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Clinical Trials/NCT05893121
NCT05893121
Recruiting
Not Applicable

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

University Hospital, Toulouse1 site in 1 country60 target enrollmentDecember 8, 2023
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University Hospital, Toulouse
Enrollment
60
Locations
1
Primary Endpoint
Effect of a cardiac coherence session on the anxiety level
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 8, 2023
End Date
March 30, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Effect of a cardiac coherence session on the anxiety level

Time Frame: 10 minutes

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

Secondary Outcomes

  • Economic evaluation(30 minutes)
  • Other economic evaluation(30 minutes)
  • Physiological parameters(30 minutes)
  • MRI examination quality(30 minutes)
  • patient satisfaction(30 minutes)

Study Sites (1)

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