New Simulation Care Pathway for Paediatric MRI Preparation

NCT07344753 | Recruiting

• 1 other identifier: RC25_0371
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Magnetic Resonance Imaging (MRI); Immersive experience; Paediatric MRI

Outcome Measures

Primary Outcomes (1)

• Assess the usefulness of an immersive experience in the success of an MRI scan on the first attempt without general anaesthesia or sedation for children aged 3 to 6 years.

  Our main criteria is obtaining a diagnosis (pathological or otherwise) following an MRI scan using the immersive approach. Children who have not completed the immersive approach and therefore have not undergone an MRI scan without general anaesthesia or sedation will be considered to have been unsuccessful. In addition, children who have successfully completed the immersive pathway but whose MRI scan without general anaesthesia or sedation does not result in a diagnosis (and for whom an additional MRI scan must therefore be scheduled) will be considered unsuccessful.

  14 days

Secondary Outcomes (7)

• Assess the success rate of MRI without general anaesthesia or sedation in the subgroup of children who successfully completed the immersive experience.

  14 days

• Description of the implementation of the four modules of the immersive experience (proportion of patients who failed each module)

  14 days

• Assessment of the patient's emotional response to the immersive experience and the MRI scan with an emotional weather forecast (4 icons) before and after the immersive experience, as well as before and after the MRI scan

  14 days

• Assess patient satisfaction with the immersive experience based on a simplified 3-point facial expression scale adapted to very young children (positive, neutral, negative experiences)

  1 day

• Research of factors associated with successful MRI without general anaesthesia or sedation.

  14 days

Study Arms (1)

Study patient

Other: Realization of the immersive experience; Other: Completion of study questionnaires; Other: Questioning the child's emotional feelings

Interventions

Realization of the immersive experience OTHER

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.

Study patient

Completion of study questionnaires OTHER

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

Study patient

Questioning the child's emotional feelings OTHER

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.

Study patient

Eligibility Criteria

• Age: 36 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study will focus on children aged between 3 and 6 years old who are scheduled to undergo an MRI scan (any anatomical region).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Direction Générale de l'offre de Soins (DGOS): collaborator

Study Sites (1)

CHU Nantes

Nantes, France

RECRUITING

Study Officials

• Sylvie Ribbe

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Lucie Breteau

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Stéphanie Hatron

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sponsor Department

CONTACT

02 53 48 28 35; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

FR (1)