Virtual Reality As Anxiety Management Tool for Preparing Children for MR Exam (LIVE)

EvaLuation De L'apport De L'Irm Virtuelle Sur La Qualité De La Prise En Charge Des Enfants En Irm

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.

Study Overview

• Status: Completed
• Conditions: Claustrophobia
• Intervention / Treatment: Device: Virtual Reality headset

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54500
    • CHRU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child from 6 to 12 years old,
• Child who will have an MRI for the first time,
• Outpatient child,
• Child dependent on a parent affiliated to or beneficiary of a social security scheme,
• Child who has received age-appropriate information on the organization of the research,
• Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.

Exclusion Criteria:

• Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
• Child with a contraindication to performing an MRI,
• Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
• Child's opposition to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI simulation; MRI simulation with a Virtual Reality headset	Device: Virtual Reality headset; MRI simulation with a Virtual Reality headset
No Intervention: Standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10	2 hours

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Coralie SERVAIT, PI, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: 2019-A03072-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No