Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination

Study Overview
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Brief Summary
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The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.

Detailed Description
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Although Magnetic Resonance Imaging (MRI) is considered to be biologically safe and painless, the examination is often perceived by patients as difficult to bear, causing a great deal of anxiety due to the various constraints: the upper half of the body, including the head, positioned in a tube with a circumference of approximately 70 cm, relatively long duration, immobilization and even restraint. However, all these conditions are necessary to obtain good quality images, which are essential for the interpretation of the examination for diagnostic purposes by the clinicians. The anxiety of patients linked to the performance of an MRI examination and its negative effects are documented in the literature. According to some authors, 71% of the professionals surveyed stated that anxiety was a common problem in their MRI centre and 19% stated that it regularly disrupted the examination. It is estimated that 10% of the motion artefacts present on MRI examinations are caused by anxiety-related motor agitation, making image quality difficult to exploit. Thus, every day, many MRI examinations are cancelled, interrupted, or of poor quality due to movement and difficult to interpret. All these examinations must therefore be rescheduled, with delays that can be several months long. Among these non-drug methods, cardiac coherence seems promising. This method is recent, non-invasive, of short duration, very easy to implement and requires little training for users. The present study hypothesize that a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, could make it possible to reduce their level of anxiety and thus improve the course of the examination.

Official Title
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Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination

Conditions
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Anxiety

Intervention / Treatment
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* Other: Cardiac coherence session
* Other: Information note about MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person affiliated to or benefiting from a social security scheme; Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research); Patient to undergo an MRI examination of the upper half of the body Patient over 18 years old Patient with a high level of anxiety (score ≥ 4) in relation to MRI Non-inclusion Criteria: Patient under legal protection or under another protection regime (guardianship, curatorship). Sedated or unconscious patient Patient performing an emergency MRI examination Patient with a level of French language that does not allow sufficient understanding for the completion of questionnaires Exclusion criteria: - STAI Y-A score < 46 (insignificant or low anxiety)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>subjects who received information about MRI examination | Other: Information note about MRI<br>* explanatory note about MRI examination<br>|
| Experimental<br>Subjects who received information about MRI examination and one cardiac coherence session | Other: Cardiac coherence session<br>* A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.<br>Other: Information note about MRI<br>* explanatory note about MRI examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of a cardiac coherence session on the anxiety level | The anxiety level will be measured by the Y-A form of the Spielberger State-Trait Anxiety Inventory (French version adapted from the State-Trait Anxiety Inventory - STAI) in all patients before the MRI examination is performed | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI examination quality | The quality of the MRI examination will be measured at the end of the examination, blinded to the allocation group | 30 minutes | 
| Physiological parameters | Physiological parameters reflecting the patients' level of anxiety will be measured in all patients before the MRI examination is carried out; before and after reading an information document and performing cardiac coherence for patients in the experimental group, after reading the information document for the control group. | 30 minutes | 
| patient satisfaction | A satisfaction questionnaire will be used at the end of the MRI examination (2 questions). | 30 minutes | 
| Economic evaluation | The time spent preparing the patient and the time related to the cardiac coherence consultation | 30 minutes | 
| Other economic evaluation | The costs related to the imaging act from the point of view of the health insurance | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac coherence, improving patient management