Virtual Reality for Children's Anxiety During MRI
Recruiting in Palo Alto (17 mi)
Overseen bySylvie Le May, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Justine's Hospital
Disqualifiers: Epilepsy, Cannot sit upright, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
12678How 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.
12389Eligibility 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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality DistractionExperimental Treatment1 Intervention
Use of Virtual Reality (VR) before the MRI.
Group II: Standard TreatmentActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maisonneuve-Rosemont HospitalMontréal, Canada
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Who Is Running the Clinical Trial?
St. Justine's HospitalLead Sponsor
Maisonneuve-Rosemont HospitalCollaborator
References
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]A magnetic resonance imaging (MRI) procedure can cause preprocedural and periprocedural anxiety in children. Psychosocial interventions are used to prepare children for the procedure to alleviate anxiety, but these interventions are time-consuming and costly, limiting their clinical use. Virtual reality (VR) is a promising way to overcome these limitations in the preparation of children before an MRI scan.
The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. [2022]It is known that magnetic resonance imaging (MRI) procedures generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI procedure to be repeated with sedation. Few studies seem to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for MRI scans and how to identify which children are more responsive.
Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. [2023]Exposure-based cognitive behavior therapy (CBT) has demonstrated efficacy and is recommended as a front-line treatment for childhood anxiety. Unfortunately, challenges exist that impact the effective implementation of exposure-based CBT in clinical practice. One of the primary challenges is the accessibility and availability of exposure stimuli (e.g., spiders, storms, heights) in CBT sessions. Immersive virtual reality (VR) has shown promise as a scalable and sustainable solution to address this clinical need, but remains largely untested in youth with anxiety disorders. Here, we examine the use of VR exposures in the treatment of youth with an anxiety disorder (i.e., specific phobias). We aimed to investigate: (1) the feasibility and clinical benefit of VR exposures; (2) whether VR exposures elicit changes in physiological arousal and/or subjective distress; and (3) whether habituation serves as a mechanism across physiological and subjective outcomes for VR exposures. Three youth and their parents completed a clinical evaluation, which was followed by a one session treatment (OST) with VR exposures. Afterward, youth and parents completed clinical assessments one-week and 1-month after treatment. Immersive VR exposures were found to be feasible and demonstrated clinical benefit for reducing anxiety severity. Additionally, VR exposures elicited changes in both physiological and subjective outcomes. Finally, physiological habituation to VR exposures was observed among participants who exhibited treatment response at follow-up. Collectively, these findings demonstrate preliminary evidence that VR exposures are feasible, tolerable, and show some therapeutic benefit for treating youth with anxiety.
Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. [2011]Virtual reality (VR) has been demonstrated as an effective tool to help people overcome a variety of anxiety disorders. In this case study, the use of VR as a distractor to alleviate pain and anxiety associated with an invasive medical procedure for a pediatric cancer patient was explored. An A-B-C-A design during four consecutive medical appointments in an outpatient oncology clinic compared no distraction (A), non-VR distraction on a computer screen (B), and VR distraction with a head set (C). Behavioral observations of distress by the researcher and reports of pain and anxiety by the patient, parent, and nurse were taken before and during the procedure. The child's pulse was monitored throughout the procedure. The findings from this case study suggest benefit from using VR distraction, as indicated by lower pain and anxiety ratings, reduced pulse, and fewer observed behavioral indices of distress. The need for larger scale studies and application of VR with younger children is discussed in the context of confirming effectiveness of this technique and providing more generalizable information about efficacy.
Virtual Reality vs. Tablet Video as an Experiential Education Platform for Pediatric Patients Undergoing Chest Radiography: A Randomized Clinical Trial. [2021]Virtual reality (VR), which offers an immersive experience, has been implemented into the education of pediatric patients to reduce peri-procedural anxiety. This randomized clinical trial evaluated the effect of VR, compared with standard video, on reducing anxiety and distress in pediatric patients undergoing chest radiography. A total of 120 children aged 4 to 8 years with scheduled chest radiography appointments were randomized into either the tablet or the VR group. Children in the tablet group experienced chest radiography indirectly with a 3 min tablet video, whereas those in the VR group received the same content via a VR experience. The distress of children was measured using the Observational Scale of Behavioral Distress (OSBD) scale. Parental presence and procedural outcomes were also recorded. The number of less distressed children (OSBD score < 5) was significantly higher in the VR group than in the tablet group (49 [81.7%]) vs. 32 [53.3%]) (p = 0.001). The OSBD scores, the need for parental presence, the procedure time, and the number of repeated procedures were all lower in the VR group. The immersive VR experience appears to decrease the degree of anxiety in children and increase the efficiency of the procedures compared with the tablet video with the same content.
Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]The impact of virtual reality on access to exposure therapy and recovery from anxiety is unrealized, but an argument can be made that this is about to change. Virtual reality exposure therapy for anxiety disorders is safe, effective, and, in most cases, as effective as in vivo exposure therapy. Clinician attitudes toward virtual reality are now more positive than negative. Moderately priced virtual reality systems are commercially available. Self-guided and fully automated programs for specific fears are new, scalable, potentially game-changing developments. Future research that assesses cultural bias and external validity will position virtual reality exposure therapy to address mental health disparities, to realize its potential to increase access to effective treatment for anxiety disorders, and to improve public health.
Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. [2022]Virtual reality (VR) is an emerging tool for anxiety and fear reduction in pediatric patients. VR use is facilitated by Certified Child Life Specialists (CCLS) at pediatric hospitals. The primary aim of this study was to retrospectively review the safety of VR by analyzing adverse events after the utilization of VR under CCLS supervision. Secondary objectives were to characterize the efficacy of VR in enhancing patient cooperation, describe the integration of VR into Child Life services, and identify interventions that accompanied VR.
Virtual reality exposure therapy. [2012]It has been proposed that virtual reality (VR) exposure may be an alternative to standard in vivo exposure. Virtual reality integrates real-time computer graphics, body tracking devices, visual displays, and other sensory input devices to immerse a participant in a computer-generated virtual environment. Virtual reality exposure is potentially an efficient and cost-effective treatment of anxiety disorders. VR exposure therapy reduced the fear of heights in the first controlled study of virtual reality in treatment of a psychiatric disorder. A case study supported the efficacy of VR exposure therapy for the fear of flying. The potential for virtual reality exposure treatment for these and other disorders is explored, and therapeutic issues surrounding the delivery of VR exposure are discussed.
[What do virtual reality tools bring to child and adolescent psychiatry?] [2022]Virtual reality is a relatively new technology that enables individuals to immerse themselves in a virtual world. It offers several advantages including a more realistic, lifelike environment that may allow subjects to "forget" they are being assessed, allow a better participation and an increased generalization of learning. Moreover, the virtual reality system can provide multimodal stimuli, such as visual and auditory stimuli, and can also be used to evaluate the patient's multimodal integration and to aid rehabilitation of cognitive abilities. The use of virtual reality to treat various psychiatric disorders in adults (phobic anxiety disorders, post-traumatic stress disorder, eating disorders, addictions…) and its efficacy is supported by numerous studies. Similar research for children and adolescents is lagging behind. This may be particularly beneficial to children who often show great interest and considerable success on computer, console or videogame tasks. This article will expose the main studies that have used virtual reality with children and adolescents suffering from psychiatric disorders. The use of virtual reality to treat anxiety disorders in adults is gaining popularity and its efficacy is supported by various studies. Most of the studies attest to the significant efficacy of the virtual reality exposure therapy (or in virtuo exposure). In children, studies have covered arachnophobia social anxiety and school refusal phobia. Despite the limited number of studies, results are very encouraging for treatment in anxiety disorders. Several studies have reported the clinical use of virtual reality technology for children and adolescents with autistic spectrum disorders (ASD). Extensive research has proven the efficiency of technologies as support tools for therapy. Researches are found to be focused on communication and on learning and social imitation skills. Virtual reality is also well accepted by subjects with ASD. The virtual environment offers the opportunity to administer controlled tasks such as the typical neuropsychological tools, but in an environment much more like a standard classroom. The virtual reality classroom offers several advantages compared to classical tools such as more realistic and lifelike environment but also records various measures in standardized conditions. Most of the studies using a virtual classroom have found that children with Attention Deficit/Hyperactivity Disorder make significantly fewer correct hits and more commission errors compared with controls. The virtual classroom has proven to be a good clinical tool for evaluation of attention in ADHD. For eating disorders, cognitive behavioural therapy (CBT) program enhanced by a body image specific component using virtual reality techniques was shown to be more efficient than cognitive behavioural therapy alone. The body image-specific component using virtual reality techniques boots efficiency and accelerates the CBT change process for eating disorders. Virtual reality is a relatively new technology and its application in child and adolescent psychiatry is recent. However, this technique is still in its infancy and much work is needed including controlled trials before it can be introduced in routine clinical use. Virtual reality interventions should also investigate how newly acquired skills are transferred to the real world. At present virtual reality can be considered a useful tool in evaluation and treatment for child and adolescent disorders.