Clinical trial NCT05089955: Children's MRI Experience
Official title: User Evaluation New Ambient Experience Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Psychological Distress
Anxiety
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 175
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child anxiety level
timeFrame: 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.
measure: Child anxiety level
timeFrame: 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 outcomes:
measure: Immersiveness and engagement with Ambient Experience and content
timeFrame: After the scan, 5 minutes.
measure: Parent/ Guardian satisfaction
timeFrame: After the scan, 5 minutes
Other outcomes:
measure: Staff experience with the ambient experience system and workflow satisfaction
timeFrame: At study start 5 min. and study end 5 min.
measure: Observed operational efficiency
timeFrame: 5 minutes depending on the MRI scans that have to be made
measure: Measured operational efficiency
timeFrame: 30 up to 60 minutes depending on the entire length of the MRI scans that have to be made
measure: Clinical patient outcome
timeFrame: During MRI scan, ca 30 minutes
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Paris
country: France
facility: Hôpital Robert Debré Paris
city: Bonn
country: Germany
facility: Das Universitätsklinikum Bonn (UKB)
state: Nordrhein-Westfalen
city: Łódź
country: Poland
facility: Polish Mother's Hospital / Institute of Polish Mother's Health Center
city: Esplugues De Llobregat
country: Spain
facility: Hospital de Sant Joan de Déu Barcelona
state: Barcelona
Study officials:
affiliation: Philips Electronics Nederland B.V. acting through Philips CTO organization
name: Sanae van der Vleuten- Chraibi
role: STUDY_DIRECTOR
References: