Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac coherence session, Information note about MRI.
- Who it may be relevant to
- Registry conditions: Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination
Overview
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.
Interventions
- Other Cardiac coherence session
A cardiac coherence session consists of an exercise of six breaths per minute during five minutes. - Other Information note about MRI
explanatory note about MRI examination
Primary outcome measures
- Effect of a cardiac coherence session on the anxiety level [Time frame: 10 minutes]
Secondary outcome measures (5)
- MRI examination quality [Time frame: 30 minutes]
- Physiological parameters [Time frame: 30 minutes]
- patient satisfaction [Time frame: 30 minutes]
- Economic evaluation [Time frame: 30 minutes]
- Other economic evaluation [Time frame: 30 minutes]
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
\- STAI Y-A score < 46 (insignificant or low anxiety)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Pierre Paul Riquet Hospital — Toulouse
Identifiers
NCT: NCT05893121 · RC31/22/0483