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This study examines the effectiveness of virtual reality (VR) protocols based on mindfulness as a nonpharmacological approach to reduce social anxiety among adolescents. Conducted as a non-randomized, controlled, multi-center trial, the research aims to provide evidence supporting the integration of VR mindfulness interventions into clinical practice to improve mental health and well-being among adolescents. The research focuses on adolescent patients aged 12 to 18 who present with anxiety-related symptoms. Each participant will undergo a single primary care consultation, during which they will experience a 15-20 minute VR session using the Healthy Mind® platform both before and after their clinical encounter. Participants will be screened with the Generalized Anxiety Disorder 7 (GAD-7) scale. To measure changes in anxiety levels, the State-Trait Anxiety Inventory (STAI) will be administered immediately before and after the VR sessions. This setup aims to assess the immediate impact of immersive VR on perceived anxiety in a real-world outpatient environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Intervention | Experimental | Each participant will attend a single primary care clinic visit during which they will undergo the VR intervention. Before the VR session is conducted, participants will be screened using the Generalized Anxiety Disorder 7-item scale (GAD-7). If the GAD-7 score is more than 5, a 20-minute VR session will be administered before the consultation. Anxiety levels will be measured using State Trait Anxiety Inventory for Adolescents (STAI-A) [24] and the Visual Analog Scale (VAS) both before the initial VR session and after the consultation. This pre-post assessment will allow for the evaluation of immediate changes in social anxiety resulting from the VR experience within a real-world clinical setting |
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| Control | Other | Patients receiving standard of care. In the current clinical setting, adolescent patients attending primary care visits do not receive any structured mental health support or targeted anxiety-reduction strategies as part of routine care. Patients typically wait in the general clinic waiting area prior to their consultation, accompanied by their legal guardian. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Other | Participants will be instructed to engage in a virtual reality relaxation session lasting 20 minutes as part of their primary care visit. The intervention will use the Healthy Mind® virtual reality platform (developed in Paris, France) delivered through virtual reality headsets. Participants will be able to choose from a variety of immersive environments (e.g., beach, lake, mountain), each incorporating animated visuals, soothing audio, and guided breathing exercises. These VR scenarios are grounded in psychological relaxation principles such as cardiac coherence, hypnotic verbal accompaniment, and mindfulness-based stress reduction. |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory for Adolescents (STAI-A) Score | Minimum score: 20 (Least anxiety). Maximum score: 80 (Highest anxiety) | Baseline and immediately post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Minimum score: 0 (No anxiety), Maximum score: 10 (Highest anxiety) | Baseline and immediately post intervention |
| Generalized Anxiety Disorder - 7 Score | Minimum score: 0 (Minimal Anxiety), Maximum score: 21 (Severe anxiety) |
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Inclusion criteria:
Exclusion criteria:
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | Adolescent patients attending primary care visits do not receive any structured mental health support or targeted anxiety-reduction strategies as part of routine care prior to their appointments. |
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| Baseline and immediately post-intervention |