Use of an Infotainment System in MRI in Patients Suffering From Unexpected Anxiety.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Unexpected Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Percentage of brain MRI sequences reported as interpretable [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Dijon Bourgogne — Dijon
Identifiers
NCT: NCT07246746 · MIGNOT AOIparaM 2023