Use of an Infotainment System in MRI in Patients Sufferin... | NCT07246746

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

NCT07246746

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Recruiting

Last Update Posted

Jan 15, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Unexpected Anxiety

Interventions

Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire
Anxiety support procedure according to randomization: Innovision© or Hypnosis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2026Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Sep 26, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Nov 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Innovision©	Experimental		Other: 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 control	Active Comparator		Other: 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire	Other	Assessment of patient anxiety	Experimental Innovision©

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities