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

NCT ID: NCT07309328

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Claustrophobia; MRI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

cardiac coherence

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cardiac coherence

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MLC_2025_6

Identifier Type: -

Identifier Source: org_study_id