Clinical trial NCT05999578: Contribution of Hypnosis on Image Quality in Cardiac MRI
Official title: Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: hypnosis
cardiac MRI
anxiety
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.

Detailed description: Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.

In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.

However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.

Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.

The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.

Eligibility criteria: Inclusion Criteria:

* Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE \< 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
* 18 years and older
* Highly effective contraception for women of childbearing potential, maintained during research procedures
* Informed consent
* Affiliated or beneficiary of health insurance

Exclusion Criteria:

* Contraindications to MRI and gadoline contrast medium
* Hearing impaired patients
* Patients who do not speak French
* Women who are pregnant or lactating
* Inability to agree to participate to the study
* Patient under legal protection

Primary outcomes:
measure: quality of cardiac MRI images
timeFrame: Baseline
Secondary outcomes:
measure: number of artifacts
timeFrame: Baseline
measure: Diagnostic validation score
timeFrame: Baseline
measure: Causality score measurement
timeFrame: Baseline
measure: Overall duration
timeFrame: Baseline
measure: Number of repeated or interrupted sequences
timeFrame: Baseline
measure: Anxiety level
timeFrame: Baseline
measure: Post-MRI satisfaction score
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: