Children's MRI Experience

Anxiety Clinical Trial

Official title:

User Evaluation New Ambient Experience Content

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089955
• Other study ID #: ICBE-S-000195
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: Sanae van der Vleuten- Chraibi
• Phone: +31-20-5669111
• Email: sanae.vander.vleuten-chraibi[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Behavior
• Psychological Distress

Intervention

Behavioral:
• Ambient Experience
MRI examination with Ambient Experience

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels
Denmark	Herlev Hospital	Herlev
France	Hôpital Robert Debré Paris	Paris
Germany	Das Universitätsklinikum Bonn (UKB)	Bonn	Nordrhein-Westfalen
Poland	Polish Mother's Hospital / Institute of Polish Mother's Health Center	Lódz
Spain	Hospital de Sant Joan de Déu Barcelona	Esplugues De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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
Other	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
Other	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
Primary	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.
Primary	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	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.
Secondary	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