Children's MRI Experience

User Evaluation New Ambient Experience Content

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Psychological Distress; Behavior
• Intervention / Treatment: Behavioral: Ambient Experience

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • UZ Brussel
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital
• France
  • Paris, France, 75019
    • Hôpital Robert Debré Paris
• Germany
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Das Universitätsklinikum Bonn (UKB)
• Poland
  • Łódź, Poland, 93-338
    • Polish Mother's Hospital / Institute of Polish Mother's Health Center
• Spain
  • Barcelona
    • Esplugues De Llobregat, Barcelona, Spain, 08950
      • Hospital de Sant Joan de Déu Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; MRI examination with Ambient Experience with paediatric content	Behavioral: Ambient Experience; MRI examination with Ambient Experience
No Intervention: Control group; MRI examination without Ambient Experience (standard of care)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Investigators: Study Director: Sanae van der Vleuten- Chraibi, Philips Electronics Nederland B.V. acting through Philips CTO organization

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ICBE-S-000195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No