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

NCT05893121 | Recruiting

• 1 other identifier: RC31/22/0483
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

cardiac coherence; improving patient management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MRI examination quality

  30 minutes

• Physiological parameters

  30 minutes

• patient satisfaction

  30 minutes

• Economic evaluation

  30 minutes

• Other economic evaluation

  30 minutes

Study Arms (2)

Control

subjects who received information about MRI examination

Other: Information note about MRI

Experimental

Subjects who received information about MRI examination and one cardiac coherence session

Other: Cardiac coherence session; Other: Information note about MRI

Interventions

Cardiac coherence session OTHER

A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.

Experimental

Information note about MRI OTHER

explanatory note about MRI examination

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subject with moderate or high anxiety ( score ≥ 4 ) in relation to MRI exam

You may qualify if:

• Person affiliated to or benefiting from a social security scheme;
• 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
• 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

You may not qualify if:

• \- STAI Y-A score \< 46 (insignificant or low anxiety)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Pierre Paul Riquet Hospital

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean-Pierre DESIRAT

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Pierre DESIRAT

CONTACT

0534557475; desirat.jp@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: June 7, 2023
• Study Start: December 8, 2023
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)