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IRCT20260623069931N4 IRCT 2026-10-02 Tehran University of Medical Sciences Effect of Gamified Virtual Reality Exercise on Emotional Well-Being in Risk-Averse Older Women A Gamified VR Exercise Approach for Advancing Emotional Health in Risk-Averse Older Women: An Interdisciplinary Examination Based on the Broaden-and-Build Theory 2026-05-30 anticipated 138 Complete https://irct.ir/trial/93712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completion of the baseline assessments and confirmation of eligibility, participants will be randomly allocated to the intervention and control groups in a 1:1 ratio. Simple randomization will be performed at the individual level. The allocation sequence will be generated using a computer-generated random-number sequence by a researcher who will not be involved in participant recruitment or intervention delivery. Allocation will occur only after eligibility confirmation and completion of baseline assessments to reduce allocation bias, Blinding description: Due to the nature of the intervention, participants and researchers responsible for intervention delivery will not be blinded to group allocation. Outcome assessors responsible for collecting and evaluating questionnaire data at baseline, post-intervention, and the 30-day follow-up will be blinded to participants’ allocation to the intervention or control group. Participants will also be instructed not to disclose their group allocation or intervention type to the outcome assessors during assessments. N/A High risk aversion in older women. Intervention group: Participants will complete a 4-week gamified virtual reality exercise program consisting of 12 sessions (3 sessions per week), with each session lasting 30–40 minutes, using Pico 4 Enterprise headsets. Exercises will include balance activities in virtual environments, walking on virtual platforms, balancing on narrow pathways, and simulated gliding activities. Gamification elements will include progressive levels, scoring, immediate feedback, and achievement badges.. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, including baseline characteristics and primary and secondary outcome data, will be available after publication of the study results upon reasonable request from researchers. No personally identifiable information will be shared. When: From 6 months after publication of the study results until 5 years after publication. To whom: Academic and scientific researchers, upon reasonable request and approval by the principal investigator. Conditions: The data and documents will be used only for scientific and research purposes and related analyses. Applicants must provide the research purpose and proposed analysis plan. Access will be granted after approval by the principal investigator and under conditions that ensure participant confidentiality. Where to obtain: Requests should be submitted to Hossein Faridniya, Principal Investigator, by email. Contact telephone: +98 936 387 5989. How to obtain: Requests will be reviewed by the principal investigator. The research purpose, analysis plan, and confidentiality requirements will be assessed. If approved, de-identified data will be provided within 30 days. Comments:
public Hossein Faridniya
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
Tehran Iran (Islamic Republic of) ۵۰۴۱۷۲۱۰۶۸۵۹ +98 21 5566 4102 hossein.faridniya@ut.ac.ir Tehran University of Medical Sciences scientific Hossein Faridniya
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
Tehran Iran (Islamic Republic of) ۵۰۴۱۷۲۱۰۶۸۵۹۳۷۱۵ +98 936 387 5989 hossein.faridniya@ut.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women aged 60–80 years Clinically verified high risk aversion Scores above the predefined cut-off on the Health/Safety and Recreational domains of the DOSPERT scale Sufficient literacy to complete the study questionnaires Adequate physical health to perform light-to-moderate physical activity, confirmed by a physician Willingness to participate and provision of written informed consent 60 years 80 years Female Cardiovascular conditions that will prevent safe participation in the exercise program Musculoskeletal or balance disorders that will prevent safe participation in the exercise program Active major psychiatric conditions, such as psychosis or untreated major depression A history of epilepsy or photosensitivity that will be incompatible with safe use of a virtual reality headset Rehabilitation Intervention group: Participants will complete a 4-week gamified virtual reality exercise program consisting of 12 sessions (3 sessions per week), with each session lasting 30–40 minutes, using Pico 4 Enterprise headsets. Exercises will include balance activities in virtual environments, walking on virtual platforms, balancing on narrow pathways, and simulated gliding activities. Gamification elements will include progressive levels, scoring, immediate feedback, and achievement badges. Overall happiness score measured using the Oxford Happiness Inventory (OHI). Timepoint: At baseline (before the intervention); immediately after the 4-week intervention; 30 days after the intervention (follow-up). Method of measurement: Oxford Happiness Inventory, consisting of 29 items. Positive affect score measured using the Oxford Happiness Inventory. Timepoint: At baseline (before the intervention); immediately after the 4-week intervention; 30 days after the intervention (follow-up). Method of measurement: Oxford Happiness Inventory, consisting of 29 items. Tehran University of Medical Sciences Approved 2025-05-03 Ethics Committee of the Sport Sciences Research Institute (SSRI) No. 3, 5th Alley, Mir Emad St., Ostad Motahari St. Tehran Tehran Iran (Islamic Republic of)