Performance AnxietyVRvsHYNCT06639841
Effectiveness of Virtual Reality Psychotherapy and Yoga on Student Performance Anxiety
A study testing Virtual Reality Psychotherapy and Yoga in people with Performance Anxiety, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Anxiety
- What is being tested?
- Virtual Reality Psychotherapy and Yoga
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteRomania
- Study dates
- 15 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Effectiveness of Virtual Reality-Facilitated Psychotherapy vs. Yoga-Based Interventions for Managing Performance Anxiety Among Students
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.
Read more
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.
Read the 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.
- Conditions
- Performance Anxiety
- Being tested
- Virtual Reality Psychotherapy, Yoga
- Keywords
- Performance anxiety, Students, Virtual Reality, Yoga, Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality PsychotherapyDevice
Also called VRG
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.
YogaBehavioural
Also called YG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
We will assess state anxiety using the Romanian validated version of the State-Trait Anxiety Inventory (STAI-Y1); scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: Measured at baseline, before each session, and 30 minutes after the interventions.
Emotional Regulation Strategies
Emotional regulation strategies will be measured by the Emotion Regulation Questionnaire (ERQ), which measures two basic processes in emotional regulation: cognitive reappraisal and expressive suppression.
Measured: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
Quality of Life Improvement
The quality of life will be measured through the Romanian population validated Quality of Life Inventory (QoLI) to reflect the participants' wellbeing and the impact of academic stress and anxiety. The scores will be assessed by a previously QoLi trained and licenced investigator.
Measured: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Sep 2024
- Primary completion15 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Performance AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Romanian Academy, Socola Institute of Psychiatry
- Responsible party
- Principal investigator, Marcel-Alexandru Gaina, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Marcel A Găină, Ass. Prof., Study chair, University of Medicine and Pharmacy "Grigore T. Popa" IașiLiviu A Măgurianu, Sci.Res.III, Study director, Romanian Academy of Sciences "Gh. Zane" Institute Iasi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639841
- Sponsor's protocol ID
- GAR56-IRB-466/24
- Other IDs
- ICES 145/02.04.2024
- Acronym
- VRvsHY
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD to be shared will consist of all anonymized information from the primary and secondary outcome measures, baseline information, and any other supporting data such as participant demographics. The data dictionaries, as well as any datasets supporting the published results will be distributed. These data will be available for future analysis, verification of the study results, or replication by other researchers. Time Frame: Access Criteria:
Publications
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.
PubMed 40587850
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Effectiveness of Virtual Reality-Facilitated Psychotherapy vs. Yoga-Based Interventions for Managing Performance Anxiety Among Students
- ClinicalTrials.gov ID
- NCT06639841
- Acronym / sponsor ID
- VRvsHY / GAR56-IRB-466/24
- Conditions
- Performance Anxiety
- Keywords
- Performance anxiety, Students, Virtual Reality, Yoga, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Romanian Academy, Socola Institute of Psychiatry
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality facilitated Psychotherapy for Performance Anxiety | Experimental | Device: Virtual Reality PsychotherapyParticipants 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. |
| Yoga Training for Performance Anxiety | Experimental | Behavioral: YogaParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality PsychotherapyAlso: VRGParticipants 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. | Device | Virtual Reality facilitated Psychotherapy for Performance Anxiety |
| YogaAlso: YGThe 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. | Behavioural | Yoga Training for Performance Anxiety |
Primary outcome
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.
3 secondary outcomes
State Anxiety Reduction
Time frame: Measured at baseline, before each session, and 30 minutes after the interventions.
Emotional Regulation Strategies
Time frame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
Quality of Life Improvement
Time frame: Measured 1 day before the first intervention session and within 1 day after the final intervention session of the program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 40587850Tofan 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.
- Individual participant dataSharing planned: Yes. The IPD to be shared will consist of all anonymized information from the primary and secondary outcome measures, baseline information, and any other supporting data such as participant demographics. The data dictionaries, as well as any datasets supporting the published results will be distributed. These data will be available for future analysis, verification of the study results, or replication by other researchers. Time Frame: Access Criteria:
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel A Găină, Ass. Prof. study chair
University of Medicine and Pharmacy "Grigore T. Popa" Iași
Liviu A Măgurianu, Sci.Res.III study director
Romanian Academy of Sciences "Gh. Zane" Institute Iasi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Psychotherapy and Yoga in people with Performance Anxiety, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.