Children's MRI Experience

Study Overview
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Brief Summary
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The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting. The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.

Official Title
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User Evaluation New Ambient Experience Content

Conditions
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Behavior, Psychological Distress, Anxiety

Intervention / Treatment
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* Behavioral: Ambient Experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 6 and 12 years old Scheduled for a head-first MRI scan Parent/guardian and child speak and read the local language. Positive judgement by on-site PI/(co-) investigator for awake scanning Exclusion Criteria: General anesthesia Clinically diagnosed cognitive, or developmental disorder (e.g. ADHD, ASD) or neurological problems that prevent the ability to lie/hold still for an MRI scan while awake Previous MRI examination with Philips Ambient Experience

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>MRI examination with Ambient Experience with paediatric content | Behavioral: Ambient Experience<br>* MRI examination with Ambient Experience<br>|
| No Intervention: Control group<br>MRI examination without Ambient Experience (standard of care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child anxiety level | Change of anxiety experienced by the child, measured with questions before and after the scan. A Venham picture preference scale will be used, the range is not applicable as it indicates their state of anxiety. | The visit on the imaging department; before and after the examination. This is estimated to be 30 up to 60 minutes, depending on the MRI scans that have to be made. | 
| Child anxiety level | Change of anxiety level of child measured with an observational scale by staff or (co-) investigator before and during the scan. By using a modified yale preoperative anxiety scale, with a range from 22.92 to 100; higher values indicating greater anxiety. | The visit on the imaging department; before and during the examination. This is estimated to be 10 up to 30 minutes, depending on the MRI scans that have to be made. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immersiveness and engagement with Ambient Experience and content | Measured with likability of the experience and characters. This scale is self-constructed for the purpose of measuring how much the child likes the characters and how much that influenced their experience of the scan. | After the scan, 5 minutes. | 
| Parent/ Guardian satisfaction | Will be measured with self-constructed 6-point Likert scale, with higher ratings indicating a higher satisfaction. | After the scan, 5 minutes |