Effect of Music on the Sedative Use During Coronary Angioplasty

Not Applicable

Completed

Conditions: Coronary Angioplasty

Interventions: Other: Music therapy

Registration Number: NCT03817775

Lead Sponsor: Association de Musicothérapie Applications et Recherches Cliniques

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy	Music therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain Score	From 0 up to 45 minutes.	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.
Effect on Physiological Parameters: BIS	10 minutes prior to the beginning of the procedure	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.
Anxiety Score (NRS)	From 0 up to 45 minutes.	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.
Satisfaction of the Patient	Right after the end of the procedure in the recovery room.	Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.
Effect on Physiological Parameters: SpO2%	10 minutes prior to the beginning of the procedure.	SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..
Effect on Physiological Parameters: Mean Arterial Blood Pressure	10 minutes prior to the beginning of the procedure.	Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Effect on Physiological Parameters: Heart Rate	10 minutes prior to the beginning of the procedure.	Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.