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

T

Toulouse University Hospital

Status

Enrolling

Conditions

Anxiety

Treatments

Other: Information note about MRI
Other: Cardiac coherence session

Study type

Observational

Funder types

Other

Identifiers

NCT05893121
RC31/22/0483

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

60 participants in 2 patient groups

Control
Description:
subjects who received information about MRI examination
Treatment:
Other: Information note about MRI
Experimental
Description:
Subjects who received information about MRI examination and one cardiac coherence session
Treatment:
Other: Cardiac coherence session
Other: Information note about MRI

Trial contacts and locations

1

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Central trial contact

Jean-Pierre DESIRAT

Data sourced from clinicaltrials.gov

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