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

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.

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Key information

Conditions

Claustrophobia Anxiety Disorders MRI Mental Disorders Phobic Disorders

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cardiac coherence

Behavioral

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

Primary outcomes

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

Time frame: Day 1

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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: COCARI

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Dec 30, 2025
Registry last updated: Dec 30, 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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