NCT06506487

Effectiveness of Doll Therapy in People With Dementia

Effectiveness of Doll Therapy in People With Dementia: A Mixed Method Research Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-07-17
• Last updated: 2025-05-16

Locations

1 site across 1 country: China