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Evaluation of a Musical Intervention on the Anxiety of Patients With a Diagnosis of Acute Coronary Syndrome in a Pre-Hospital Emergency Situation: MuSCA Randomized Controlled Trial

Study acronym: MuSCA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jun 11, 2025 to Dec 11, 2026
    • Study completion date: Jun 11, 2026 to Dec 11, 2026
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 30, 2025 to Jun 11, 2025
    • Study completion date: Jun 30, 2026 to Jun 11, 2026
    • Start date changed from estimate of Sep 30, 2023 to Sep 12, 2023
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute coronary syndrome (ACS) encompasses a continuum of clinical situations secondary to acute myocardial ischemia. In France, it is a major health problem and represented 60,000 to 65,000 hospitalizations in 2010. In 2015, a diagnosis of ACS was made in 15 to 25% of patients consulting for chest pain in emergency medicine. The incidence of ACS is estimated between 80,000 and 100,000 new cases per year. At the University Hospital Center (CHU) of Réunion, acute chest pain is the leading cause of discharges from the Mobile Emergency and Resuscitation Service (SMUR). In 2019, it represented 23% of exits, 8.5% of which concerned SCAs. The SCA can be anxiety-provoking due to its unexpected and brutal nature. Pain related to myocardial ischemia generates anxiety. This increases when patients associate these pains with death. This anxiety is exacerbated by waiting times for care, especially for patients living in rural areas. In addition, conditions relating to medical care such as noise and the pre-hospital medical environment are perceived as influencing anxiety by patients. The prevalence of anxiety is high, ranging from 30 to 48.5%, in patients with chest pain and/or ACS. A 2020 meta-analysis revealed that anxious patients at the start of their ACS treatment had an increased risk of death, non-fatal myocardial infarction, rehospitalization, recurrence of ACS and the need for coronary revascularization repeated. Overall, ACS patients with anxiety have a 21% increased risk of mortality and 47% increased risk of adverse cardiovascular events compared to those without anxiety. Pre-hospital anxiolytic treatment is therefore essential and consists above all in reassuring the patient with ACS. Medicated anxiolytics are often combined with analgesics and recommended in front of a picture of agitation due to anxiety. However, negative effects may interfere, making clinical monitoring of these patients unsuitable. At the same time, several studies note that anxiety is underdiagnosed and undertreated in the care of these patients. In reducing the anxiety of patients with ACS, unconventional care techniques such as aromatherapy or touch massage have demonstrated their effectiveness. Music therapy is recognized in reducing the anxiety of patients in intensive care or Cardiology. To the knowledge, in France, the effect of a musical intervention on patients with pre-hospital ACS has not yet been studied. It is in this context that the MuSCA study takes place.
Trial Details
NCT Number NCT06017947
Lead Sponsor Centre Hospitalier Universitaire de la Réunion
Conditions
(from sponsor)
Acute Coronary Syndrome
Related terms Acute Coronary Syndrome
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov