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

NCT ID: NCT04536116

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2023-10-18

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.

Conditions

Claustrophobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MRI simulation

MRI simulation with a Virtual Reality headset

Group Type: EXPERIMENTAL

Virtual Reality headset

Intervention Type: DEVICE

MRI simulation with a Virtual Reality headset

Standard medical care

Standard medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality headset

MRI simulation with a Virtual Reality headset

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Servait Coralie

Radiology technician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Coralie SERVAIT, PI

Role: PRINCIPAL_INVESTIGATOR

CHRU de Nancy

Locations

CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2019-A03072-55

Identifier Type: -

Identifier Source: org_study_id