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Completed

NCT Number: NCT05089955

Children's MRI Experience

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.

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Key information

Conditions

Behavior Anxiety Anxiety Disorders Mental Disorders Psychological Distress

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel, Jette, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambient Experience

Behavioral

MRI examination with Ambient Experience

Primary outcomes

  1. Child anxiety level

    Time frame: 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.

    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.

  2. Child anxiety level

    Time frame: 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 outcomes

  1. Immersiveness and engagement with Ambient Experience and content

    Time frame: 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.

  2. Parent/ Guardian satisfaction

    Time frame: After the scan, 5 minutes

    Will be measured with self-constructed 6-point Likert scale, with higher ratings indicating a higher satisfaction.

Other outcomes

  1. Staff experience with the ambient experience system and workflow satisfaction

    Time frame: At study start 5 min. and study end 5 min.

    Measured by using self-constructered items, 5 point Likert scales, with higher ratings indicating a better experience and higher satisfaction.

  2. Observed operational efficiency

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

    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.

  3. Measured operational efficiency

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

    Duration of the MRI examination, number of rescans required, and number of pauzes required. Numerical log data derived from the MRI server.

  4. Clinical patient outcome

    Time frame: During MRI scan, ca 30 minutes

    Reported image quality by the MRI tech and the ability to perform the planned awake scan successful or not

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

User Evaluation New Ambient Experience Content

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2021
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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