Virtual Reality for Anxiety

Recruiting at 1 trial location

Overseen By Sylvie Le May, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Epilepsy, Cannot sit upright, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality games can reduce anxiety in children about to undergo an MRI scan. The goal is to determine if playing these games before the scan makes the experience less stressful compared to usual care. Children aged 7 to 17 who need an MRI and can sit upright may qualify, provided they do not have epilepsy or similar conditions. Participants will either try the virtual reality game or follow the standard procedure. The trial seeks to offer a new, drug-free method to help children feel calmer during MRIs. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could transform MRI experiences for children.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that this virtual reality method is safe for children?

Research has shown that virtual reality (VR) therapy is generally safe and well-tolerated for treating anxiety. Studies have found that VR therapy effectively lowers anxiety levels, with most people experiencing only minor side effects. One review found VR helpful for anxiety issues like social anxiety and fear of public speaking, without causing major side effects. Another study noted that VR safely helps manage stress and anxiety, with only minor side effects reported. These findings suggest that VR is a promising and safe tool for managing anxiety, especially during procedures like MRI scans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for anxiety because it offers a unique and immersive way to help patients relax. Unlike traditional treatments that might involve medication or talk therapy, VR provides a high-tech distraction that can be especially useful before stress-inducing situations like an MRI. This approach is non-invasive and can be tailored to individual needs, making it a flexible option. The potential of VR to quickly calm anxiety without side effects is what makes it particularly promising.

What evidence suggests that this virtual reality method is effective for managing anxiety during MRIs?

Research has shown that virtual reality (VR) therapy can effectively reduce anxiety. Studies have found that VR therapy works as well as traditional methods for treating specific fears and anxiety disorders. Reviews of multiple studies highlight that VR can greatly improve anxiety levels in patients. In this trial, one group will use VR as a distraction before an MRI, potentially helping children feel calmer and less scared. This drug-free approach could serve as a useful tool for managing anxiety during medical procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 7 to 17 who need an MRI and have a parent or guardian who can consent in French or English. It's designed to see if playing a virtual reality game before the scan helps with anxiety.

Inclusion Criteria

My parent or guardian who speaks English or French will accompany me and can consent.

Required to undergo MRI

I am between 7 and 17 years old.

Exclusion Criteria

I can sit in a semi-upright position for the VR session.

I cannot play virtual reality games due to epilepsy or another condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Field Test Phase

A field test phase with 10 participants to address the feasibility and acceptability of the VR intervention

Not specified

1 visit (in-person)

Randomized Controlled Trial (RCT)

Participants are divided into two groups: experimental group receiving pre-procedural IVR game preparation and usual care group receiving standard care

Not specified

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study tests whether a pre-procedural immersive VR game can reduce anxiety during MRIs compared to standard care. Participants will be randomly assigned to either the VR group or usual care, with equal numbers in each group.

How Is the Trial Designed?

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

Use of Virtual Reality (VR) before the MRI.

Group II: Standard Treatment Active Control 1 Intervention

Standard Treatment used at the radiology department.

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Published Research Related to This Trial

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an effective standalone treatment.

Combining VRBET with cognitive therapy did not result in significant improvements over VRBET alone, suggesting that VRBET may be sufficient for addressing agoraphobia without the need for additional cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. Malbos, E., Rapee, RM., Kavakli, M.[2011]

Virtual reality (VR) exposure therapy has been shown to be effective for treating anxiety disorders, with a growing focus on complex conditions like social anxiety disorder, beyond just specific phobias.

The advancement of VR technology has established it as both a therapeutic tool and a research method, highlighting the need for further studies on its efficacy in treating various anxiety disorders and understanding the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of virtual reality as an exposure technique]. Diemer, J., Zwanzger, P.[2020]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

Virtual reality (VR) is an effective and immersive tool for treating psychiatric disorders, particularly anxiety, by providing controlled sensory stimulation in a three-dimensional environment.

The review highlights the empirical evidence supporting VR-based interventions and suggests that VR can be a convenient and cost-effective addition to traditional psychiatric treatments, with recommendations for its integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Maples-Keller, JL., Bunnell, BE., Kim, SJ., et al.[2022]

A review of 27 randomized controlled trials (RCTs) on virtual reality exposure therapy (VRET) for anxiety disorders found that the overall quality of the studies was low, with an average adherence to only 2.85 out of 8 research design criteria.

While VRET appears to be an effective treatment option, the variability in study quality and the reduction in effect size for larger sample sizes suggest that caution is needed when interpreting the results and comparing VRET to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. McCann, RA., Armstrong, CM., Skopp, NA., et al.[2022]

A systematic review of 17 studies involving 827 participants found that virtual reality (VR) applications can significantly reduce anxiety symptoms compared to passive control groups, with a strong effect size of 1.29.

While VR applications showed a non-significant overall effect compared to conventional therapies, they provide a valuable treatment option, especially when traditional therapies are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of virtual reality applications in the treatment of anxiety disorders: A systematic review and meta-analysis of randomized-controlled trials. Schröder, D., Wrona, KJ., Müller, F., et al.[2023]

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]

The SoREAL-trial is a clinical study involving 302 patients with social anxiety disorder and/or agoraphobia, comparing traditional in-person cognitive behavioral therapy (CBT-in vivo) to virtual reality-based exposure therapy (CBT-in virtuo) over a 14-week treatment period.

The primary outcomes will assess specific anxiety symptoms using validated scales, with the trial aiming to provide insights into the efficacy and patient satisfaction of virtual reality exposure as a potentially less aversive alternative to traditional exposure therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial. Arnfred, B., Bang, P., Hjorthøj, C., et al.[2022]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Virtual reality therapy is proposed as an effective alternative to traditional exposure methods in cognitive behavioral therapy for anxiety disorders, showing at least equivalent efficacy to in vivo exposure for conditions like specific phobias and PTSD.

The immersive nature of virtual reality creates a strong sense of 'presence,' enhancing the therapeutic experience and suggesting that it may function as an embodied therapy rather than just a method of exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in the care management of anxiety disorders]. Levy, F., Rautureau, G., Jouvent, R.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904249/

Effectiveness of virtual reality therapy in the treatment ... The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10592498/

Virtual reality (VR) treatments for anxiety disorders are ... Meta-analyses have shown that VR-assisted exposure therapy (VRET) is as effective as in vivo exposures for specific phobias and has large effects versus ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1386505625001194

Review article Self-guided virtual reality therapy for anxiety The findings revealed that self-guided VR interventions for anxiety can provide an effective treatment of social anxiety disorder, public speaking anxiety, and ...

4. link.springer.com link.springer.com/article/10.1007/s10055-025-01181-6

Exploring the potential of virtual reality (VR) in mental ... (2022) conducted a meta-analysis that demonstrated the efficacy of VR exposure-based cognitive behavioural therapy (CBT) for severe anxiety ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589979125000046

Examining the comparative effectiveness of virtual reality ... Conclusions. Results of the meta-analysis demonstrate that VRET generates positive outcomes in the treatment of Specific Phobia and Social Anxiety Disorders ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125001510

The impact of virtual reality interventions on stress and ... The minimal side effects reported suggest that VR can be a safe adjunct therapy for alleviating anxiety and pain, common issues in ICU settings. ... Hypnosis ...

7. careersinpsychology.org careersinpsychology.org/why-virtual-reality-transform-mental-health-treatment/

VR Therapy Careers: Virtual Reality Mental Health 2025 Research shows 60–90% success rates for VR-based exposure therapy for specific phobias, though results vary by condition and patient. To work in ...