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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age7+
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • cardiac coherence

    Behavioral

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Cardiac Coherence Breathing Exercise During MRIExperimental treatment 1 intervention
Group B: Standard Care During MRINo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of interpretable MRI exams with good image quality, rated blindly by a radiologist

This outcome measures the proportion of MRI exams considered interpretable and of good quality, based on image assessment by a radiologist blinded to the intervention group. Any exam for which all planned sequences could not be acquired is considered a failure. Each image is scored on a 5-point scale: No artifacts; Minor artifacts (edges only), not interfering with interpretation; Moderate artifacts, not interfering with interpretation; Significant artifacts, partial interpretation possible; Major artifacts, hindering interpretation. An exam is considered of good quality if all images are rated as 1 or 2.

Time frame
Day 1

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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