Children's MRI Experience

NCT05089955 | Completed

• 1 other identifier: ICBE-S-000195
• Study Type: interventional
• Target: 175
• Locations: 6 countries
• Sites: 6

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.

Conditions

Behavior; Psychological Distress; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Immersiveness and engagement with Ambient Experience and content

  After the scan, 5 minutes.

• Parent/ Guardian satisfaction

  After the scan, 5 minutes

Other Outcomes (4)

• Staff experience with the ambient experience system and workflow satisfaction

  At study start 5 min. and study end 5 min.

• Observed operational efficiency

  5 minutes depending on the MRI scans that have to be made

• Measured operational efficiency

  30 up to 60 minutes depending on the entire length of the MRI scans that have to be made

Study Arms (2)

Intervention group

EXPERIMENTAL

MRI examination with Ambient Experience with paediatric content

Behavioral: Ambient Experience

Control group

NO INTERVENTION

MRI examination without Ambient Experience (standard of care)

Interventions

Ambient Experience BEHAVIORAL

MRI examination with Ambient Experience

Intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (6)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Hôpital Robert Debré Paris

Paris, 75019, France

Location

Das Universitätsklinikum Bonn (UKB)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Polish Mother's Hospital / Institute of Polish Mother's Health Center

Lodz, 93-338, Poland

Location

Hospital de Sant Joan de Déu Barcelona

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

• van der Vleuten-Chraibi S, Nauts S, Baranska D, Inarejos Clemente EJ, Sterup Bovin J, Najafi N, Luetkens JA, Alison M, Biermann HM, Peckman F, Saini P. Magnetic resonance imaging related anxiety and workflow: impact of a child-friendly audio-visual intervention. Pediatr Radiol. 2025 Aug;55(9):1934-1942. doi: 10.1007/s00247-025-06308-0. Epub 2025 Jul 4.

  PMID: 40613840 DERIVED

MeSH Terms

Conditions

Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sanae van der Vleuten- Chraibi

  Philips Electronics Nederland B.V. acting through Philips CTO organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 22, 2021
• Study Start: January 24, 2023
• Primary Completion: April 26, 2024
• Study Completion: May 29, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

FR (1); BE (1); DK (1); DE (1); PL (1); ES (1)