Children's MRI Experience

Philips Clinical & Medical Affairs Global175 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

175

Conditions

Behavior Psychological Distress Anxiety

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (6)

UZ Brussel

Jette, Brussels Capital, Belgium

Herlev Hospital

Herlev, Denmark

Hôpital Robert Debré Paris

Paris, France

Das Universitätsklinikum Bonn (UKB)

Bonn, North Rhine-Westphalia, Germany

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

Lodz, Poland

Hospital de Sant Joan de Déu Barcelona

Esplugues de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

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.

Time frame: 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.

Time frame: After the scan, 5 minutes