Contribution of Hypnosis on Image Quality in Cardiac MRI

NCT ID: NCT05999578

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-05-31

Brief 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.

Detailed 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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Anxious patients with hypnosis

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

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: OTHER

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

Anxious patients without hypnosis

Cardiac MRI exam accordingly to usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non anxious patients

Cardiac MRI exam accordingly to usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnosis

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amandine ANDRE-BILLEAU

Role: CONTACT

amandine.andre@chu-bordeaux.fr

+33557820000 ext. 74634

Facility Contacts

Amandine ANDRE-BILLEAU

Role: primary

amandine.andre@chu-bordeaux.fr

+33557820000 ext. 74634

Other Identifiers

CHUBX 2022/79

Identifier Type: -

Identifier Source: org_study_id