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

Last updated: November 28, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

Cardiac coherence session

Information note about MRI

Clinical Study ID

NCT05893121
RC31/22/0483
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 theresearch);

  • 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 understandingfor the completion of questionnaires

Exclusion

Exclusion criteria:

  • STAI Y-A score < 46 (insignificant or low anxiety)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Cardiac coherence session
Phase:
Study Start date:
December 08, 2023
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Pierre Paul Riquet Hospital

    Toulouse, 31000
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.