Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2023-10-14
2024-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This quasi-experimental study investigates the effectiveness of a gamified sports exercise intervention delivered through virtual reality (VR) to improve mental health and life expectancy in elderly individuals aged 60 and over who are experiencing suicidal thoughts. The study aims to address the following research questions:
How do gamified sports exercises in a virtual reality environment impact the mental health of elderly individuals with suicidal thoughts? What differences in mental health outcomes are observed between participants engaging in gamified VR exercises and those participating in conventional sports exercises?
The study design involves two groups:
Experimental Group: Participants will engage in VR-based sports training sessions that incorporate gamification elements, such as rewards, competition, and interactive challenges.
Control Group: Participants will participate in traditional sports exercises without gamification or VR components.
Procedures:
Baseline Assessment: All participants will complete a life expectancy questionnaire and standardized mental health assessments to establish baseline data.
Intervention:
The experimental group will undergo a series of VR-based sports training sessions, designed to be engaging and immersive, with gamified elements to enhance motivation and adherence.
The control group will participate in conventional sports exercises, such as light aerobic activities or stretching, delivered in a standard, non-gamified format.
Post-Intervention Assessment: Mental health outcomes, including changes in suicidal ideation, life satisfaction, and overall well-being, will be evaluated using validated questionnaires and scales.
Expected Outcomes:
The study hypothesizes that the experimental group will demonstrate significant improvements in mental health outcomes, including reduced suicidal ideation and increased life satisfaction, compared to the control group. The findings aim to provide evidence-based insights into the potential of gamified VR interventions as a non-pharmacological strategy to enhance the well-being of elderly individuals at risk for suicide.
This study contributes to the growing body of research on innovative approaches to mental health support for vulnerable populations, with a focus on leveraging technology to improve quality of life and reduce suicide risk among the elderly.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trajectories for Active and Healthy Aging
NCT06939621
Improving Sports and Recreation Services in Mashhad for Elderly and Intergenerational Interaction (ESPIRE-M)
NCT06860126
The Effect of Nature and Game Based Activities on Older People
NCT06609408
Olfaction, Virtual Reality and Art in Health
NCT05292703
Comparison of Effects of Interactive Video Games in the Elderly
NCT03175588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background Aging is associated with an increased incidence of chronic diseases and mental health issues, including depression and suicidal ideation. Elderly individuals (aged 60 and over) represent a vulnerable population at heightened risk for suicide. Research indicates that physical activity plays a crucial role in improving both mental and physical health outcomes. However, many elderly individuals encounter significant barriers to regular participation in physical exercises, such as low motivation and limited access to facilities.
Emerging technologies, such as gamification and virtual reality (VR), have shown promise in enhancing engagement in health-related behaviors. Gamification-integrating game-like elements into non-game contexts-has been recognized as a potent tool to motivate individuals to participate in physical activities. VR offers an immersive experience that may further enhance the appeal of physical exercises for older adults.
Purpose This study aims to evaluate the effectiveness of a gamified sports exercise program in a virtual reality environment as a means to improve mental health and life satisfaction among elderly individuals experiencing suicidal ideation. The intervention seeks to create an engaging and supportive environment to reduce suicidal ideation and increase overall life satisfaction within this demographic.
Study Design This is a quasi-experimental study with pre-test and post-test assessments. Participants will be randomly assigned to either an experimental group that engages in VR-based sports exercises or a control group that participates in conventional sports activities without gamified elements.
Intervention
Participants in the experimental group will engage in sports exercises designed in a virtual reality environment, incorporating gamification elements to enhance engagement. The intervention includes:
Structured virtual reality sports sessions guided by trained facilitators.
Gamified features such as rewards, points, and friendly competition to stimulate motivation.
Social interaction elements where participants can engage with each other during sessions to foster community and support.
The control group will participate in traditional physical activity sessions without VR or gamification.
Assessments
Baseline assessments will be conducted before the interventions, with follow-up assessments after the 8-week intervention period. The following tools will be utilized:
Life Expectancy Questionnaire: A validated tool to assess participants' perceptions of their future and overall well-being.
Suicidal Ideation Scale: A standard scale to measure the severity of suicidal thoughts.
Depression Inventory: To assess levels of depressive symptoms before and after the intervention.
Data Analysis Data will be analyzed using appropriate statistical methods to assess the effectiveness of the gamified sports exercise program compared to conventional exercises. Primary outcomes will focus on changes in mental health indicators, including suicidal ideation, life expectancy perceptions, and overall quality of life.
Expected Outcomes
The study anticipates that participation in the gamified virtual reality sports exercises will lead to:
A significant reduction in suicidal thoughts and depressive symptoms among participants.
Improved perceptions of life expectancy among elderly individuals.
Higher rates of physical activity engagement in the experimental group compared to the control group.
Significance The findings of this study are expected to contribute valuable knowledge to the field of elderly mental health, particularly for strategies aimed at reducing suicide risks. By addressing the interplay of mental health and physical activity, the research aims to provide evidence for innovative intervention strategies that can enhance the quality of life for vulnerable elderly populations.
Ethical Considerations The study will adhere to ethical guidelines for research. Informed consent will be obtained from all participants (or their guardians) before enrollment, ensuring they fully understand the study's purpose, procedures, and their right to withdraw at any time.
Key Changes:
Removed Duplicate Information:
Removed eligibility criteria and sample size details, as these are recorded in other data elements.
Focused on providing extended technical details about the intervention, assessments, and data analysis.
Technical and Extended Description:
Added more technical details about the VR-based sports exercises, gamification elements, and assessment tools.
Ensured the description aligns with the protocol's purpose and design without repeating information from other sections.
Improved Flow and Readability:
Organized content into clear sections for better readability and alignment with protocol requirements.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
The intervention aims to enhance physical activity engagement through an interactive and supportive environment, fostering community and social interaction among participants. Data will be gathered through baseline assessments and follow-up evaluations to gauge changes in mental health indicators, including suicidal ideation and perceived life expectancy.
PREVENTION
DOUBLE
Additionally, researchers conducting the data analysis will also remain blinded to group allocations to ensure objective evaluation of results and reduce any potential biases during interpretation. This masking approach is designed to preserve the integrity of the study findings and ensure that the effects of the intervention are accurately attributed to the gamified VR sports exercises.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gamified Virtual Reality Sports Exercise Program for Elderly Individuals with Suicidal Thoughts
Participants will engage in a gamified virtual reality (VR) sports exercise program specifically designed for elderly individuals experiencing suicidal thoughts. The intervention consists of structured, immersive VR sessions that incorporate various sports activities tailored to accommodate the physical abilities of the participants. These sessions will utilize gamification elements, including points, rewards, and friendly competition, to enhance motivation and engagement.
Participants will join weekly VR exercise sessions guided by trained facilitators who will provide support and encouragement throughout the program. The aim is to foster social interaction among participants, creating a sense of community and reducing feelings of loneliness. Each session will last approximately 60 minutes and will include warm-up exercises, the main VR activity, and a cooldown
Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts
participants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement.
The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected.
Active Comparator: Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thought
Participants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement.
The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected.
Behavioral: Traditional Sports Exercise Program Structured physical activity sessions led by experienced facilitators. Low-impact sports and exercises tailored for older adults.
Gamified Virtual Reality Sports Exercise Program
Participants in the experimental group will participate in a variety of sports exercises designed in a virtual reality environment utilizing gamification elements to enhance engagement. The intervention will include:
* Structured virtual reality sports sessions guided by specially trained facilitators.
* Use of gamified features such as rewards, points, and friendly competition to stimulate motivation.
* Incorporation of social elements where participants can interact with each other during sessions to foster community and support.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gamified Virtual Reality Sports Exercise Program
Participants in the experimental group will participate in a variety of sports exercises designed in a virtual reality environment utilizing gamification elements to enhance engagement. The intervention will include:
* Structured virtual reality sports sessions guided by specially trained facilitators.
* Use of gamified features such as rewards, points, and friendly competition to stimulate motivation.
* Incorporation of social elements where participants can interact with each other during sessions to foster community and support.
Traditional Sports Exercise Program for Elderly Individuals with Suicidal Thoughts
participants will engage in a traditional sports exercise program aimed at elderly individuals experiencing suicidal thoughts. The intervention consists of structured physical activity sessions that include a variety of low-impact sports and exercises designed for older adults. These activities will be conducted in a supportive group setting to foster social interaction and community engagement.
The sessions will be led by experienced facilitators who specialize in elderly fitness and mental health. Each session will last approximately 60 minutes and will include a warm-up, the main exercise component, and a cooldown period to promote physical well-being and relaxation. Participants will be encouraged to engage at their own pace, ensuring that individual capabilities and comfort levels are respected.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suicidal thoughts confirmed by psychological evaluation
* Symptoms of depression and loneliness
* Informed consent provided by participant or family
* Residency in Tehran, Iran
Exclusion Criteria
* Current therapeutic interventions for suicidal ideation or mental health issues
* Acute medical conditions requiring immediate attention
* History of severe substance abuse or dependence
* Significant physical disabilities preventing basic physical activity
58 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Islamic Azad University, Sanandaj
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zinat Ebrahimi
Assistant Professor, Department of Physical Education and Sport Science
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zinat Dr Zinat Ebrahimi, Professor
Role: PRINCIPAL_INVESTIGATOR
Islamic Azad University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Physical Education and Sport Science, Faculty of Humanities and Literature, Sanandaj Branch, Islamic Azad University, Sanandaj, Iran.
Sanandaj, Kurdistan Province, Iran
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chambers, L.W. and L.W. Chambers, Prevalence and monetary costs of dementia in Canada. 2016: Miscellaneous Agency.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VR-LIFE-SI-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.