Contribution of Hypnosis on Image Quality in Cardiac MRI
- Conditions
- Anxiety
- Interventions
- Other: Hypnosis
- Registration Number
- NCT05999578
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anxious patients with hypnosis Hypnosis Hypnosis support before, during and at the end of cardiac MRI exam
- Primary Outcome Measures
Name Time Method quality of cardiac MRI images Baseline Likert score measurements
- Secondary Outcome Measures
Name Time Method Anxiety level Baseline The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.
Causality score measurement Baseline Causality score measurement for examinations with a Likert score \< 4
Number of repeated or interrupted sequences Baseline The number of repeated or interrupted sequences (by the Radiographer or the patient).
Overall duration Baseline The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).
Post-MRI satisfaction score Baseline The post-MRI satisfaction score will be estimated from the patient by a visual analog scale rated from 0 (not at all satisfied) to 10 (very satisfied).
number of artifacts Baseline The number of artifacts will be estimated with European CMR Registry objective score.
Diagnostic validation score Baseline The diagnostic validation score for the entire examination (and not sequence by sequence) makes it possible to define whether, despite the presence of artifacts, the examination makes it possible to answer the question initially asked in the examination request.
Trial Locations
- Locations (1)
CHU Bordeaux
🇫🇷Bordeaux, France