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
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2023
CompletedJanuary 30, 2025
February 1, 2024
3 years
August 5, 2020
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
2 hours
Study Arms (2)
MRI simulation
EXPERIMENTALMRI simulation with a Virtual Reality headset
Standard medical care
NO INTERVENTIONStandard medical care
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Coralie SERVAIT, PI
CHRU de Nancy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiology technician
Study Record Dates
First Submitted
August 5, 2020
First Posted
September 2, 2020
Study Start
November 4, 2020
Primary Completion
October 18, 2023
Study Completion
October 18, 2023
Last Updated
January 30, 2025
Record last verified: 2024-02