AnxietyNCT07681206
Evaluating Virtual Reality Use in Anxiety Management in Adolescents
A study testing Virtual reality in people with Anxiety, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 12-18 receiving care at the outpatient clinics of study locations
- Patients with a GAD-7 score more than 5
Who cannot join
- 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
About this study
Official title: Evaluating the Potential of Virtual Reality Intervention in Anxiety Management Among Adolescent Patients: An Interventional Study
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
- Being tested
- Virtual reality, Standard of care
- Keywords
- Immersive virtual reality, Anxiety in adolescents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory for Adolescents (STAI-A) Score
Minimum score: 20 (Least anxiety). Maximum score: 80 (Highest anxiety)
Measured: Baseline and immediately post intervention
Secondary outcomes (2)
Visual Analog Scale (VAS)
Minimum score: 0 (No anxiety), Maximum score: 10 (Highest anxiety)
Measured: Baseline and immediately post intervention
Generalized Anxiety Disorder - 7 Score
Minimum score: 0 (Minimal Anxiety), Maximum score: 21 (Severe anxiety)
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start23 Jun 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Alabdullah, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681206
- Sponsor's protocol ID
- IRB-2025-682
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Potential of Virtual Reality Intervention in Anxiety Management Among Adolescent Patients: An Interventional Study
- ClinicalTrials.gov ID
- NCT07681206
- Acronym / sponsor ID
- IRB-2025-682
- Conditions
- Anxiety
- Keywords
- Immersive virtual reality, Anxiety in adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 23 Jun 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention | Experimental | Other: Virtual realityEach 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 |
| Control | Other | Other: Standard of carePatients 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents aged 12-18 receiving care at the outpatient clinics of study locations
- Patients with a GAD-7 score more than 5
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityParticipants 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. | Other | Virtual Reality Intervention |
| Standard of careAdolescent 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. | Other | Control |
Primary outcome
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)
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline and immediately post intervention
Generalized Anxiety Disorder - 7 Score
Time frame: Baseline and immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Anxiety, run by Mohammed Bin Rashid University of Medicine and Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory for Adolescents (STAI-A) Score (time frame: Baseline and immediately post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.