Pierre Paul Riquet Hospital
Toulouse, 31000, France
Location status: Recruiting
NCT Number: NCT05893121
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Toulouse, 31000, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Exclusion criteria
A cardiac coherence session consists of an exercise of six breaths per minute during five minutes.
explanatory note about MRI examination
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
Time frame: 30 minutes
The quality of the MRI examination will be measured at the end of the examination, blinded to the allocation group
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.
Time frame: 30 minutes
A satisfaction questionnaire will be used at the end of the MRI examination (2 questions).
Time frame: 30 minutes
The time spent preparing the patient and the time related to the cardiac coherence consultation
Time frame: 30 minutes
The costs related to the imaging act from the point of view of the health insurance
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Evaluating the Contribution of a Cardiac Coherence Session to Reducing Patients' Anxiety During a Medical Magnetic Resonance Imaging Examination
Acronym: RESP-IRM
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.
Published trials that share one or more normalized conditions with this study.
NCT07692269
Anxiety, Anxiety Disorders
Beijing, Beijing Municipality, China
View Trial DetailsNCT05511909
Anxiety, Anxiety Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT07727434
Anxiety, Anxiety Disorders
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07717723
Anxiety, Anxiety Disorders
Sacramento, California, United States
View Trial Details