TY - JOUR AU - Imai, Ayu AU - Matsuoka, Teruyuki AU - Nakayama, Chikara AU - Hashimoto, Nana AU - Sano, Mutsuo AU - Narumoto, Jin PY - 2024 DA - 2024/8/1 TI - Effectiveness of a Virtual Reality Open-Air Bath Program in Reducing Loneliness and Improving Brain Function for Dementia Prevention in Older Adults: Protocol for a Prospective Randomized Crossover Study JO - JMIR Res Protoc SP - e57101 VL - 13 KW - loneliness KW - virtual reality KW - VR KW - Alzheimer disease KW - predementia KW - intervention KW - subjective cognitive decline KW - mild cognitive impairment KW - dementia KW - older adult KW - geriatric KW - depression KW - cognitive impairments AB - Background: Older adults often face loneliness due to chronic illness or loss of close ones, a situation worsened by the COVID-19 pandemic. Increased loneliness heightens the risk of diseases, especially dementia, necessitating urgent action. Objective: This study aims to assess the impact of a virtual reality (VR)–based open-air bath program on depression and loneliness in older individuals with subjective cognitive decline/mild cognitive impairment attending the Dementia Medical Center in Kyoto, Japan. We further aim to evaluate the feasibility of the program (participant recruitment and adherence) and to measure program enjoyment and satisfaction. Methods: The study design is a crossover trial with a 1:1 ratio, wherein 12 participants will be randomly assigned to groups 1 and 2, with group 2 serving as a waitlist control and group 1 receiving the VR program from the onset for 6 months; the VR program will be conducted 6 times (monthly). Program completion for group 1 will be followed by an observation period from months 7 to 12. Group 2 will participate in the VR program from months 7 to 12, with an observation period from months 1 to 6. Cognitive tests, psychiatric assessments, and the University of California, Los Angeles Loneliness Scale will be conducted before the study, at 6 months, and at 12 months. Results will be analyzed using repeated-measures ANOVA. Head magnetic resonance imaging and single-photon emission computed tomography scans will be performed before and after the VR program to evaluate changes and effects on brain regions. Results: Recruitment began in September 2023 and data collection is expected to be completed by March 2025. Complete study results will be published by September 2025. Conclusions: This study examines the preliminary effects of VR on loneliness in older adults with predementia through open-air bath simulations. VR experiences could benefit this population, particularly those with limited outdoor activities. Quantifying VR’s impact will aid in determining the size for a larger clinical trial. Qualitative results will inform participation mechanisms and guide the implementation and design of future trials. Trial Registration: University hospital Medical Information Network UMIN000052667; https://tinyurl.com/3yaccay5 International Registered Report Identifier (IRRID): DERR1-10.2196/57101 SN - 1929-0748 UR - https://www.researchprotocols.org/2024/1/e57101 UR - https://doi.org/10.2196/57101 UR - http://www.ncbi.nlm.nih.gov/pubmed/39088243 DO - 10.2196/57101 ID - info:doi/10.2196/57101 ER -