About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents aged 12-18 receiving care at the outpatient clinics of study locations
Patients with a GAD-7 score more than 5
Disqualifiers
Patients younger than 12 years old or older than 19 years old
Patients with a GAD-7 score lower than 5
Patient of legal age but subject to legal protection measures or unable to express their consent
Patients with dissociative psychiatric disorders
Trial design
Single group
Treatments tested in this trial
Virtual reality
Other interventionParticipants 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.
Standard of care
Other interventionAdolescent 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.
Treatment groups
Trial outcomes
Primary outcomes
State Trait Anxiety Inventory for Adolescents (STAI-A) Score
Minimum score: 20 (Least anxiety). Maximum score: 80 (Highest anxiety)
Secondary outcomes
Visual Analog Scale (VAS)
Minimum score: 0 (No anxiety), Maximum score: 10 (Highest anxiety)
Generalized Anxiety Disorder - 7 Score
Minimum score: 0 (Minimal Anxiety), Maximum score: 21 (Severe anxiety)
Locations
Sponsors and contacts
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