Virtual Reality As Anxiety Management Tool for Preparing Children for MR Exam

EvaLuation De L'apport De L'Irm Virtuelle Sur La Qualité De La Prise En Charge Des Enfants En Irm

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04536116

Acronym

LIVE

Enrollment

Registered

2020-09-02

Start date

2020-11-04

Completion date

2023-10-18

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claustrophobia

Brief summary

The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration. The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.

Interventions

DEVICEVirtual Reality headset

MRI simulation with a Virtual Reality headset

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Child from 6 to 12 years old, * Child who will have an MRI for the first time, * Outpatient child, * Child dependent on a parent affiliated to or beneficiary of a social security scheme, * Child who has received age-appropriate information on the organization of the research, * Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.

Exclusion criteria

* Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...), * Child with a contraindication to performing an MRI, * Child who has benefited from another MRI simulation system before (IRM en Jeu for instance) * Child's opposition to participate.

Design outcomes

Primary

Measure	Time frame	Description
Anxiety	2 hours	Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026