Contribution of Hypnosis on Image Quality in Cardiac MRI
HYPNOLINE
Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Apr 2025
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 15, 2025
September 1, 2025
2 years
August 11, 2023
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quality of cardiac MRI images
Likert score measurements
Baseline
Secondary Outcomes (7)
number of artifacts
Baseline
Diagnostic validation score
Baseline
Causality score measurement
Baseline
Overall duration
Baseline
Number of repeated or interrupted sequences
Baseline
- +2 more secondary outcomes
Study Arms (3)
Anxious patients with hypnosis
EXPERIMENTALHypnosis support before, during and at the end of cardiac MRI exam
Anxious patients without hypnosis
NO INTERVENTIONCardiac MRI exam accordingly to usual care
Non anxious patients
NO INTERVENTIONCardiac MRI exam accordingly to usual care
Interventions
Hypnosis support before, during and at the end of cardiac MRI exam
Eligibility Criteria
You may qualify if:
- 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.
- years and older
- Highly effective contraception for women of childbearing potential, maintained during research procedures
- Informed consent
- Affiliated or beneficiary of health insurance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 21, 2023
Study Start
April 15, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share