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      The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial


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          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.


          The aims of this study are 3-fold: develop an algorithm of predictability based on biofeedback, address feasibility and acceptability of preprocedural IVR game preparation for anxiety management during MRI procedures, and examine the efficacy of IVR game preparation compared with usual care for the management of procedural anxiety during MRI scans.


          This study will have 2 phases. We will first conduct a field test with 10 participants aged 7 to 17 years to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. After the field test, a randomized controlled trial will be completed using a parallel design with 2 groups: an experimental group (preprocedural IVR game preparation) and a usual care group (standard care as per the radiology department’s protocol) in an equal ratio of 49 participants per group for 98 participants. Recruitment will be carried out at a hospital in Quebec, Canada. The experimental group will receive a preprocedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI scan. 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 sociodemographic and clinical characteristics as well as measures of procedure-related anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (score 1-3) and the Children’s Fear Scale (score 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature, and muscle tension. Measures of the level of satisfaction of health care professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a Cronbach α significance level of .05.


          As of May 10, 2022, no participant was enrolled in the clinical trial. The data collection time frame is projected to be between April 1, 2022, and March 31, 2023. Findings will be disseminated through peer-reviewed publications.


          Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI procedure. 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 nonpharmacological therapeutic modality for anxiety management in children scheduled for an MRI scan.

          Trial Registration

          ClinicalTrials.gov NCT04988516; https://clinicaltrials.gov/ct2/show/NCT04988516

          International Registered Report Identifier (IRRID)


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          Most cited references44

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          A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns.

          This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6-19 years old) performed range-of-motion exercises under a therapist's direction for 1-5 days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects' perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27-44%) in pain ratings during virtual reality. They also reported improved affect ("fun") during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. Copyright © 2010 Elsevier Ltd and ISBI. All rights reserved.
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            Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations.

            Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.
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              Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management

              To conduct a randomized control trial to evaluate the feasibility and efficacy of virtual reality (VR) compared with standard of care (SOC) for reducing pain, anxiety, and improving satisfaction associated with blood draw in children ages 10-21 years.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                June 2022
                13 June 2022
                : 11
                : 6
                : e30616
                [1 ] Research Center Centre Hospitalier Universitaire Sainte-Justine Montreal, QC Canada
                [2 ] Faculty of Nursing Université de Montréal Montreal, QC Canada
                [3 ] Trauma Studies Centre Institut Universitaire en Santé Mentale de Montréal Centre Intégré Universitaire de Santé et de Services Sociaux de l’Est-de-l’Île de Montréal Montreal, QC Canada
                [4 ] Faculty of Medicine Université de Montréal Montreal, QC Canada
                [5 ] Université du Québec en Abitibi-Témiscamingue Rouyn-Noranda, QC Canada
                [6 ] School of Criminology Université de Montréal Montreal, QC Canada
                Author notes
                Corresponding Author: Sylvie Le May sylvie.lemay@ 123456umontreal.ca
                Author information
                ©Sylvie Le May, Christine Genest, Nicole Hung, Maxime Francoeur, Estelle Guingo, Julie Paquette, Olivier Fortin, Stéphane Guay. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.06.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 1 September 2021
                : 11 January 2022
                : 6 March 2022
                : 11 May 2022

                virtual reality,children,video games,magnetic resonance imaging,anxiety,pediatrics,patient collaboration,patient preparation,biofeedback


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