Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017947
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-03-16
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
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MuSCA
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 60000 to 65000 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 80000 and 100000 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 85 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 485 in patients with chest pain andor 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
The incidence of ACS is estimated between 80000 and 100000 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 85 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 485 in patients with chest pain andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None