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

NCT ID: NCT05893121

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2026-03-30

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.

Conditions

Anxiety

Keywords

cardiac coherence; improving patient management

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental

Subjects who received information about MRI examination and one cardiac coherence session

Cardiac coherence session

Intervention Type: OTHER

A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.

Information note about MRI

Intervention Type: OTHER

explanatory note about MRI examination

Control

subjects who received information about MRI examination

Information note about MRI

Intervention Type: OTHER

explanatory note about MRI examination

Interventions

Cardiac coherence session

A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.

Intervention Type: OTHER

Information note about MRI

explanatory note about MRI examination

Intervention Type: OTHER

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre DESIRAT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Pierre Paul Riquet Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Pierre DESIRAT

Role: CONTACT

Phone: 0534557475

Email: desirat.jp@chu-toulouse.fr

Facility Contacts

Jean-Pierre DESIRAT

Role: primary

Other Identifiers

RC31/22/0483

Identifier Type: -

Identifier Source: org_study_id