Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination (RESP-IRM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Other: Information note about MRI; Other: Cardiac coherence session

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jean-Pierre DESIRAT; Phone Number: +33 0534557475; Email: desirat.jp@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • Pierre Paul Riquet Hospital
    • Contact: Jean-Pierre DESIRAT; Phone Number: +33 05 34 55 74 75; Email: desirat.jp@chu-toulouse.fr
    • Sub-Investigator: Frédéric BROUILLET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

subject with moderate or high anxiety ( score ≥ 4 ) in relation to MRI exam

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; subjects who received information about MRI examination	Other: Information note about MRI; explanatory note about MRI examination
Experimental; Subjects who received information about MRI examination and one cardiac coherence session	Other: Information note about MRI; explanatory note about MRI examination; Other: Cardiac coherence session; A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jean-Pierre DESIRAT, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cardiac coherence; improving patient management
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RC31/22/0483

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No