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Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial
Sponsor: University of Malaya
Summary
This study is a two-phase explanatory sequential mixed-methods study in Chinese residential dementia care. Phase I is a pragmatic 1:1 exploratory pilot cluster randomized trial in six nursing homes in Zhengzhou, China, comparing staff-mediated doll therapy plus routine nursing care with routine nursing care alone among 142 residents with dementia assessed at baseline, 6 weeks, and 12 weeks. Registered primary outcomes are class-specific daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants. Secondary and contextual outcomes include behavioral and psychological symptoms of dementia, activities of daily living, cognitive enhancer use, traditional Chinese medicine use, and doll engagement/adherence. Phase II uses semi-structured interviews with staff and family caregivers to explore acceptability, implementation, training needs, cultural fit, and ethical considerations.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-07-31
Completion Date
2025-12-31
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Doll Therapy
Staff-mediated doll therapy is a person-centered, attachment-informed non-pharmacological care package in which trained nursing-home staff introduce a lifelike doll respectfully, support resident-led interaction, monitor assent and dissent, and provide continued access to a personal doll during routine care. The intervention included eight planned introductory sessions over approximately 15 days, structured interaction, relational engagement, and implementation within ordinary nursing-home care.
Locations (1)
Sias University
Zhengzhou, Henan, China