NCT06480409

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 24, 2024

Last Update Submit

June 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physiological Relaxation

    Participants will be monitored via heart rate variability (HRV) indicating a balanced autonomic nervous system response.

    20 min

  • Stress Levels

    Participants will be examined by the Perceived Stress Scale (PSS-10).

    10 min

Study Arms (1)

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.

Other: VR Mindfulness and Stress Reduction Program

Interventions

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.

VR-based intervention

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Education and Physiotherapy, Opole University of Technology

Opole, 45-758, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

June 5, 2023

Primary Completion

September 5, 2023

Study Completion

June 5, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations