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.

中文翻译：

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玩偶疗法对中度至重度痴呆症住院患者躁动和认知状态的影响：一项随机对照研究。

本研究旨在确定玩偶疗法对中度至重度痴呆症住院患者的躁动和认知状态的影响。这项随机对照实验研究于 2019 年 4 月 8 日至 2019 年 10 月 30 日在土耳其阿克萨赖的一家疗养院进行。总共有 29 名痴呆症患者参与了这项研究，其中 15 人为干预组。未进行干预的对照组由其余 14 人组成。使用介绍性信息表和标准化简易精神状态检查 (SMMSE) 收集数据以评估认知状态，并使用神经精神量表 (NPI) 和科恩-曼斯菲尔德激动量表 (CMAI) 来评估行为障碍。干预组的痴呆患者接受了8周的娃娃疗法。我们发现，无论是干预组还是对照组，第 4 周和第 8 周 SMMSE 得分之间都没有统计学上的显着变化。P > .05），而干预组的 CMAI 和 NPI 评分有显着变化（P < .05）。这项研究发现，玩偶疗法可有效减少被诊断为中度至重度痴呆症的人的躁动和行为问题。

试用注册：

ClinicalTrials.gov，ID：NCT04120103 于 2019 年 4 月 8 日追溯注册。