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NCT Number: NCT07681206

Evaluating Virtual Reality Use in Anxiety Management in Adolescents

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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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescents aged 12-18 receiving care at the outpatient clinics of study locations
  • Patients with a GAD-7 score more than 5

Exclusion criteria

  • 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
  • Patients suffering from uncontrolled epilepsy
  • Patients with visual or auditory disorders
  • Patients suffering from claustrophobia or motion sickness
  • Patients with face infections

Treatment and study plan

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.

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.

Primary outcomes

  1. State Trait Anxiety Inventory for Adolescents (STAI-A) Score

    Time frame: Baseline and immediately post intervention

    Minimum score: 20 (Least anxiety). Maximum score: 80 (Highest anxiety)

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Baseline and immediately post intervention

    Minimum score: 0 (No anxiety), Maximum score: 10 (Highest anxiety)

  2. Generalized Anxiety Disorder - 7 Score

    Time frame: Baseline and immediately post-intervention

    Minimum score: 0 (Minimal Anxiety), Maximum score: 21 (Severe anxiety)

Sponsors and collaborators

Lead sponsor

Mohammed Bin Rashid University of Medicine and Health Sciences

Other

Registry information

Official study title

Evaluating the Potential of Virtual Reality Intervention in Anxiety Management Among Adolescent Patients: An Interventional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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