NCT06506487 · COMPLETED
Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial
Sponsor: University of Malaya
This trial tests whether giving people with dementia a doll to hold and care for can reduce their need for medications, ease behavioral symptoms like agitation or anxiety, and help them with daily activities. It is a Phase NA randomized controlled trial — meaning it is evaluating a non-drug behavioral approach rather than a new medicine, in nursing home residents in China across six facilities.
You may qualify if
- Age 65 years or older.
- Nursing home resident with a documented clinical diagnosis of dementia recorded in the medical or nursing-home record by a qualified physician using DSM-5, ICD-10, ICD-11, or current Chinese clinical guidelines for dementia and cognitive impairment; where the underlying diagnostic criteria were not specified in the record, the site clinician reconfirmed the diagnosis against DSM-5 criteria before enrollment.
- Adequate visual capacity to recognize a doll at screening.
- Sufficient upper-limb function to hold or caress the doll safely.
- Availability of a legally authorized representative able to provide written informed consent.
- Resident assent whenever appropriate.
You're excluded if
- Acute medical instability.
- Severe sensory or physical limitations preventing safe participation.
- Severe communication impairment precluding meaningful participation.
- Major psychiatric disorders unrelated to dementia.
- Resident dissent or refusal when assent was appropriate, or safety concerns that made doll interaction unsuitable.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-13