Simulation care pathway to prepare young children for MRI
20 000 Lieues Sous l'IRM - New Simulation Care Pathway for Paediatric MRI Preparation : Exploratory Descriptive Pilot Study
Nantes University Hospital · NCT07344753
This project will test an immersive simulation to help children aged 3 to 6 prepare for their first MRI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 36 Months to 72 Months |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Nantes) |
| Trial ID | NCT07344753 on ClinicalTrials.gov |
What this trial studies
This observational program offers an immersive pre‑MRI experience for children aged 36–72 months and collects parent/child questionnaires and brief emotional interviews. Participants complete the simulation before their scheduled MRI at CHU Nantes while staff record cooperation, comfort, and any need for sedation or repeat scanning. The protocol excludes children with significant cognitive or behavioral disorders, those who refuse the experience, non‑French speakers, and children attending for cochlear implant fitting. Study staff will analyze questionnaire responses and observed behaviors to describe how the simulation relates to the child’s tolerance of the MRI visit.
Who should consider this trial
Good fit: Children aged 36–72 months scheduled for their first MRI at CHU Nantes whose parent or guardian provides consent and who understand French are ideal candidates.
Not a fit: Children who are completely hostile to the experience, have cognitive or behavioral disorders, do not understand French, or are attending for cochlear implant validation are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could make MRI visits less stressful for young children and reduce the need for sedation.
How similar studies have performed: Previous work using mock scanners, virtual reality, and immersive preparation has shown reductions in pediatric MRI anxiety and lower sedation rates, so this builds on partially successful methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Children aged 36 to 72 months scheduled to undergo an MRI scan * Consent obtained from the child and their parent or legal guardian * Patient affiliated with the social security system, CMU * Children undergoing an MRI scan for the first time Exclusion criteria * Children who are completely hostile to the experience. * Children with cognitive or behavioural disorders. * Children or parents/guardians who do not understand French. * Children coming to validate the fitting of a cochlear implant
Where this trial is running
Nantes
- CHU Nantes — Nantes, France (RECRUITING)
Study contacts
- Principal investigator: Sylvie Ribbe — Nantes University Hospital
- Study coordinator: Sponsor Department
- Email: bp-prom-regl@chu-nantes.fr
- Phone: 02 53 48 28 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Magnetic Resonance Imaging, Immersive experience, Paediatric MRI