Protocol summary

Study aim
The aim of this study will be to evaluate the effectiveness of a gamified virtual reality exercise program in improving emotional health and subjective well-being among risk-averse older women. Specifically, the study will examine whether gamified VR exercise, compared with conventional exercise, can improve overall happiness, positive affect, and life satisfaction while reducing negative affect. The maintenance of these changes will also be assessed at a 30-day follow-up.
Design
A two-arm, parallel, randomized controlled study with 138 participants (69 per group) will be conducted. Participants will be allocated 1:1 using a computer-generated random-number sequence. As a non-drug trial, no clinical trial phase applies. Outcome assessors will be blinded to group allocation.
Settings and conduct
The study will be conducted in psychological service centers and public and private hospitals in Tehran, Iran. After baseline assessment and eligibility confirmation, participants will be randomly allocated to the VR exercise or conventional exercise group. The intervention will include 12 sessions over 4 weeks. Outcome assessors will remain blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion: Women aged 60–80 years with high risk aversion, adequate physical health, and informed consent. Exclusion: Activity-limiting conditions, active major psychiatric disorders, epilepsy, or photosensitivity.
Intervention groups
Intervention group: Gamified VR exercise, 12 sessions over 4 weeks, 30–40 minutes per session. Control group: Conventional balance, agility, and coordination exercises with matched frequency and duration.
Main outcome variables
Overall happiness; Positive affect; Negative affect; Life satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260623069931N4
Registration date: 2026-10-02, 1405/07/10
Registration timing: retrospective

Last update: 2026-10-02, 1405/07/10
Update count: 0
Registration date
2026-10-02, 1405/07/10
Registrant information
Name
Hossein Faridniya
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 936 387 5989
Email address
hossein.faridniya@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-30, 1405/03/09
Expected recruitment end date
2026-06-30, 1405/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Gamified VR Exercise Approach for Advancing Emotional Health in Risk-Averse Older Women: An Interdisciplinary Examination Based on the Broaden-and-Build Theory
Public title
Effect of Gamified Virtual Reality Exercise on Emotional Well-Being in Risk-Averse Older Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Sport Sciences Research Institute (SSRI)
Street address
No. 3, 5th Alley, Mir Emad St., Ostad Motahari St.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-05-03, 1404/02/13
Ethics committee reference number
IR.SSRC.REC.1404.029

Health conditions studied

1

Description of health condition studied
High risk aversion in older women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

Intervention groups

1

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital, Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Street address
Ziaeian Hospital, Abuzar St., Qazvin St.
City
Tehran
Province
Tehran
Postal code
13637635733
Phone
+98 44 4524 3702
Email
solalll.19966@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Saberi
Street address
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
City
Tehran
Province
Tehran
Postal code
1417924570
Phone
+98 21 2625 4102
Email
solalll.19966@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
5
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
City
Tehran
Province
Tehran
Postal code
۵۰۴۱۷۲۱۰۶۸۵۹
Phone
+98 21 5566 4102
Email
hossein.faridniya@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
City
Tehran
Province
Tehran
Postal code
۵۰۴۱۷۲۱۰۶۸۵۹۳۷۱۵
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
University of Tehran, Enghelab-e Eslami Square, Enghelab-e Eslami Ave.
City
Tehran
Province
Tehran
Postal code
5041721068593715
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
From 6 months after publication of the study results until 5 years after publication.
To whom data/document is available
Academic and scientific researchers, upon reasonable request and approval by the principal investigator.
Under which criteria data/document could be used
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.
From where data/document is obtainable
Requests should be submitted to Hossein Faridniya, Principal Investigator, by email. Contact telephone: +98 936 387 5989.
What processes are involved for a request to access data/document
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.
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