Effect of Music on the Sedative Use During Coronary Angioplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Angioplasty
• Intervention / Treatment: Other: Music therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Seine, France, 92200
    • American Hospital of Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will undergo coronary angiography without music intervention.
Experimental: 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.	Other: Music therapy; The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Association de Musicothérapie Applications et Recherches Cliniques
• Collaborators: American Hospital of Paris
• Investigators: Principal Investigator: Gilles BOCCARA, PhD, Department of Anaesthesia and Intensive Care, American Hospital of Paris

Publications and helpful links

General Publications

• Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
• Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
• Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
• Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: sedation; Music therapy; coronary angioplasty
• Other Study ID Numbers: MusicSeda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No