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ArticleFrontiers in public health2026

Doll therapy in residential dementia care in China: protocol for an exploratory pilot and feasibility mixed-methods cluster randomized controlled trial.

Zhenti Cui, Rongrong Guan, Tianrui Xue, Yongchang Sun, Maw Pin Tan, Mas Ayu Said, Yingdong Cao

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Frontiers in public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06506487 (Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06506487 nacompletednot on this map

Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial

TypeinterventionalSponsorUniversity of MalayaRan2024 to 2025Enrolled142ConditionsDementiaArmsDoll Therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Zhenti CuiSchool of Medicine, Sias University, Zhengzhou, Henan, China.
Rongrong GuanSchool of Art and Design, Zhengzhou University of Industrial Technology, Zhengzhou, Henan, China.
Tianrui XueSchool of Medicine, Sias University, Zhengzhou, Henan, China.
Yongchang SunSchool of Medicine, Sias University, Zhengzhou, Henan, China.
Maw Pin TanDivision of Geriatric Medicine, Department of Medicine, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Mas Ayu SaidDepartment of Social and Preventive Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Yingdong CaoSchool of Medicine, Sias University, Zhengzhou, Henan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Behavioral and psychological symptoms of dementia commonly drive psychotropic prescribing in residential care. Doll therapy is a person-centered, attachment-informed intervention that may reduce distress and support engagement, but evidence from Chinese nursing homes remains limited. This protocol describes an exploratory pilot and feasibility mixed-methods cluster randomized controlled trial of a staff-mediated doll-therapy care package plus routine nursing care versus routine nursing care alone. Methods and analysis: Phase I is a pragmatic, parallel-group, 1:1 cluster randomized pilot trial in six nursing homes in Zhengzhou, China, targeting 142 residents with dementia. Intervention homes will receive a structured doll-therapy introduction of eight planned sessions over approximately 15 days, continued access to a personal doll during routine care, staff training, structured interaction, relational engagement, and routine-care implementation; control homes will provide routine nursing care alone. Assessments occur at baseline, 6 weeks, and 12 weeks. The registered primary outcome is class-specific mean daily medication dose over 12 weeks for antipsychotics, anxiolytics, and antidepressants, interpreted as an indirect medication-stewardship signal. The main proximal clinical outcome is total Neuropsychiatric Inventory-12 score. Secondary and contextual outcomes include Barthel Index, cognitive enhancer use, traditional Chinese medicine use, and structured engagement with the doll. Phase II uses semi-structured interviews with staff and family caregivers from intervention homes to examine acceptability, implementation, training needs, cultural fit, and ethical considerations. Quantitative analyses will emphasize effect estimates, confidence intervals, cluster-level summaries, and randomization/permutation-based robustness checks; qualitative data will be analyzed thematically. Discussion: The study will provide feasibility, acceptability, fidelity, safety, preliminary clinical-signal, and implementation evidence to inform a future adequately powered cluster trial in Chinese residential dementia care. Trial registration: https://clinicaltrials.gov/study/NCT06506487, ClinicalTrials.gov, NCT06506487. Registered July 16, 2024.

Indexed as

DementiaNursing HomesPlay TherapyChinaFeasibility StudiesFemaleHumansMaleNursing Home ResidentsPilot ProjectsPragmatic Clinical Trials as TopicRandomized Controlled Trials as Topicactivities of daily livingChinacluster randomized controlled trialdementiadoll therapynursing homespsychotropic medications

Identifiers

PMID42465631
PMCPMC13372967

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.