Virtual Reality for Children's Anxiety During MRI

Not currently 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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality (VR) can reduce anxiety in children undergoing an MRI. By introducing a VR game before the procedure, the study will compare its effects to the standard care provided by the radiology department. The researchers aim to identify which children respond best to this approach through biofeedback, such as heart rate. Children aged 7 to 17 who need an MRI and can use VR may qualify, especially if they experience anxiety about medical procedures. As an unphased trial, this study offers a unique opportunity for children to potentially reduce their anxiety and improve their MRI experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using virtual reality to manage anxiety during MRIs, so it's best to consult with the trial coordinators for specific guidance.

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

Research has shown that virtual reality (VR) can safely reduce anxiety in children during medical procedures. For example, one study found that VR reduced anxiety and distress in children undergoing chest X-rays. Another study demonstrated that VR significantly lowered anxiety levels in children scheduled for an MRI scan.

Reports indicate that children generally handle VR well, experiencing few side effects, making it easy for them to use. While the current trial focuses on anxiety during MRI scans, these findings suggest VR could serve as a non-drug option to manage anxiety in young patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality (VR) to help ease children's anxiety during MRIs because it offers a unique, immersive distraction that traditional methods lack. Unlike standard treatments in radiology, which often involve verbal reassurance or sedation, VR engages children visually and mentally by transporting them to a virtual world, potentially reducing their stress and fear. This innovative approach not only aims to make the MRI experience more comfortable for young patients but also hopes to decrease the need for sedation, making the process safer and more efficient.

What evidence suggests that virtual reality is effective for managing children's anxiety during MRI?

Research shows that virtual reality (VR) can help reduce anxiety in children, especially during hospital procedures like MRIs. In this trial, some participants will receive VR therapy before their MRI. Studies have found that VR offers a safe and fun way for kids to experience a pretend version of the MRI, which can help them feel more at ease. In some cases, VR successfully lowered anxiety levels and even reduced the need for sedation. Early results suggest that when children use VR before an MRI, they often feel less nervous. This method provides a playful and drug-free way to help manage anxiety for young patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Sylvie Le May, PhD

Principal Investigator

Research Centre CHU Sainte-Justine

Christine Genest, PhD

Principal Investigator

Research Centre IUSMM

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 not suitable for those outside this age range or without parental consent.

Inclusion Criteria

My parent or guardian who speaks English or French has agreed to help me with this trial.

Required to undergo MRI

I am between 7 and 17 years old.

Exclusion Criteria

I can sit in a semi-upright position as required for VR gear.

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

Initial phase with 10 participants to develop a predictive algorithm for biofeedback and assess feasibility and acceptability of the VR intervention.

4 weeks

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.

8 weeks

Multiple visits (in-person) for MRI and assessments

Follow-up

Participants are monitored for safety and effectiveness after the intervention and MRI procedure.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The study tests if playing a VR game before an MRI can help manage anxiety compared to standard care. Participants will be randomly placed into two groups: one with the VR game prep and one with usual care, to see which works better.

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+

Maisonneuve-Rosemont Hospital

Collaborator

Trials

102

Recruited

38,300+

Published Research Related to This Trial

A study involving 3,696 pediatric patients showed that virtual reality (VR) is safe for use, with very few adverse events reported, such as increased anxiety in 3.8% of cases and dizziness or nausea in less than 1%.

The use of VR significantly improved patient cooperation during medical procedures, with 99.5% of patients being cooperative after VR intervention compared to 96.7% before, indicating its efficacy in enhancing the patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. Caruso, TJ., O'Connell, C., Qian, JJ., et al.[2022]

Immersive virtual reality (VR) exposures are feasible and show clinical benefits in reducing anxiety severity in youth with specific phobias, based on a study involving three youth and their parents who underwent a one-session treatment.

The use of VR exposures resulted in significant changes in both physiological arousal and subjective distress, with evidence of physiological habituation observed in participants who responded positively to the treatment at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. Ramsey, KA., Essoe, JK., Boyle, N., et al.[2023]

Virtual reality (VR) exposure therapy has shown promise as an effective and cost-efficient alternative to traditional exposure therapy for treating anxiety disorders, particularly in reducing fear of heights and fear of flying.

The initial controlled studies indicate that VR can successfully immerse participants in a virtual environment, which may enhance therapeutic outcomes for various anxiety-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy. Rothbaum, BO., Hodges, L., Kooper, R.[2012]

In a case study involving a pediatric cancer patient, virtual reality (VR) was found to significantly reduce pain and anxiety during invasive medical procedures, as evidenced by lower pain ratings, reduced pulse, and fewer behavioral signs of distress.

The study compared VR distraction to non-VR methods and no distraction across four medical appointments, highlighting the potential of VR as an effective tool for managing anxiety in children undergoing medical treatments, though larger studies are needed for broader validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Gershon, J., Zimand, E., Lemos, R., et al.[2011]

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]

A virtual reality (VR) smartphone app was developed to help prepare children aged 6 to 14 for MRI procedures, aiming to reduce their anxiety before and during the scan.

In a randomized controlled trial with 128 participants, the VR intervention is expected to significantly lower anxiety levels compared to standard care, allowing children to familiarize themselves with the MRI environment in a comfortable home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Smartphone Virtual Reality Exposure Preparation to Care as Usual in Children Aged 6 to 14 Years Undergoing Magnetic Resonance Imaging: Protocol for a Multicenter, Observer-Blinded, Randomized Controlled Trial. van Spaendonck, Z., Leeuwenburgh, KP., Dremmen, M., et al.[2023]

The study aims to evaluate the effectiveness of immersive virtual reality (IVR) game preparation in reducing anxiety for children undergoing MRI scans, with a randomized controlled trial involving 98 participants planned to compare IVR with standard care.

The research will also develop a predictive algorithm using biofeedback to identify which children may benefit most from the IVR intervention, potentially offering a nonpharmacological approach to managing anxiety in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. Le May, S., Genest, C., Hung, N., et al.[2022]

Virtual reality (VR) has shown significant efficacy in treating anxiety disorders in children and adolescents, with studies indicating positive outcomes for conditions like arachnophobia and social anxiety, despite the limited number of studies available.

VR technology is also beneficial for children with autism spectrum disorders (ASD) and Attention Deficit/Hyperactivity Disorder (ADHD), providing a realistic environment for therapy and evaluation, and enhancing cognitive behavioral therapy for eating disorders by improving body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What do virtual reality tools bring to child and adolescent psychiatry?] Bioulac, S., de Sevin, E., Sagaspe, P., et al.[2022]

In a study of 120 children aged 4 to 8 undergoing chest radiography, those using virtual reality (VR) experienced significantly less anxiety, with 81.7% showing low distress compared to 53.3% in the standard video group.

The VR group not only had lower anxiety scores but also required less parental presence and had shorter procedure times, indicating that VR can enhance the efficiency of medical procedures for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality vs. Tablet Video as an Experiential Education Platform for Pediatric Patients Undergoing Chest Radiography: A Randomized Clinical Trial. Ryu, JH., Park, JW., Choi, SI., et al.[2021]

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Virtual Reality for Children's Anxiety During MRI

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