Effectiveness of Virtual Reality Psychotherapy and Yoga on Student Performance Anxiety

NCT06639841 | Active Not Recruiting DMC

• 2 other identifiers: GAR56-IRB-466/24ICES 145/02.04.2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Performance Anxiety

Keywords

Performance anxiety; Students; Virtual Reality; Yoga; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Trait Anxiety Reduction

  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.

  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 (3)

• 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.

Other Outcomes (2)

• Performance Anxiety

  Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.

• Qualitative Intervention Feedback

  60 minutes before and after each intervention.

Study Arms (2)

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.

Device: Virtual Reality Psychotherapy

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.

Behavioral: Yoga

Interventions

Virtual Reality Psychotherapy DEVICE

Participants in this VR-facilited psychotherapy group will receive their treatment via Oculus Quest 2 and HTC Vive Flow wireless, standalone headsets systems to provide a comfortable immersive environment. The more hardware-intensive experiences will be carried out on Oculus Rift S headsets powered by high-end laptops. Sessions will last 30-60 minutes each, ranging from six to ten sessions within two to four weeks. The treatment will include reducing anxiety and improving emotion regulation through Cognitive-Behavioural techniques such as mindfulness, acceptance and commitement therapy, exposure therapy and 4-7-8 breathing. The same investigator will conduct all sessions to ensure uniformity. Additionally, subjects will undergo unsupervised VR at home with pre-programmed headsets to minimize investigator bias and maintain cosistancy of the relaxation and cognitive-behavioral strategies.

Also known as: VRG

Virtual Reality facilitated Psychotherapy for Performance Anxiety

Yoga BEHAVIORAL

The Yoga group members will be guided in a yoga class focused on managing performance anxiety. The interventions will consist of body exercises (Asanas), breath (Pranayama) and meditation to increase relaxation, consciousness and resilience; typical yoga postures like Surya Namaskar, Padahastasana, Virabhadrasana, Bhujangasana and Shavasana will be included in the session, as will breathing movements like Ujjayi (Victory Breath). Each class will be 60-90 minutes long, and 6-10 classes will be taught in two to four weeks. The technique will be progressive, from the basic to more advanced postures as participants cultivate confidence and resilience. All classes will conclude with meditation to ease tension and cultivate mindfulness.

Also known as: YG

Yoga Training for Performance Anxiety

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead
• Romanian Academy: collaborator
• Socola Institute of Psychiatry: collaborator

Study Sites (1)

Romanian Academy of Sciences

Iași, Iaşi, 700506, Romania

Location

Related Publications (1)

• Tofan CM, Magurianu LA, Axinte M, Gaina AM, Gaina M. Comparative Efficacy of Virtual Reality-Assisted Cognitive Behavioral Therapy Versus Yoga-Based Interventions for Reducing Performance Anxiety in Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 30;14:e66112. doi: 10.2196/66112.

  PMID: 40587850 DERIVED

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Marcel A Găină, Ass. Prof.

  University of Medicine and Pharmacy "Grigore T. Popa" Iași

  STUDY CHAIR

• Liviu A Măgurianu, Sci.Res.III

  Romanian Academy of Sciences "Gh. Zane" Institute Iasi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 15, 2024
• Primary Completion: March 8, 2025
• Study Completion: July 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be published starting 6 months after the study results are published and will be available 2 years from the publication.
• Access Criteria: Researchers who want to access the aforementioned data will need to make a formal request with a full scientific proposal outlining how the data will be used. The request will be reviewed by the external Data Safety and Monitoring Board (DSMB) review to verify that these requests are scientifically valid and ethical, in order to ensure participant data safety. The researchers who receive approval will have to sign a data-sharing contract regarding data protection within the specific utilization established terms.

Locations

RO (1)