**Virtual Reality in Student Mental Health: Solution or White Elephant?**

June 24, 2024 updated by: The Opole University of Technology

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:

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Opole, Poland, 45-758
        • Faculty of Physical Education and Physiotherapy, Opole University of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • acceptance to participate in the research
  • age 19-30

Exclusion Criteria:

  • diagnosed neurological diseases,
  • fear of wearing goggles
  • diagnosed diseases or injuries of the musculoskeletal system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VR-based intervention

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.
Other: VR Mindfulness and Stress Reduction Program

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physiological Relaxation
Time Frame: 20 min
Participants will be monitored via heart rate variability (HRV) indicating a balanced autonomic nervous system response.
20 min
Stress Levels
Time Frame: 10 min
Participants will be examined by the Perceived Stress Scale (PSS-10).
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Opole University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Opole

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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