Virtual Reality for Children's Anxiety During MRI

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

98 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of virtual reality (VR) on anxiety in children scheduled for an MRI and how to identify which children are more responsive. Objective: The aims of this study are three-fold: 1- to develop an algorithm of predictability based on biofeedback; 2- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CIUSSS de l'Est de l'Île de Montréal, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics and measures of procedure related-anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature and muscle tension. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Conclusions: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.

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 data supports the effectiveness of the treatment Virtual Reality for reducing anxiety in children during MRI procedures?

Research shows that virtual reality (VR) can help reduce anxiety in children during medical procedures. For example, a study found that VR reduced anxiety and distress in children undergoing chest radiography, and another study showed that VR exposures were beneficial for treating childhood anxiety. These findings suggest VR could be effective in reducing anxiety during MRI scans as well. ^{1 2 3 4 5}

Is virtual reality therapy safe for children?

Research shows that virtual reality (VR) therapy is generally safe for children, with no significant adverse events reported when used under supervision in pediatric hospitals. It has been used effectively to reduce anxiety and fear in various settings. ^{1 2 6 7 8}

How does virtual reality treatment differ from other treatments for children's anxiety during MRI?

Virtual reality treatment is unique because it immerses children in a lifelike virtual environment, which can help them feel more comfortable and less anxious during an MRI. Unlike traditional methods, VR can provide a more engaging and interactive experience, potentially reducing the need for sedation and making the process more efficient and cost-effective. ^{1 2 3 8 9}

Research Team

Sylvie Le May, PhD

Principal Investigator

Research Centre CHU Sainte-Justine

Christine Genest, PhD

Principal Investigator

Research Centre IUSMM

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. Canada 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. [2023]

2. Canada 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. [2011]

5. Switzerland 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. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy. [2012]

9. France pubmed.ncbi.nlm.nih.gov

[What do virtual reality tools bring to child and adolescent psychiatry?] [2022]