Effectiveness of Doll Therapy in People With Dementia

NCT ID: NCT06506487

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

Doll therapy, recognized as a non-pharmacological intervention, involves providing lifelike baby dolls to individuals with dementia to elicit positive emotional responses and behaviors. Despite its potential benefits, evidence supporting its efficacy and acceptability remains limited and inconclusive. This mixed-method research study will conduct a cluster randomized controlled trial to systematically evaluate the effectiveness of doll therapy in reducing the daily dose of medications, mitigating behavioral and psychological symptoms, and enhancing daily living activities among Chinese dementia patients in residential care settings. The trial will involve 142 participants from six nursing homes, randomly assigned to either the intervention group (doll therapy plus routine care) or the control group (routine care only). Quantitative outcomes will be measured using standardized scales for medication use, BPSD, and ADL. In parallel, qualitative data will be collected through interviews with staff and family caregivers to gain insights into their experiences and perceptions of doll therapy. The findings are anticipated to inform best practice guidelines for implementing doll therapy in dementia care.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Doll Therapy plus Routine Nursing Care

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.

Group Type: EXPERIMENTAL

Doll Therapy

Intervention Type: 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.

Routine Nursing Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Doll Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Zhenti Cui

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenti Cui

Role: PRINCIPAL_INVESTIGATOR

Social and Preventive Medicine, Malaya University

Locations

Sias University

Zhengzhou, Henan, China

Countries

China

Other Identifiers

LL20240509

Identifier Type: -

Identifier Source: org_study_id