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Not yet recruiting NCT07309328

Evaluation of the Effectiveness of a Cardiac Coherence Exercise on MRI Success and Image Quality in Claustrophobic Patients

Phase II / Phase III Interventional Claustrophobia MRI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiac coherence.
Who it may be relevant to
Registry conditions: Claustrophobia, MRI. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Claustrophobia, an intense fear of confined spaces, can significantly impair the success of MRI examinations by causing patient movement or early termination of the scan, leading to poor image quality. Cardiac coherence, a breathing technique aimed at synchronizing heart rate and reducing anxiety, has shown benefits in stress management. This randomized controlled trial aims to evaluate whether the use of a guided cardiac coherence exercise during MRI can improve exam success rates and image quality in self-reported claustrophobic patients compared to standard care (cartoons for children, music for adults). The primary outcome is the proportion of interpretable MRI scans with good-quality images, assessed blindly by a radiologist. Secondary outcomes include exam duration, use of the emergency call button, patient satisfaction, and perceived comfort. A total of 220 patients aged 7 years and older will be enrolled over 12 months at the Fondation Adolphe de Rothschild Hospital.

Interventions

  • Behavioral cardiac coherence
    The exercise consists of slow, rhythmic breathing guided by visual and auditory cues designed to induce a state of physiological calm.

Primary outcome measures

  • Proportion of interpretable MRI exams with good image quality, rated blindly by a radiologist [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Patient aged 7 years or older
  • Undergoing a 1.5T or 3T MRI scan as part of routine care
  • Self-reported claustrophobia on the imaging department admission form
  • Explicit consent to participate in the study, provided by the patient or a legal representative (for minors)
  • Affiliated with or beneficiary of a social security system

Exclusion criteria

  • Patient under legal protection or guardianship
  • Pregnant or breastfeeding woman
  • Inability to complete questionnaires and/or perform the cardiac coherence exercise as judged by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07309328 · MLC_2025_6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗