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Not yet recruiting NCT07681206

Evaluating Virtual Reality Use in Anxiety Management in Adolescents

No phase Interventional Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality, Standard of care.
Who it may be relevant to
Registry conditions: Anxiety. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Virtual reality
    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 grou
  • Other Standard of care
    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 outcome measures

  • State Trait Anxiety Inventory for Adolescents (STAI-A) Score [Time frame: Baseline and immediately post intervention]
Secondary outcome measures (2)
  • Visual Analog Scale (VAS) [Time frame: Baseline and immediately post intervention]
  • Generalized Anxiety Disorder - 7 Score [Time frame: Baseline and immediately post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07681206 · IRB-2025-682

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗