Virtual Reality as Anxiety Management Tool for Preparing Children for MR Exam (LIVE)

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Claustrophobia

Treatments

Device: Virtual Reality headset

Study type

Interventional

Funder types

Other

Identifiers

NCT04536116
2019-A03072-55

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

MRI simulation
Experimental group
Description:
MRI simulation with a Virtual Reality headset
Treatment:
Device: Virtual Reality headset
Standard medical care
No Intervention group
Description:
Standard medical care

Trial contacts and locations

1

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Central trial contact

Claire BANASIAK

Data sourced from clinicaltrials.gov

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