Mental Health IssueNCT06480409
**Virtual Reality in Student Mental Health: Solution or White Elephant?**
A study testing VR Mindfulness and Stress Reduction Program in people with Mental Health Issue, run by The Opole University of Technology at 1 site in Poland.
Trial summary
The COVID-19 pandemic drastically altered social structures, leading to prolonged isolation and remote learning for students, causing significant mental health issues. This project at Opole University of Technology aims to address these challenges through a virtual reality (VR)-based therapeutic program. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- VR Mindfulness and Stress Reduction Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jun 2023to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- acceptance to participate in the research
- age 19-30
Who cannot join
- diagnosed neurological diseases,
- fear of wearing goggles
- diagnosed diseases or injuries of the musculoskeletal system
Trial locations and contacts
1 site in 1 country.
Poland1 site
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
About this study
Official title: Program for Improving Students' Mental Health Using Virtual Reality - a Solution or a White Elephant?
The COVID-19 pandemic drastically altered social structures, leading to prolonged isolation and remote learning for students, causing significant mental health issues. This project at Opole University of Technology aims to address these challenges through a virtual reality (VR)-based therapeutic program.
Objectives:
Read more
The project will utilize immersive VR technology to conduct relaxation sessions, creating a dedicated relaxation room equipped with VR headsets and physiological sensors. The goal is to assess the impact of VR-based therapy on students' autonomic nervous system and psychological well-being.
Key Hypotheses:
VR relaxation sessions will induce physiological relaxation. A 15-minute VR session will not cause cybersickness. Weekly VR sessions will reduce stress levels among students.
Methodology:
Using Polar H-10 sensors, the project will measure heart rate variability (HRV) to evaluate autonomic responses. Psychological stress will be monitored using the Perceived Stress Scale (PSS-10). A sample size of 50 participants, calculated with G*Power software, will be studied using repeated measures ANOVA.
Read the detailed description
Project Objective and Scope:
The COVID-19 pandemic, declared by the World Health Organization in March 2020, significantly altered social structures globally. In Poland, the pandemic led to prolonged periods of physical isolation and remote learning for students, disrupting conventional educational routines and causing elevated levels of loneliness and mental health issues, particularly depression. Research indicates that 30% of students exhibited symptoms of depression, and 50% experienced heightened stress during the pandemic. This project aims to address these mental health challenges by implementing a virtual reality (VR)-based therapeutic program for students at Opole University of Technology.
Project Description:
The proposed project focuses on using immersive VR technology to conduct relaxation sessions for students. The initiative will create a relaxation room equipped with VR headsets and physiological sensors to monitor students' responses during VR sessions. The primary goal is to evaluate the impact of VR-based relaxation therapy on the autonomic nervous system and psychological well-being of students.
Specific Objectives:
Implementing VR in Medical Practice:
VR technology has proven effective in various medical fields, including surgery, rehabilitation, and mental health. This project will leverage immersive VR to create an engaging and effective therapeutic environment. The therapy sessions will be conducted using portable VR headsets, providing students with an immersive experience that isolates them from real-world stressors.
Scientific Analysis:
Physiological data will be collected using Polar H-10 sensors to assess heart rate variability (HRV), a measure of autonomic nervous system activity. This data will help determine the effectiveness of different VR scenarios in inducing relaxation and improving mental well-being. The project will also monitor psychological changes using the Perceived Stress Scale (PSS-10).
Methodology:
A sample size of 50 participants has been calculated based on previous studies using G*Power software. The study will use repeated measures ANOVA to analyze the data, ensuring robust statistical analysis. The project also plans to promote participation through local media, aiming to include students from various higher education institutions in the Opole region.
- Conditions
- Mental Health Issue
- Being tested
- VR Mindfulness and Stress Reduction Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Mindfulness and Stress Reduction ProgramOther
Intervention Procedure:
Duration and Frequency: Participants will engage in 15-minute VR relaxation sessions, held five times a week over a period of one month.
VR Content: The VR sessions will feature high-quality 360° videos with therapeutic audio, including guided relaxation, calming music, and nature sounds.
Physiological Monitoring: Throughout the sessions, participants' physiological responses will be monitored using Polar H-10 sensors to measure heart rate variability (HRV), providing data on autonomic nervous system activity.
Psychological Assessment: Participants will complete the Perceived Stress Scale (PSS-10) before and after the intervention to evaluate changes in stress levels.
Cybersickness Monitoring: The occurrence of any adverse effects, such as cybersickness, will be monitored and recorded.
| Study group | Role | What they receive |
|---|---|---|
| VR-based intervention | Experimental | The intervention group will participate in a structured VR-based relaxation program designed to improve mental health and reduce stress levels. The sessions will take place in a dedicated relaxation room equipped with immersive VR headsets and physiological sensors.
Intervention Procedure:
Duration and Frequency: Participants will engage in 15-minute VR relaxation sessions, held five times a week over a period of one month.
VR Content: The VR sessions will feature high-quality 360° videos with therapeutic audio, including guided relaxation, calming music, and nature sounds. Receives: Other: VR Mindfulness and Stress Reduction Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Relaxation
Participants will be monitored via heart rate variability (HRV) indicating a balanced autonomic nervous system response.
Measured: 20 min
Stress Levels
Participants will be examined by the Perceived Stress Scale (PSS-10).
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start5 Jun 2023
- Primary completion5 Sep 2023
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480409
- Sponsor's protocol ID
- Opole
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for Improving Students' Mental Health Using Virtual Reality - a Solution or a White Elephant?
- ClinicalTrials.gov ID
- NCT06480409
- Acronym / sponsor ID
- Opole
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic drastically altered social structures, leading to prolonged isolation and remote learning for students, causing significant mental health issues. This project at Opole University of Technology aims to address these challenges through a virtual reality (VR)-based therapeutic program.
Objectives:
The project will utilize immersive VR technology to conduct relaxation sessions, creating a dedicated relaxation room equipped with VR headsets and physiological sensors. The goal is to assess the impact of VR-based therapy on students' autonomic nervous system and psychological well-being.
Key Hypotheses:
VR relaxation sessions will induce physiological relaxation. A 15-minute VR session will not cause cybersickness. Weekly VR sessions will reduce stress levels among students.
Methodology:
Using Polar H-10 sensors, the project will measure heart rate variability (HRV) to evaluate autonomic responses. Psychological stress will be monitored using the Perceived Stress Scale (PSS-10). A sample size of 50 participants, calculated with G*Power software, will be studied using repeated measures ANOVA.
Detailed description
Project Objective and Scope:
The COVID-19 pandemic, declared by the World Health Organization in March 2020, significantly altered social structures globally. In Poland, the pandemic led to prolonged periods of physical isolation and remote learning for students, disrupting conventional educational routines and causing elevated levels of loneliness and mental health issues, particularly depression. Research indicates that 30% of students exhibited symptoms of depression, and 50% experienced heightened stress during the pandemic. This project aims to address these mental health challenges by implementing a virtual reality (VR)-based therapeutic program for students at Opole University of Technology.
Project Description:
The proposed project focuses on using immersive VR technology to conduct relaxation sessions for students. The initiative will create a relaxation room equipped with VR headsets and physiological sensors to monitor students' responses during VR sessions. The primary goal is to evaluate the impact of VR-based relaxation therapy on the autonomic nervous system and psychological well-being of students.
Specific Objectives:
Implementing VR in Medical Practice:
VR technology has proven effective in various medical fields, including surgery, rehabilitation, and mental health. This project will leverage immersive VR to create an engaging and effective therapeutic environment. The therapy sessions will be conducted using portable VR headsets, providing students with an immersive experience that isolates them from real-world stressors.
Scientific Analysis:
Physiological data will be collected using Polar H-10 sensors to assess heart rate variability (HRV), a measure of autonomic nervous system activity. This data will help determine the effectiveness of different VR scenarios in inducing relaxation and improving mental well-being. The project will also monitor psychological changes using the Perceived Stress Scale (PSS-10).
Methodology:
A sample size of 50 participants has been calculated based on previous studies using G*Power software. The study will use repeated measures ANOVA to analyze the data, ensuring robust statistical analysis. The project also plans to promote participation through local media, aiming to include students from various higher education institutions in the Opole region.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-based intervention | Experimental | Other: VR Mindfulness and Stress Reduction ProgramThe intervention group will participate in a structured VR-based relaxation program designed to improve mental health and reduce stress levels. The sessions will take place in a dedicated relaxation room equipped with immersive VR headsets and physiological sensors. Intervention Procedure: Duration and Frequency: Participants will engage in 15-minute VR relaxation sessions, held five times a week over a period of one month. VR Content: The VR sessions will feature high-quality 360° videos with therapeutic audio, including guided relaxation, calming music, and nature sounds. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- acceptance to participate in the research
- age 19-30
Key exclusion criteria (3 listed)
- diagnosed neurological diseases,
- fear of wearing goggles
- diagnosed diseases or injuries of the musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Mindfulness and Stress Reduction ProgramIntervention Procedure: Duration and Frequency: Participants will engage in 15-minute VR relaxation sessions, held five times a week over a period of one month. VR Content: The VR sessions will feature high-quality 360° videos with therapeutic audio, including guided relaxation, calming music, and nature sounds. Physiological Monitoring: Throughout the sessions, participants' physiological responses will be monitored using Polar H-10 sensors to measure heart rate variability (HRV), providing data on autonomic nervous system activity. Psychological Assessment: Participants will complete the Perceived Stress Scale (PSS-10) before and after the intervention to evaluate changes in stress levels. Cybersickness Monitoring: The occurrence of any adverse effects, such as cybersickness, will be monitored and recorded. | Other | VR-based intervention |
Primary outcome
Physiological Relaxation
Time frame: 20 min
Participants will be monitored via heart rate variability (HRV) indicating a balanced autonomic nervous system response.
Stress Levels
Time frame: 10 min
Participants will be examined by the Perceived Stress Scale (PSS-10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Mindfulness and Stress Reduction Program in people with Mental Health Issue, run by The Opole University of Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Relaxation (time frame: 20 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.