Contribution of Hypnosis on Image Quality in Cardiac MRI

Anxiety Clinical Trial

— HYPNOLINE  

Official title:

Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999578
• Other study ID #: CHUBX 2022/79
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Amandine ANDRE-BILLEAU
• Phone: +33557820000
• Email: amandine.andre[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) = 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE < 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
• 18 years and older
• Highly effective contraception for women of childbearing potential, maintained during research procedures
• Informed consent
• Affiliated or beneficiary of health insurance

Exclusion Criteria:

• Contraindications to MRI and gadoline contrast medium
• Hearing impaired patients
• Patients who do not speak French
• Women who are pregnant or lactating
• Inability to agree to participate to the study
• Patient under legal protection

Related Conditions & MeSH terms

• Anxiety

Intervention

Other:
• Hypnosis
Hypnosis support before, during and at the end of cardiac MRI exam

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of cardiac MRI images	Likert score measurements	Baseline
Secondary	number of artifacts	The number of artifacts will be estimated with European CMR Registry objective score.	Baseline
Secondary	Diagnostic validation score	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.	Baseline
Secondary	Causality score measurement	Causality score measurement for examinations with a Likert score < 4	Baseline
Secondary	Overall duration	The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).	Baseline
Secondary	Number of repeated or interrupted sequences	The number of repeated or interrupted sequences (by the Radiographer or the patient).	Baseline
Secondary	Anxiety level	The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.	Baseline
Secondary	Post-MRI satisfaction score	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).	Baseline