This study is aimed at identifying the effect of doll therapy on agitation and cognitive state in institutionalized patients with moderate-to-severe dementia. This randomized controlled experimental study was conducted from April 8, 2019, to October 30, 2019, in a nursing home in Aksaray, Turkey. In total, 29 people with dementia participated in this study, 15 of whom comprised the intervention group. The control group, in which no intervention was made, was composed of the remaining 14 individuals. Data were collected using the introductory information form and the Standardized Mini-Mental State Examination (SMMSE) to evaluate cognitive status, and the Neuropsychiatric Inventory (NPI) and Cohen-Mansfield Agitation Inventory (CMAI) to evaluate behavioral disturbances. Patients with dementia in the intervention group received doll therapy for 8 weeks. We found that there was no statistically significant change between fourth- and eighth-week SMMSE scores for either the intervention or control groups ( P > .05), while there was a significant change in the CMAI and NPI scores of the intervention group ( P < .05). This study found that doll therapy was effective in decreasing agitation and behavioral problems in people diagnosed with moderate-to-severe dementia. Trial registration: ClinicalTrials.gov , ID: NCT04120103 Retrospectively registered on 8 April 2019.