Magnetic Resonance Imaging (MRI)NCT07344753
New Simulation Care Pathway for Paediatric MRI Preparation
An observational study of Magnetic Resonance Imaging (MRI), run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 72 months
- Conditions the study is for
- Magnetic Resonance Imaging (MRI)
- What is being tested?
- Realization of the immersive experience, Completion of study questionnaires and Questioning the child's emotional feelings
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2026to 15 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 72 months
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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 who has not had an MRI since the age of 10 months 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes
Sylvie RIBBE, 02 40 08 48 86 ext. +33, sylvie.ribbe@chu-nantes.fr
Sylvie RIBBE
About this study
Official title: 20 000 Lieues Sous l'IRM - New Simulation Care Pathway for Paediatric MRI Preparation : Exploratory Descriptive Pilot Study
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.
Read more
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)
- Being tested
- Realization of the immersive experience, Completion of study questionnaires, Questioning the child's emotional feelings
- Keywords
- Magnetic Resonance Imaging (MRI), Immersive experience, Paediatric MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realization of the immersive experienceOther
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.
Completion of study questionnairesOther
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
Questioning the child's emotional feelingsOther
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 group | Role | What they receive |
|---|---|---|
| Study patient | Not described Receives: Other: Realization of the immersive experience; Other: Completion of study questionnaires; Other: Questioning the child's emotional feelings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Description of the implementation of the four modules of the immersive experience (proportion of patients who failed each module)
Measured: 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
Measured: 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)
Measured: 1 day
Research of factors associated with successful MRI without general anaesthesia or sedation.
The success of the MRI is defined in the main criteria. The factors studied to predict this will be: success or failure in each module of the immersion programme, the number of modules completed, the child's age, gender, schooling, childcare arrangements prior to schooling, and the positive or negative assessment of the immersion programme by the child and parents.
Measured: 14 days
Assessment of tutors' satisfaction with the immersive programme and the performance of MRI.
Measured: 14 days
Assessment of the hospital cost of the immersive procedure and MRI depending on the conditions (with/without general anaesthesia or sedation): professional time, cost of immersive modules, drugs/devices for anaesthesia/sedation and monitoring.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start11 Feb 2026
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging (MRI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Sylvie Ribbe, Principal investigator, Nantes University HospitalLucie Breteau, Principal investigator, Nantes University HospitalStéphanie Hatron, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344753
- Sponsor's protocol ID
- RC25_0371
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 20 000 Lieues Sous l'IRM - New Simulation Care Pathway for Paediatric MRI Preparation : Exploratory Descriptive Pilot Study
- ClinicalTrials.gov ID
- NCT07344753
- Acronym / sponsor ID
- RC25_0371
- Conditions
- Magnetic Resonance Imaging (MRI)
- Keywords
- Magnetic Resonance Imaging (MRI), Immersive experience, Paediatric MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patient | – | Other: Realization of the immersive experience, Other: Completion of study questionnaires, Other: Questioning the child's emotional feelings |
Who may qualify
- Ages
- 36 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (8 listed)
- 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 who has not had an MRI since the age of 10 months Exclusion criteria
- Children who are completely hostile to the experience.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realization of the immersive experienceThe 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 | Study patient |
| Completion of study questionnairesAssessment 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 | Study patient |
| Questioning the child's emotional feelingsThe 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. | Other | Study patient |
Primary outcome
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.
Time frame: 14 days
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.
7 secondary outcomes
Assess the success rate of MRI without general anaesthesia or sedation in the subgroup of children who successfully completed the immersive experience.
Time frame: 14 days
Description of the implementation of the four modules of the immersive experience (proportion of patients who failed each module)
Time frame: 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
Time frame: 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)
Time frame: 1 day
Research of factors associated with successful MRI without general anaesthesia or sedation.
Time frame: 14 days
Assessment of tutors' satisfaction with the immersive programme and the performance of MRI.
Time frame: 14 days
Assessment of the hospital cost of the immersive procedure and MRI depending on the conditions (with/without general anaesthesia or sedation): professional time, cost of immersive modules, drugs/devices for anaesthesia/sedation and monitoring.
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie Ribbe principal investigator
Nantes University Hospital
Lucie Breteau principal investigator
Nantes University Hospital
Stéphanie Hatron principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging (MRI), run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sponsor Department (02 53 48 28 35 ext. +33, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.