Clinical trial NCT05893121: Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination
Official title: Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety
Keywords: cardiac coherence
improving patient management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subject with moderate or high anxiety ( score ≥ 4 ) in relation to MRI exam

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effect of a cardiac coherence session on the anxiety level
timeFrame: 10 minutes
Secondary outcomes:
measure: MRI examination quality
timeFrame: 30 minutes
measure: Physiological parameters
timeFrame: 30 minutes
measure: patient satisfaction
timeFrame: 30 minutes
measure: Economic evaluation
timeFrame: 30 minutes
measure: Other economic evaluation
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Pierre Paul Riquet Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Jean-Pierre DESIRAT
role: PRINCIPAL_INVESTIGATOR
References: