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Completed

NCT Number: NCT04536116

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

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.

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Key information

Conditions

Claustrophobia Anxiety Disorders Mental Disorders Phobic Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Virtual Reality Headset

Device

MRI simulation with a Virtual Reality headset

Primary outcomes

  1. Anxiety

    Time frame: 2 hours

    Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: LIVE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2020
Registry last updated
Jan 30, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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