Children's MRI Experience

Not Applicable

Completed

• Conditions: Behavior; Anxiety; Psychological Distress
• Interventions: Behavioral: Ambient Experience

• Registration Number: NCT05089955
• Lead Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Study Start: 2023-01-24
• Primary Completion: 2024-04-26
• Study Completion: 2024-05-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Ambient Experience	MRI examination with Ambient Experience with paediatric content

Primary Outcome Measures

Name	Time	Method
Child anxiety level	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium

Hôpital Robert Debré Paris; 🇫🇷 Paris, France

Herlev Hospital; 🇩🇰 Herlev, Denmark

Das Universitätsklinikum Bonn (UKB); 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

Polish Mother's Hospital / Institute of Polish Mother's Health Center; 🇵🇱 Łódź, Poland

Hospital de Sant Joan de Déu Barcelona; 🇪🇸 Esplugues De Llobregat, Barcelona, Spain