Evaluating Virtual Reality Use in Anxiety Management in Adolescents

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• State Trait Anxiety Inventory for Adolescents (STAI-A) Score [Срок оценки: Baseline and immediately post intervention]

Вторичные конечные точки (2)

• Visual Analog Scale (VAS) [Срок оценки: Baseline and immediately post intervention]
• Generalized Anxiety Disorder - 7 Score [Срок оценки: Baseline and immediately post-intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07681206 · IRB-2025-682

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗