Children's MRI Experience

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2024-05-29

Brief Summary

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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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Detailed Description

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Conditions

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Behavior Psychological Distress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

MRI examination with Ambient Experience with paediatric content

Group Type EXPERIMENTAL

Ambient Experience

Intervention Type BEHAVIORAL

MRI examination with Ambient Experience

Control group

MRI examination without Ambient Experience (standard of care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ambient Experience

MRI examination with Ambient Experience

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No