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

Claustrophobia Clinical Trial

— LIVE  

Official title:

EvaLuation de l'Apport de l'Irm Virtuelle Sur la qualité de la Prise en Charge Des Enfants en Irm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536116
• Other study ID #: 2019-A03072-55
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Claustrophobia
• Phobic Disorders

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