CHU Bordeaux
Bordeaux, France
Location status: Recruiting
NCT Number: NCT05999578
The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bordeaux, France
Location status: Recruiting
Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.
In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.
However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.
Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.
The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hypnosis support before, during and at the end of cardiac MRI exam
Time frame: Baseline
Likert score measurements
Time frame: Baseline
The number of artifacts will be estimated with European CMR Registry objective score.
Time frame: Baseline
The diagnostic validation score for the entire examination (and not sequence by sequence) makes it possible to define whether, despite the presence of artifacts, the examination makes it possible to answer the question initially asked in the examination request.
Time frame: Baseline
Causality score measurement for examinations with a Likert score < 4
Time frame: Baseline
The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).
Time frame: Baseline
The number of repeated or interrupted sequences (by the Radiographer or the patient).
Time frame: Baseline
The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.
Time frame: Baseline
The post-MRI satisfaction score will be estimated from the patient by a visual analog scale rated from 0 (not at all satisfied) to 10 (very satisfied).
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
Acronym: HYPNOLINE
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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