participants in this arm will receive doll therapy sessions in addition to routine nursing care. Doll therapy involves the use of lifelike dolls to provide comfort and reduce behavioral and psychological symptoms in people with dementia. The therapy includes activities such as holding, dressing, and interacting with the dolls under the guidance of trained caregivers. Routine nursing care will include standard care practices without additional non-pharmacological interventions.

Behavioral: Doll Therapy

Routine Nursing Care

NO INTERVENTION

Participants in this arm will receive routine nursing care without any additional interventions. Routine nursing care includes standard care practices as provided in the residential care facilities, focusing on the overall well-being and daily needs of the participants.

Interventions

Doll Therapy BEHAVIORAL

Doll therapy involves the use of lifelike dolls to provide comfort and reduce behavioral and psychological symptoms in people with dementia. The therapy includes activities such as holding, dressing, and interacting with the dolls under the guidance of trained caregivers.

Doll Therapy plus Routine Nursing Care

Eligibility Criteria

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

You may qualify if:

• Participants must be at least 65 years old.
• Documented diagnosis of dementia.
• Sufficient manual dexterity to hold or caress a doll.
• Sufficient visual acuity to recognize a doll.
• Must have legal family members or next of kin to sign the consent form.

You may not qualify if:

• Individuals with mild dementia who do not accept the doll after two attempts.
• Participants who accept the doll but leave it within two weeks.
• Individuals without the capacity to give informed consent and without a legal representative to provide consent on their behalf.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sias University

Zhengzhou, Henan, 451100, China

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhenti Cui

  Social and Preventive Medicine, Malaya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 months to 5 years following article publication
• Access Criteria: Requestors will need to sign a data access agreement.

Locations

CN (1)