Evaluating Virtual Reality Use in Anxiety Management in Adolescents

NCT07681206 | Not Yet Recruiting

• 1 other identifier: IRB-2025-682
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety

Keywords

Immersive virtual reality; Anxiety in adolescents

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline and immediately post intervention

Secondary Outcomes (2)

• Visual Analog Scale (VAS)

  Baseline and immediately post intervention

• Generalized Anxiety Disorder - 7 Score

  Baseline and immediately post-intervention

Study Arms (2)

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

Other: Virtual reality

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.

Other: Standard of care

Interventions

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.

Virtual Reality Intervention

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.

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal Investigator

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 2, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06