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 (MuSCA)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Procedure: Music care

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis LEBON; Phone Number: +262262359000; Email: alexislebon974@gmail.com

Study Locations

• France
  • Île De La Réunion
    • Saint Pierre, Île De La Réunion, France, 97448
      • Recruiting
      • Centre Hospitalier Universitaire
      • Contact: Alexis LE BON
      • Principal Investigator: Alexis LEBON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 and over
• With an established or suspected Acute Coronary Syndrome diagnosis
• With a stable clinical condition at the initial assessment:
• Whose anxiety assessment is > or = 30/100 mm on the Visual Analogue Scale
• Having provided express, free and informed consent
• With an estimated transport time of at least > 30 minutes

Exclusion Criteria:

• Under guardianship, curatorship or judicial safeguard procedure
• With hearing and visual impairments
• Participating in another clinical trial or having already been included in this study.
• Supported by helicopter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musical intervention	Procedure: Music care; 20 min music listening during transportation to hospital
No Intervention: standard process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety change	This is to assess whether a 20-minute musical intervention associated with the usual care would reduce the anxiety of the patient suffering from an acute coronary syndrome in pre-hospital during his transfer to a health establishment. (intervention group) compared to usual management alone (control group). measurement méthod : analog visual scale	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain change	assess whether a musical intervention associated with the usual care allows a reduction, during the transfer to a health establishment of the pain score (Numerical Scale)	20 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): June 11, 2025
• Study Completion (Estimated): June 11, 2026

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Disease; Syndrome; Emergencies; Acute Coronary Syndrome
• Other Study ID Numbers: 2023/CHU/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No