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
NCT ID: NCT06017947
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2023-09-12
2026-06-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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standard process
No interventions assigned to this group
Musical intervention
Music care
20 min music listening during transportation to hospital
Interventions
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Music care
20 min music listening during transportation to hospital
Eligibility Criteria
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Inclusion Criteria
* 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
* With hearing and visual impairments
* Participating in another clinical trial or having already been included in this study.
* Supported by helicopter
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de la Réunion
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire
Saint-Pierre, Île de La Réunion, France
Countries
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Central Contacts
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Facility Contacts
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Alexis LE BON
Role: primary
Other Identifiers
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2023/CHU/02
Identifier Type: -
Identifier Source: org_study_id
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