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

NCT07309328 | Not Yet Recruiting Phase 2

• 1 other identifier: MLC_2025_6
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  Day 1

Study Arms (2)

Cardiac Coherence Breathing Exercise During MRI

EXPERIMENTAL

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

Standard Care During MRI

NO INTERVENTION

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.

Interventions

cardiac coherence BEHAVIORAL

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

Cardiac Coherence Breathing Exercise During MRI

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Claustrophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12