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Children's MRI Experience

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Philips

Status

Completed

Conditions

Behavior
Anxiety
Psychological Distress

Treatments

Behavioral: Ambient Experience

Study type

Interventional

Funder types

Industry

Identifiers

NCT05089955
ICBE-S-000195

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

175 participants in 2 patient groups

Intervention group
Experimental group
Description:
MRI examination with Ambient Experience with paediatric content
Treatment:
Behavioral: Ambient Experience
Control group
No Intervention group
Description:
MRI examination without Ambient Experience (standard of care)

Trial contacts and locations

6

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Central trial contact

Sanae van der Vleuten- Chraibi

Data sourced from clinicaltrials.gov

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