Clinical Trials in France / NCT05893121
Recruiting
Observational
Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination
NCT05893121 · tracked via the Priya Life Science France tracker
Condition(s) studied
Anxiety
Investigational drug(s) / intervention(s)
Cardiac coherence sessionInformation note about MRI
Cardiac coherence session: A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.
Information note about MRI: explanatory note about MRI examination
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
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)
Primary outcome measure(s)
- Effect of a cardiac coherence session on the anxiety level — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Pierre Paul Riquet Hospital | Toulouse | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05893121 on ClinicalTrials.gov ↗ ← All trials in France