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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | MRI examination with Ambient Experience with paediatric content |
|
| Control group | No Intervention | MRI examination without Ambient Experience (standard of care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambient Experience | Behavioral | MRI examination with Ambient Experience |
|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Staff experience with the ambient experience system and workflow satisfaction | Measured by using self-constructered items, 5 point Likert scales, with higher ratings indicating a better experience and higher satisfaction. | At study start 5 min. and study end 5 min. |
| Observed operational efficiency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanae van der Vleuten- Chraibi | Philips Electronics Nederland B.V. acting through Philips CTO organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium | ||
| Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40613840 | Derived | van der Vleuten-Chraibi S, Nauts S, Baranska D, Inarejos Clemente EJ, Sterup Bovin J, Najafi N, Luetkens JA, Alison M, Biermann HM, Peckman F, Saini P. Magnetic resonance imaging related anxiety and workflow: impact of a child-friendly audio-visual intervention. Pediatr Radiol. 2025 Aug;55(9):1934-1942. doi: 10.1007/s00247-025-06308-0. Epub 2025 Jul 4. |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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 |
Observed cooperation of the patient and duration of preparing the patient for the MRI examination.This will be measured by using 5-point Likert scales, with higher ratings indicating a lower efficiency. |
| 5 minutes depending on the MRI scans that have to be made |
| Measured operational efficiency | Duration of the MRI examination, number of rescans required, and number of pauzes required. Numerical log data derived from the MRI server. | 30 up to 60 minutes depending on the entire length of the MRI scans that have to be made |
| Clinical patient outcome | Reported image quality by the MRI tech and the ability to perform the planned awake scan successful or not | During MRI scan, ca 30 minutes |
| Herlev |
| 2730 |
| Denmark |
| Hôpital Robert Debré Paris | Paris | 75019 | France |
| Das Universitätsklinikum Bonn (UKB) | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Polish Mother's Hospital / Institute of Polish Mother's Health Center | Lodz | 93-338 | Poland |
| Hospital de Sant Joan de Déu Barcelona | Esplugues de Llobregat | Barcelona | 08950 | Spain |