Anxiety, Behavior, Psychological Distress
Conditions
Brief summary
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.
Interventions
BEHAVIORALAmbient Experience
MRI examination with Ambient Experience
Sponsors
Philips Electronics Nederland B.V. acting through Philips CTO organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child anxiety level | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immersiveness and engagement with Ambient Experience and content | After the scan, 5 minutes. | 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. |
| Parent/ Guardian satisfaction | After the scan, 5 minutes | Will be measured with self-constructed 6-point Likert scale, with higher ratings indicating a higher satisfaction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Staff experience with the ambient experience system and workflow satisfaction | At study start 5 min. and study end 5 min. | Measured by using self-constructered items, 5 point Likert scales, with higher ratings indicating a better experience and higher satisfaction. |
| Clinical patient outcome | During MRI scan, ca 30 minutes | Reported image quality by the MRI tech and the ability to perform the planned awake scan successful or not |
| Observed operational efficiency | 5 minutes depending on the MRI scans that have to be made | 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. |
| Measured operational efficiency | 30 up to 60 minutes depending on the entire length of the MRI scans that have to be made | Duration of the MRI examination, number of rescans required, and number of pauzes required. Numerical log data derived from the MRI server. |
Countries
Belgium, Denmark, France, Germany, Poland, Spain
Outcome results
None listed