Doll Therapy on Patients With Moderate and Severe Dementia (NCT04120103) | Clinical Trial Compass
CompletedNot Applicable
Doll Therapy on Patients With Moderate and Severe Dementia
Turkey (Türkiye)29 participantsStarted 2019-04-08
Plain-language summary
Doll therapy is one of the non-pharmacological methods that can be practiced in managing the symptoms of dementia patients. Nurses can practice doll therapy independently, and literature reports that it has positive effects on the behaviors, moods, emotions, cognitive states and social life of patients with moderate and severe dementia. Our country had no study that investigated the effect of doll therapy in managing the cognitive and behavioral symptoms of dementia patients. This project is a randomized controlled trial that aims to investigate the effect of Doll therapy on the cognitive states and agitation levels of patients with moderate and severe dementia.
Who can participate
Age range
90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with moderate to severe dementia (those with a SMMT score of 17 or less)
* Having dexterity to hold or caress a baby
* No problem with communication obstruction
* Dementia patients who agree to participate in the study
Exclusion Criteria:
* Mild stage dementia,
* Diagnosed with neurological or psychiatric diseases other than dementia, not accepting the baby despite two attempts,
* Rarely agitated dementia patients with baby dolls
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Standardized Mini Mental Test
Timeframe: 2 months after the beginning intervention.
2
Cohen-Mansfield Agitation Inventory
Timeframe: 2 months after the beginning intervention
Trial details
NCT IDNCT04120103
SponsorAksaray University Training and Research Hospital