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NCT Number: NCT05999578

Contribution of Hypnosis on Image Quality in Cardiac MRI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, France

Location status: Recruiting

Location contact

Amandine ANDRE-BILLEAU

CONTACT

[email protected]

+33557820000 ext. 74634

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hypnosis

Other

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

Primary outcomes

  1. quality of cardiac MRI images

    Time frame: Baseline

    Likert score measurements

Secondary outcomes

  1. number of artifacts

    Time frame: Baseline

    The number of artifacts will be estimated with European CMR Registry objective score.

  2. Diagnostic validation 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.

  3. Causality score measurement

    Time frame: Baseline

    Causality score measurement for examinations with a Likert score < 4

  4. Overall duration

    Time frame: Baseline

    The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).

  5. Number of repeated or interrupted sequences

    Time frame: Baseline

    The number of repeated or interrupted sequences (by the Radiographer or the patient).

  6. Anxiety level

    Time frame: Baseline

    The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.

  7. Post-MRI satisfaction score

    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).

Study contacts

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

Amandine ANDRE-BILLEAU

CONTACT

[email protected]

+33557820000 ext. 74634

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: HYPNOLINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Sep 15, 2025

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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