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

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: MRI; Claustrophobia

Treatments: Behavioral: cardiac coherence

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07309328

MLC_2025_6

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Cardiac Coherence Breathing Exercise During MRI

Experimental group

Description:

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.

Treatment:

Behavioral: cardiac coherence

Standard Care During MRI

No Intervention group

Description:

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.