Clinical trial NCT06639841: Effectiveness of Virtual Reality Psychotherapy and Yoga on Student Performance Anxiety
Official title: A Comparative Study on the Effectiveness of Virtual Reality-Facilitated Psychotherapy Vs. Yoga-Based Interventions for Managing Performance Anxiety Among Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Performance Anxiety
Keywords: Performance anxiety
Students
Virtual Reality
Yoga
Psychotherapy
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Romanian Academy
name: Socola Institute of Psychiatry
First posted: 2024-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study follows a parallel assignment model, where participants are divided into two distinct groups (arms). Each group will receive a different intervention simultaneously, without crossing over to the other group. The two arms will be independently assessed throughout the study period to compare the effects of the assigned interventions on the participants. This design allows for the direct evaluation of each intervention's impact, ensuring that comparisons can be made between the groups without overlap in treatment or intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this pilot clinical trial is to compare two non-pharmacological interventions-Virtual Reality (VR) and Yoga techniques-in reducing performance anxiety in students aged 16-35. Performance anxiety, commonly experienced during public speaking and examinations, affects academic performance and well-being. The main questions it aims to answer are:

Does the VR-based guided meditation intervention reduce performance anxiety more effectively than Yoga-based relaxation techniques? Do participants experience better emotional regulation and improved quality of life with either intervention? Researchers will compare the VR intervention group to the Yoga intervention group to determine which intervention better alleviates anxiety symptoms and fosters improved emotional regulation during school performance.

Participants will:

Attend six to ten sessions of either VR-based guided meditation or Yoga-based relaxation over a period of four weeks.

Complete questionnaires to assess their anxiety levels, emotional regulation, and quality of life before and after the intervention.

Detailed description: Detailed Description This randomized controlled trial (RCT) is designed to evaluate the comparative effectiveness of two non-pharmacological interventions-Virtual Reality (VR) and Yoga techniques-in reducing performance anxiety among students aged 16-35. Performance anxiety, a specific type of anxiety experienced in academic and public speaking situations, has a significant impact on students' academic performance and overall mental well-being. The study aims to explore accessible, non-invasive interventions that can be easily integrated into educational settings to help manage this condition.

The trial will compare VR-based guided relaxation and exposure therapy, delivered via the Guided Meditation VR software, with Yoga-based relaxation techniques, incorporating Hatha Yoga postures (asanas), breathing exercises (pranayama), and meditation (dhyana). Both interventions focus on providing mental relaxation, emotional regulation, and coping strategies to manage performance-related anxiety without the use of medications.

Rationale:

The choice of interventions is based on evidence supporting both VR and Yoga as effective tools for anxiety reduction. Virtual Reality has been shown to provide immersive environments that enhance relaxation, while allowing exposure to stressful situations in a controlled manner, which is crucial for performance anxiety. Guided Meditation VR enables students to practice mindfulness in virtual settings designed to reduce stress, using calming visuals and guided meditative exercises.

In contrast, Yoga is an ancient practice that has been widely studied for its ability to reduce anxiety through physical movement, controlled breathing, and meditation. By incorporating mindfulness and physical postures, Yoga may promote relaxation and help students improve their ability to regulate their physiological and emotional responses to anxiety-inducing situations.

Study Design:

The study will randomly assign participants to either a VR intervention group or a Yoga intervention group. Both interventions will be delivered over a period of 4 weeks, with 6-10 sessions, each lasting approximately 30-40 minutes. The interventions will be offered in a structured format, with the VR sessions focusing on mindfulness and relaxation in immersive environments, and the Yoga sessions integrating movement, breath control, and meditation.

Each participant's anxiety levels will be measured at baseline, immediately after the intervention, and during a follow-up period to assess the sustained effects of the interventions on anxiety reduction.

Virtual Reality Intervention:

The VR intervention will utilize the Guided Meditation VR software, accessible via VR headsets such as Oculus Quest 2 or HTC Vive Flow. The sessions will involve participants entering virtual environments specifically designed to promote relaxation and mindfulness, such as serene beaches, forests, and mountains. These environments are paired with guided meditation sessions aimed at calming the mind and reducing anxiety. Additionally, participants will be encouraged through guided imagery to engage in public speaking or exam scenarios, while using mindfulness techniques to reduce their anxiety responses. The immersive nature of VR allows participants to practice coping strategies in a safe, controlled setting.

Yoga Intervention:

The Yoga intervention will follow the principles of Hatha Yoga, focusing on practices that have been shown to promote relaxation and reduce anxiety. Sessions will incorporate a combination of physical postures (asanas), breath control exercises (pranayama), and meditation (dhyana). Participants will be guided through a series of gentle yoga postures aimed at reducing physical tension and promoting mental clarity. The breathing techniques and meditation components will focus on calming the mind and regulating the body's stress response, making this intervention particularly relevant for managing performance anxiety.

Feasibility and Acceptability:

In addition to the primary objective of reducing performance anxiety, this study will assess the feasibility and acceptability of integrating these interventions into student life. The ease of implementing VR and Yoga techniques in academic environments will be evaluated, as well as participant feedback on the usability and perceived effectiveness of each intervention.

Significance:

This trial addresses the growing need for accessible mental health interventions that can be seamlessly integrated into educational settings. By exploring the comparative benefits of Virtual Reality and Yoga, the study aims to provide insights into non-pharmacological treatments that may reduce the burden of anxiety on students. The results could inform future interventions that help students manage their mental health and academic performance more effectively.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 35 years;
* Currently enrolled university students or recent graduates (within the last 2 years) pursuing further studies (e.g., Master's or PhD) in the same area of expertise;
* Mild to moderate levels of trait anxiety as measured by validated psychological inventories (e.g., STAI-Y1); Able to fully understand study procedures;
* No prior exposure to the specific interventions being tested (i.e., Virtual Reality Psychotherapy or Yoga interventions);
* Able to provide informed consent to participate in the study.

Exclusion Criteria:

* History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder);
* Currently receiving psychiatric or psychological treatment, including ongoing psychotropic medication;
* History of adverse reactions to Virtual Reality technology (e.g., motion sickness, dizziness, allergy to headset and controllers materials);
* Significant physical limitations preventing participation in yoga exercises;
* Pregnant individuals, due to physical limitations related to yoga and potential psychological sensitivity to Virtual Reality;
* Individuals not fluent in Romanian and English, as the interventions and assessments will be conducted in Romanian, with the Virtual Reality intervention partly in English.

Primary outcomes:
measure: Trait Anxiety Reduction
timeFrame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program and also after major events such as faculty exams.
Secondary outcomes:
measure: State Anxiety Reduction
timeFrame: Measured at baseline, before each session, and 30 minutes after the interventions.
measure: Emotional Regulation Strategies
timeFrame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
measure: Quality of Life Improvement
timeFrame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
Other outcomes:
measure: Performance Anxiety
timeFrame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
measure: Qualitative Intervention Feedback
timeFrame: 60 minutes before and after each intervention.
Locations:
city: Iasi
country: Romania
facility: Romanian Academy of Sciences
Study officials:
affiliation: University of Medicine and Pharmacy "Grigore T. Popa" Iași
name: Marcel A Găină, Ass. Prof.
role: STUDY_CHAIR
affiliation: Romanian Academy of Sciences "Gh. Zane" Institute Iasi
name: Liviu A Măgurianu, Sci.Res.III
role: STUDY_DIRECTOR
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