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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Enrolling

Conditions

Unexpected Anxiety

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07246746
MIGNOT AOIparaM 2023

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Experimental Innovision©
Experimental group
Treatment:
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 group
Treatment:
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

Trial contacts and locations

1

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Central trial contact

Nicolas MIGNOT

Data sourced from clinicaltrials.gov

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