Use of an Infotainment System in MRI in Patients Suffering From Unexpected Anxiety. (USIA)

January 14, 2026 updated by: Centre Hospitalier Universitaire Dijon

MRI scans are now considered essential for diagnosing or monitoring disease, and as a result, the number of MRI scans has increased significantly in recent years.

Nevertheless, these routine examinations remain a source of apprehension and anxiety for some people.

The objective of this study is to compare two methods of care, enabling anxious individuals to complete their MRI examination and obtain images of sufficient quality for the radiologist to read and interpret.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals who have given their verbal consent
  • Individuals over the age of 18
  • Hospitalized or ambulatory individuals who are able-bodied and scheduled to undergo a brain MRI scan on the 1.5T A MRI machine at the Dijon University Hospital.
  • Individuals reporting anxiety about brain MRI for the first time upon admission by the radiology technician.

Exclusion Criteria:

  • Persons not affiliated with or not covered by a social security system
  • Persons subject to legal protection measures (guardianship, trusteeship)
  • Persons subject to judicial protection measures
  • Women who know they are pregnant
  • Adults who are incapable or unable to give their consent
  • Persons with contraindications to MRI
  • Persons who have already undergone an MRI accompanied by hypnosis
  • Persons who do not speak French
  • Persons who cannot read French
  • Persons with cognitive disorders
  • Persons who have taken sedatives before the examination
  • Persons who regularly take anxiolytic medication and have increased their usual dose before the examination
  • Persons who have already participated in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Innovision©
Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire
Assessment of patient anxiety
Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis
Hypnosis or Innovision device
Active Comparator: Hypnosis control
Other: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire
Assessment of patient anxiety
Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis
Hypnosis or Innovision device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of brain MRI sequences reported as interpretable
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIGNOT AOIparaM 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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