An interventional study of Virtual Reality headset in Claustrophobia, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.
The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Contraindication
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MRI simulation with a Virtual Reality headset
Device: Virtual Reality headset
Standard medical care
MRI simulation with a Virtual Reality headset
Anxiety
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
Time frame: 2 hours
Ran from Nov 2020 to primary completion in Oct 2023, 35 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Claustrophobia
Central Hospital, Nancy, France →