NCT06506487 · ACTIVE NOT RECRUITING
Effectiveness of Doll Therapy in People With Dementia
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
- 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're excluded 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.
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 2025-05-16