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

NCT07309328 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-12-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

cardiac coherence

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

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309328 on ClinicalTrials.gov