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)
Primary Purpose
Acute Coronary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music care
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard process
Musical intervention
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT06017947
First Posted
March 16, 2023
Last Updated
October 24, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT06017947
Brief Title
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
Acronym
MuSCA
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
June 11, 2025 (Anticipated)
Study Completion Date
June 11, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard process
Arm Type
No Intervention
Arm Title
Musical intervention
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Music care
Intervention Description
20 min music listening during transportation to hospital
Primary Outcome Measure Information:
Title
Anxiety change
Description
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
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Pain change
Description
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)
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis LEBON
Phone
+262262359000
Email
alexislebon974@gmail.com
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Saint Pierre
State/Province
Île De La Réunion
ZIP/Postal Code
97448
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis LE BON
First Name & Middle Initial & Last Name & Degree
Alexis LEBON
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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