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Clinical Trials/NCT06639841
NCT06639841CompletedNot Applicable

A Comparative Study on the Effectiveness of Virtual Reality-Facilitated Psychotherapy vs. Yoga-Based Interventions for Managing Performance Anxiety Among Students

Grigore T. Popa University of Medicine and Pharmacy1 site in 1 country55 target enrollmentStarted: September 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
Trait Anxiety Reduction

Study Overview

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

Only the Outcomes Assessor will be blinded to the group assignments in this study. This masking is employed to avoid measurement bias when comparing the primary and secondary outcomes such that the assessor does not know whether the subject had a Virtual Reality (VR) intervention or Yoga. This approach improves the validity of data collection and measure outcomes.

Because of the distinct and participatory nature of the interventions, VR and Yoga respectively, it is impossible to mask participants, care providers and researchers. This selective blinding approach of masking the Outcomes Assessor aims at an unbiased measure of outcome, despite the practical impossibility of full masking during behavioral and physical interventions.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Virtual Reality facilitated Psychotherapy for Performance Anxiety

Experimental

Participants in this arm will undergo Virtual Reality (VR) facilitated Psychotherapy aimed to alleviate performance anxiety. The sessions will combine cognitive-behavioural therapy (CBT), exposure therapy and relaxation within VR environments. The program will be provided by a qualified integrative psychotherapist, 2-3 times per week, each lasting 30-60 minutes, over 4 weeks. The programme will be individualized for each participant, based on their anxiety levels and progression, including in-depth experiences to promote performance resilience.

Intervention: Virtual Reality Psychotherapy (Device)

Yoga Training for Performance Anxiety

Experimental

Participants in this arm will undergo a Yoga-based intervention for performance anxiety. This therapy includes facilitated yoga sequences consisting of breathing (Pranayama), exercises (Asanas) and meditation, for body-mental relaxation. The course will be led by expert yoga instructors for 2x60 to 90 min sessions, twice per week, within 2 to 4 weeks. The trainers will focus on promoting mindfulness, reducing anxiety, and improving focus to help participants manage daily performance stressors.

Intervention: Yoga (Behavioral)

Outcomes

Primary Outcomes

Trait Anxiety Reduction

Time Frame: 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.

The trait anxiety reduction will be measured with the Romanian validated version of the State-Trait Anxiety Inventory (STAI-Y2) Participant assessment: Previously trained and licensed STAI researchers will assess participants reported scores. The STAI-Y2 score ranges from 20 to 80, with higher scores indicating higher anxiety levels.

Secondary Outcomes

  • State Anxiety Reduction(Measured at baseline, before each session, and 30 minutes after the interventions.)
  • Emotional Regulation Strategies(Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.)
  • Quality of Life Improvement(Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.)

Investigators

Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marcel-Alexandru Gaina

Assistant Professor

Grigore T. Popa University of Medicine and Pharmacy

Study Sites (1)

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