Effect of Music on the Sedative Use During Coronary Angioplasty

Study Overview
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Brief Summary
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This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner.

Detailed Description
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This is a non-blinded, non-randomized controlled pilot study with patients who will be followed during their coronary angiography procedure and with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner. It is expected to enroll around 100 patients and this is estimated to be obtained in a period of 2 months approximately. Patients will be placed in the control group, without music intervention, or assigned to the music group. Assignment will be done in this manner due to limited availability of the hardware and software to the investigation team. Patients in both groups will be matched based on age, sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient will receive a standardized sedation in the traditional manner and at the discretion of the investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The primary study end points will be the consumptions in analgesics and hypnotics. Secondary study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS), the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).

Official Title
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Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study

Conditions
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Coronary Angioplasty

Intervention / Treatment
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* Other: Music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient needs a coronary angiography Patient gives verbal consent to participation in the study. Exclusion Criteria: Patient aged less than 18 years at time of enrollment Patient doesn't like music for cultural reason Patient with serious psychiatric disorders Patient with not paired deafness or paired one with devices that are incompatible with wearing a headset.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner: Control or music intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will undergo coronary angiography without music intervention. | |
| Experimental: Music therapy<br>The intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end. | Other: Music therapy<br>* The intervention group will administer U sequence between 10 minutes prior to the beginning of the procedure until its end.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Use of Midazolam Medication (mg) | The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg. | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. | 
| Dose Use of Propofol Medication (mg) | The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg. | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. | 
| Dose Use of Sufentanil Medication (ug) | The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug. | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room. | From 0 up to 45 minutes. | 
| Anxiety Score (NRS) | Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room. | From 0 up to 45 minutes. | 
| Satisfaction of the Patient | Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction. | Right after the end of the procedure in the recovery room. | 
| Effect on Physiological Parameters: BIS | Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure. The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is. | 10 minutes prior to the beginning of the procedure | 
| Effect on Physiological Parameters: Heart Rate | Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure. | 10 minutes prior to the beginning of the procedure. | 
| Effect on Physiological Parameters: SpO2% | SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure.. | 10 minutes prior to the beginning of the procedure. | 
| Effect on Physiological Parameters: Mean Arterial Blood Pressure | Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure. | 10 minutes prior to the beginning of the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music therapy, sedation, coronary angioplasty