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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MRI; Claustrophobia
• Intervention / Treatment: Behavioral: cardiac coherence

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Coherence Breathing Exercise During MRI; Participants in this arm will undergo their MRI scan while a guided cardiac coherence breathing exercise is played via audiovisual support (screen and headphones) throughout the procedure.	Behavioral: cardiac coherence; The exercise consists of slow, rhythmic breathing guided by visual and auditory cues designed to induce a state of physiological calm.
No Intervention: Standard Care During MRI; Participants in this arm will receive standard care during their MRI scan. As per routine clinical practice, children will be offered to watch a cartoon, and adults will be offered to listen to music during the examination. No specific breathing or relaxation exercise will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Claustrophobia
• Other Study ID Numbers: MLC_2025_6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No