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NCT Number: NCT05893121

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pierre Paul Riquet Hospital

Toulouse, 31000, France

Location status: Recruiting

Location contact

Frédéric BROUILLET

SUB_INVESTIGATOR

Jean-Pierre DESIRAT

CONTACT

[email protected]

05 34 55 74 75 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac coherence session

Other

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

Information note about MRI

Other

explanatory note about MRI examination

Primary outcomes

  1. Effect of a cardiac coherence session on the anxiety level

    Time frame: 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

Secondary outcomes

  1. MRI examination quality

    Time frame: 30 minutes

    The quality of the MRI examination will be measured at the end of the examination, blinded to the allocation group

  2. Physiological parameters

    Time frame: 30 minutes

    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.

  3. patient satisfaction

    Time frame: 30 minutes

    A satisfaction questionnaire will be used at the end of the MRI examination (2 questions).

  4. Economic evaluation

    Time frame: 30 minutes

    The time spent preparing the patient and the time related to the cardiac coherence consultation

  5. Other economic evaluation

    Time frame: 30 minutes

    The costs related to the imaging act from the point of view of the health insurance

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Pierre DESIRAT

CONTACT

[email protected]

0534557475 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: RESP-IRM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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