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

Anxiety Clinical Trial

— RESP-IRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893121
• Other study ID #: RC31/22/0483
• Status: Recruiting
• Start date: December 8, 2023
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Toulouse
• Contact: Jean-Pierre DESIRAT
• Phone: 0534557475
• Email: desirat.jp[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Pierre Paul Riquet Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of a cardiac coherence session on the anxiety level	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	10 minutes
Secondary	MRI examination quality	The quality of the MRI examination will be measured at the end of the examination, blinded to the allocation group	30 minutes
Secondary	Physiological parameters	Physiological parameters reflecting the patients' level of anxiety will be measured in all patients before the MRI examination is carried out; before and after reading an information document and performing cardiac coherence for patients in the experimental group, after reading the information document for the control group.	30 minutes
Secondary	patient satisfaction	A satisfaction questionnaire will be used at the end of the MRI examination (2 questions).	30 minutes
Secondary	Economic evaluation	The time spent preparing the patient and the time related to the cardiac coherence consultation	30 minutes
Secondary	Other economic evaluation	The costs related to the imaging act from the point of view of the health insurance	30 minutes