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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04536116
Other study ID # 2019-A03072-55
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 4, 2020
Est. completion date November 4, 2023

Study information

Verified date July 2022
Source Central Hospital, Nancy, France
Contact Claire BANASIAK
Phone +33 3 83 15 42 78
Email c.banasiak@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 4, 2023
Est. primary completion date November 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual Reality headset
MRI simulation with a Virtual Reality headset

Locations

Country Name City State
France CHRU de Nancy Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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