{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T15:11:07Z","timestamp":1788448267779,"version":"build-2803163510"},"reference-count":37,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T00:00:00Z","timestamp":1782950400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u202fdays, 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\u202fweeks, and 12\u202fweeks. The registered primary outcome is class-specific mean daily medication dose over 12\u202fweeks 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/study\/NCT06506487<\/jats:ext-link>\n                      ,\n                      <jats:ext-link>ClinicalTrials.gov<\/jats:ext-link>\n                      , NCT06506487. Registered July 16, 2024.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fpubh.2026.1842340","type":"journal-article","created":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T05:34:50Z","timestamp":1782970490000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Doll therapy in residential dementia care in China: protocol for an exploratory pilot and feasibility mixed-methods cluster randomized controlled trial"],"prefix":"10.3389","volume":"14","author":[{"given":"Zhenti","family":"Cui","sequence":"first","affiliation":[{"name":"School of Medicine, Sias University","place":["Zhengzhou, Henan, China"]},{"name":"Department of Social and Preventive Medicine, Universiti Malaya","place":["Kuala Lumpur, Malaysia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongrong","family":"Guan","sequence":"additional","affiliation":[{"name":"School of Art and Design, Zhengzhou University of Industrial Technology","place":["Zhengzhou, Henan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianrui","family":"Xue","sequence":"additional","affiliation":[{"name":"School of Medicine, Sias University","place":["Zhengzhou, Henan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongchang","family":"Sun","sequence":"additional","affiliation":[{"name":"School of Medicine, Sias University","place":["Zhengzhou, Henan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maw Pin","family":"Tan","sequence":"additional","affiliation":[{"name":"Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine, Universiti Malaya","place":["Kuala Lumpur, Malaysia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mas Ayu","family":"Said","sequence":"additional","affiliation":[{"name":"Department of Social and Preventive Medicine, Universiti Malaya","place":["Kuala Lumpur, Malaysia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingdong","family":"Cao","sequence":"additional","affiliation":[{"name":"School of Medicine, Sias University","place":["Zhengzhou, Henan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,7,2]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1016\/j.jalz.2012.11.007","article-title":"The global prevalence of dementia: a systematic review and metaanalysis","volume":"9","author":"Prince","year":"2013","journal-title":"Alzheimers Dement"},{"key":"ref2","year":"2025"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"2308","DOI":"10.1212\/WNL.44.12.2308","article-title":"The neuropsychiatric inventory: comprehensive assessment of psychopathology in 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