New Simulation Care Pathway for Paediatric MRI Preparation
NCT07344753 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 114
Last updated 2026-02-23
Summary
Magnetic resonance imaging (MRI) is a common imaging procedure that is safe and non-invasive, as it relies on the use of different magnetic fields. It is the gold standard examination for a wide range of pathologies.
However, it has many disadvantages, including the repetitive noise produced by the coils during image acquisition sequences, which can cause discomfort. The noise level often exceeds 100 dB, while the noise exposure limit for workers is set at 87 dB. There is no regulatory limit for patients. Although it is relatively loud and quite unpleasant, this noise is not harmful to health and does not amplify, contrary to the perception that one may have in the tunnel. Noise-cancelling headphones and earbuds are strongly recommended for patients to reduce any discomfort that may result. In practice, the imaging department requires all patients to wear hearing protection.
Other disadvantages of MRI include confinement in a tunnel and the need to remain completely immobile for approximately six sequences, each of 2 to 5 minutes in duration.
This can be problematic, particularly for patients suffering from pain or respiratory failure, or for agitated individuals who find it difficult to remain motionless in a lying position for long periods of time.
These various issues are particularly relevant in the paediatric population, for whom MRI is the preferred imaging technique due to its safety in terms of radiation exposure.
The specific characteristics of this population require more complex patient management due to the particular constraints of MRI. Acceptance of the following four points appears to be key to its successful implementation: lying down, with the head in a tunnel, intense and repeated noises, and strict immobility for at least 30 minutes. Without these conditions, the images recorded will not provide reliable results that can be used for diagnosis.
To meet these constraints, at Nantes University Hospital, general anaesthesia was routinely administered to children aged 3 to 6 until September 2023. This ensures a 100% success rate for the examination, but it is not a trivial procedure for the child and is stressful for their parents. Since then, a light sedation protocol has been offered as part of the care pathway. This involves the child taking medication one hour and then thirty minutes before the MRI scan to calm them down until they fall asleep.
Unfortunately, access to this MRI under light sedation or general anaesthesia complicates the appointment booking process, as it requires the presence of a medical team during dedicated shifts.
MRI scans under light sedation are scheduled for three slots per week. At the end of 2025, the waiting time was four months for light sedation and six months for general anaesthesia.
In order to improve and speed up the care of children who need to perform an MRI scan, a specific consultation with an immersive four-module programme has been designed at Nantes University Hospital with the aim of optimising the chances of success of the examination without general anaesthesia or sedation, thereby:
* Reduce waiting times for appointments, and thus reduce the period of stress for parents awaiting a diagnosis for their child.
* Reduce the time required for the examination. Indeed, an examination under light sedation considerably lengthens the treatment time, with a sedation onset time of approximately 1.5 hours.
* Increasing the success rate of MRI scans under light sedation following failure without sedation.
This innovative approach is based on an immersive experience in the form of a course consisting of four modules designed to help children practise four areas that can be challenging for them (immersion in a tunnel, loud noise, the constraints of specific equipment, and immobility). These modules are themed around the marine world, in line with the already approved paediatric radiology programme. It will be offered to children aged 3 to 6 with no cognitive or behavioural disorders.
The modules will be installed in a paediatric consultation room and will be used for half a day each month. When not needed, they'll be put away so the room can be used for consultations.
The aim of our pilot study is to assess the impact of this immersive journey on the success of an MRI scan without general anaesthesia or sedation.
Conditions
- Magnetic Resonance Imaging (MRI)
Interventions
- OTHER
-
Realization of the immersive experience
The immersive experience is divided into four modules, to be completed in the following order: First module: the tunnel (confinement) The child lies down on the mat, and the paramedical staff slowly slide the tunnel over them until their head is in the middle of it. Second module: noise. The child must press three illuminated buttons that produce the sounds of an MRI scan (recorded by us). Third module: the diving suit (equipment constraints) In order to use the submarine, the child must wear noise-cancelling headphones. They stand against the wall and the professional helps them to put the headphones on correctly over their ears. Fourth module: static position (immobility). The child lies down on a mat in a mould that fits their size (3 sizes available). They watch an animated film lasting 3 minutes 30 seconds (the average duration of an MRI sequence). Their body must not move out of the mould, proving that they have managed to remain still.
- OTHER
-
Completion of study questionnaires
Assessment of the child's satisfaction with each module using a simplified 3-point scale adapted to very young children (positive, neutral, negative experience) Assessment of the guardian's satisfaction through a series of questions following the immersive experience and the MRI scan
- OTHER
-
Questioning the child's emotional feelings
The child's emotional response, recorded using an emotion weather chart (4 icons) before and after the immersive experience and before and after the MRI scan.
Sponsors & Collaborators
-
Direction Générale de l'offre de Soins (DGOS)
collaborator UNKNOWN -
Nantes University Hospital
lead OTHER
Principal Investigators
-
Sylvie Ribbe · Nantes University Hospital
-
Lucie Breteau · Nantes University Hospital
-
Stéphanie Hatron · Nantes University Hospital
Eligibility
- Min Age
- 36 Months
- Max Age
- 72 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-11
- Primary Completion
- 2028-08-15
- Completion
- 2028-08-15
Countries
- France
Study Locations
More Related Trials
-
Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging
NCT06467045 ·Status: RECRUITING
-
Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
NCT04812210 ·Status: COMPLETED
-
Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children
NCT05108441 ·Status: COMPLETED ·Phase: NA
-
Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
NCT03055455 ·Status: COMPLETED
-
Functional MR Urography
NCT00301470 ·Status: COMPLETED ·Phase: PHASE4
-
Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
NCT06097377 ·Status: COMPLETED
-
Feasibility of Magnetic-end Double-J Ureteral Stent Use in Children
NCT04384939 ·Status: COMPLETED ·Phase: NA
-
Magnetic Resonance Imaging Autopsy Study
NCT01417962 ·Status: COMPLETED
-
Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children
NCT04507581 ·Status: COMPLETED
-
Single Time Management Diseases in Pediatric Traumatology
NCT03852095 ·Status: COMPLETED
-
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
NCT06370624 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle
NCT03507972 ·Status: TERMINATED ·Phase: NA
-
Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
NCT02792348 ·Status: UNKNOWN
-
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
NCT02803671 ·Status: COMPLETED ·Phase: NA
-
Functional MRI Evaluation in Pyeloureteral Junction Syndrome in Children
NCT05498532 ·Status: UNKNOWN
-
High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp
NCT03312348 ·Status: COMPLETED ·Phase: NA
-
Radiation Dose of Pediatric Patients During Ureteroscopy
NCT02895711 ·Status: COMPLETED
-
A Integrated Study in Pediatric Patients with Cardiomyopathy
NCT06641830 ·Status: ENROLLING_BY_INVITATION
-
Infrared Thermography for Assessment of Caudal Block in Children
NCT02907957 ·Status: COMPLETED ·Phase: NA
-
Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
NCT04007627 ·Status: UNKNOWN
-
Development of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations
NCT03440827 ·Status: UNKNOWN ·Phase: NA
-
LUMIERE on the FETUS
NCT04142606 ·Status: RECRUITING
-
Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
NCT03194763 ·Status: COMPLETED
-
Magnetic Resonance Imaging (MRI) of Appendicitis in Children
NCT00723788 ·Status: COMPLETED ·Phase: NA
-
Ultrafast Ultrasound Imaging in Pediatric Cardiology
NCT07255144 ·Status: RECRUITING