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

NCT07246746 — Not applicable, Recruiting, 50 participants, Centre Hospitalier Universitaire Dijon

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RegistryNCT07246746, acronym USIA
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, other
Enrollment50 (Estimated)
SponsorCentre Hospitalier Universitaire Dijon (Other)
ConditionsUnexpected Anxiety
InterventionsAssessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire, Anxiety support procedure according to randomization: Innovision© or Hypnosis (Other)
Datesstart 2026-01-12, primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2025-11-24, last updated 2026-01-15
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Unexpected Anxiety All trials of Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire All trials of Anxiety support procedure according to randomization: Innovision© or Hypnosis

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Experimental Innovision©ExperimentalOther: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire; Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis
Hypnosis controlActive comparatorOther: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire; Other: Anxiety support procedure according to randomization: Innovision© or Hypnosis
  • Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire (Other): Assessment of patient anxiety
  • Anxiety support procedure according to randomization: Innovision© or Hypnosis (Other): Hypnosis or Innovision device

+Outcome measures

Primary outcomes

  • Percentage of brain MRI sequences reported as interpretable [Baseline]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
CHU Dijon BourgogneDijonFranceRecruiting