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

NCT ID: NCT07246746

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unexpected Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Innovision©

Group Type EXPERIMENTAL

Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire

Intervention Type OTHER

Assessment of patient anxiety

Anxiety support procedure according to randomization: Innovision© or Hypnosis

Intervention Type OTHER

Hypnosis or Innovision device

Hypnosis control

Group Type ACTIVE_COMPARATOR

Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire

Intervention Type OTHER

Assessment of patient anxiety

Anxiety support procedure according to randomization: Innovision© or Hypnosis

Intervention Type OTHER

Hypnosis or Innovision device

Interventions

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Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire

Assessment of patient anxiety

Intervention Type OTHER

Anxiety support procedure according to randomization: Innovision© or Hypnosis

Hypnosis or Innovision device

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas MIGNOT

Role: CONTACT

03 80 29 30 31

Facility Contacts

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Nicolas MIGNOT

Role: primary

03 80 29 30 31

Other Identifiers

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MIGNOT AOIparaM 2023

Identifier Type: -

Identifier Source: org_study_id

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