Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study
Phase: NA
Conditions: Coronary Angioplasty
Sponsor: Association de Musicothérapie Applications et Recherches Cliniques

 
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Effect of Music on the Reduction of the Sedative Dose 
During Coronary Angioplasty: A Control-case 
Comparison Clinical Study  
MusicSeda 
 
 
STUDY PROTOCOL 
 
Version n°1.0 dated of 10/10/2018 
 
 
 
 
Administrator: 
American Hospital of Paris 
63 boulevard Victor Hugo  
92200 Neuilly-sur-Seine  
France 
 
Research responsible: 
Dr Gilles Boccara 
Department of Anaesthesia and Intensive Care 
American Hospital of Paris 
63 boulevard Victor Hugo  
92200 Neuilly-sur-Seine  
France  
Tel.: 01 46 41 25 25 
Email: gilles.boccara@ahparis.org 
 
 
 
 
 
 
 
 

 
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SIGNATURE PAGE OF THE PROTOCOL 
 
« Effect of Music on the Reduction of the Sedative Dose During Coronary 
Angioplasty: A Control-case Comparison Clinical Study » 
MusicSeda  
 
Version n°1.0 dated of 10/10/2018 
 
 
 
 
 
Research responsible: 
Dr Gilles Boccara 
Department of Anaesthesia and Intensive Care 
American Hospital of Paris 
63 boulevard Victor Hugo  
92200 Neuilly-sur-Seine  
France  
Tel.: 01 46 41 25 25 
Email: gilles.boccara@ahparis.org 
 
 
From Paris 
Date: 10/10/2018 
 
 
 
 
 
 
 
        Dr Gilles Boccara 
 
 
Signature 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
 
SIGNATURE PAGE OF THE PROTOCOL 
2 
1. 
PROTOCOL SYNOPSIS 
4 
2. 
SCIENTIFIC JUSTIFICATION 
6 
2.1. 
CURRENT STATE OF KNOWLEDGE 
6 
2.2. 
RESEARCH HYPOTHESES 
6 
3. 
OBJECTIVES 
7 
3.1. 
PRIMARY OBJECTIVE 
7 
3.2. 
SECONDARY OBJECTIVES 
7 
4. 
STUDY DESIGN 
7 
5. 
ELIGIBILITY CRITERIA 
8 
5.1. 
INCLUSION CRITERIA 
8 
5.2. 
NON-INCLUSION CRITERIA 
8 
5.3. 
PATIENT RECRUITMENT 
8 
6. 
NATURE OF ROUTINE CARE ASSESSED IN THE RESEARCH 
8 
7. 
EVALUATION CRITERIA 
9 
7.1. 
PRIMARY ENDPOINT 
9 
7.2. 
SECONDARY ENDPOINTS 
9 
8. 
GESTION OF SERIOUS ADVERSE EVENTS 
10 
9. 
STATISTICAL ASPECTS 
10 
9.1. 
SAMPLE SIZE CALCULATION 
10 
9.2. 
STATISTICAL METHODS 
10 
10. 
SOURCE DATA AND DOCUMENTS ACCESS RIGHTS 
10 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS 
11 
12. 
REFERENCES 
11 
 
 

 
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1. PROTOCOL SYNOPSIS 
ADMINISTRATOR 
American Hospital of Paris 
RESEARCH RESPONSIBLE 
Gilles Boccara 
Department of Anaesthesia and Intensive Care 
American Hospital of Paris 
TITLE 
Effect of Music on the Sedative Use During Coronary Angioplasty 
VERSION  
1.0 
JUSTIFICATION / CONTEXT 
Music therapy has been validated in the management of chronic pain 
and anxiety disorders. A program of music therapy will be proposed by 
the American Hospital of Paris. The objective of this study is to evaluate 
the effect of the music on the sedative use during coronary angioplasty. 
OBJECTIVES 
Principal objective  
To evaluate the effect of music therapy on the use of sedative 
medication during the intervention. 
 
Secondary objectives   
To evaluate the effect of music therapy on anxiety and pain scores. 
To evaluate the effect of music therapy on physiological parameters. 
To evaluation patient’s satisfaction.  
STUDY DESIGN 
Non-blinded, non-randomized controlled pilot study with no follow-up 
visit. It is composed of two group of patients: control group without 
music intervention and music group. The study will measure and 
compare sedative medication used during the coronary angioplasty 
procedure.  
INCLUSION CRITERIA 
- Patients aged >= 18 years 
- Patient needs a coronary angiography and/or angioplasty 
- Patient gives verbal consent to participation in the study  
EXCLUSION CRITERIA 
- Patient aged less than 18 years at time of enrolment 
- Patient who do not agree music for cultural and/or personal reasons 
- Patient with serious psychiatric disorders 
- Patient with not paired deafness or paired one with devices that are 
incompatible with wearing a headset.  
MUSIC SESSION  
Music therapy will be administered through a hardware and software 
provided to the investigative team by the Music-Care Company. The 
music intervention will be administered via a smartphone- (and 
computer-) based application called Music Care.  
EVALUATION CRITERIA 
Primary evaluation criterion  
Use of sedative medications (consumptions in intravenous midazolam 
and/or propofol required to reach sedation score 1 from 4 and/or BIS 
range of 80-90) during the procedure. 
 
Secondary evaluation criteria   
1) Pain and anxiety scores using the Numeric Rating Scale (NRS), 
the Visual Analog Scale (VAS) and the Amsterdam Preoperative 
Anxiety and Information Scale (APAIS). 

 
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2) Physiological parameters: BIS, heart rate, systolic, diastolic and 
mean arterial blood pressure, oxygen saturation. 
3) Satisfaction of the patient 
PLANNED SAMPLE SIZE 
100 patients 
PLANNED CENTERS 
1 centre: American Hospital of Paris 
DURATION OF THE RESEARCH 
- Duration of inclusion period: 2 months 
- Duration of patient participation: procedure duration (around 45 
minutes) 
- Total duration of the study: 2 months 
STATISTICAL ANALYSIS 
Analysis of the primary endpoint  
Comparison of consumption of medication (dose) will be performed 
using Student t-test or Wilcoxon rank sum test (non-parametric form of 
student t-tests, if distribution is not normal).  
  
Analysis of secondary endpoints  
Secondary endpoints as quantitative variables will be analysed using 
Student t-test or Wilcoxon rank sum test (non-parametric form of 
student t-tests, if distribution is not normal). No statistical test was 
performed on physiological parameters. 
EXPECTED RESULTS 
To propose a new therapeutic and non-drug approach in patients 
undergoing coronary angiography. 
To improve the relationship between medical team and patients. 
To reduce the treatment consumption. 
 
 
 
 

 
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2. SCIENTIFIC JUSTIFICATION  
Anxiety, stress and pain have always been sources of emotional distress for patients undergoing invasive 
procedures in clinical settings. 
Drug approaches such as analgesics and anxiolytics use are used to address these issues. But, with regards 
to new recommendations from Health Authorities, the use of pharmacological products tends to be 
reduced. Alternative and non-drug interventions, including music therapy, are then investigated in the 
next couple of years. These interventions may have the ability to reduce pain and anxiety while increasing 
relaxation during the procedure.  
Coronary angiography is one of these procedures in which patients tend to present stress and anxiety. 1 
Music therapy is a recent discipline with a trend of development in hospital services and in specialised 
ambulatory care centres. Several controlled studies allowed to validate the utilisation of music therapy in 
chronic or sharp pain, as well as in anxio-depressive disease. In this domain, the work of Stephane Guetin, 
psychologist and music therapist, helped using Music Care software to elaborate a standardised 
computerised method allowing its use by caregivers and patients themselves. 2, 3 
 
Researches on music therapy effect on invasive medical procedures are few.  
 
The demonstrated effects of music therapy on chronic pain and anxio-depressive disease allow to assume 
a benefic effect of this technique in the coronary angiography.  
Scientific data of music therapy on patients undergoing invasive procedure are positive and suppose its 
interest in this indication, but additional and more specific studies are needed to evaluate its indication on 
this specific procedure.  
The standardised and validated music therapy technique named as Music care seems to be a useful tool in 
standard cares and clinical research.  
2.1. CURRENT STATE OF KNOWLEDGE 
Recent clinical and neurophysiological studies made it possible to highlight the positive effect of music 
therapy in pain treatment 4. By shifting the attention, music decreases muscular tension and reduces 
anxiety. In pre and postoperative pains, patients under music decreased their drug consumption up to 
30%. 
The effects of music therapy are generally related to the fact that the individualized music broadcasting 
improves interactive components of pain. The impact of music therapy might be due to neurophysiologic 
effects, specific to pain, and to the music effect on sensory (attenuation of the conduction of afferent 
fibres), cognitive (memory encoding, diverts attention), affective (stimulates the production of 
endorphins) and behavioural (psychomotricity, muscular hypertonia) components. The effect of the music 
therapy is based on the impact of music on the components of the painful experience and the 
modification of pain perception.  
Psychological factors can interfere in the reduction of chronic painful phenomenon: music is chosen by the 
patient with his personal preferences, it allows to respond to an individual listening request. Listening to 
the patient after the music session allows him to evacuate their tensions.  
A single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, 
as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention 
period in intubated patients during weaning phase. 5 
2.2. RESEARCH HYPOTHESES  
The study is based on the hypothesis of an effect of music therapy during invasive procedures using its 
action on the 4 components: sensory, affective, behavioural and cognitive. 

 
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3. OBJECTIVES 
3.1. PRIMARY OBJECTIVE  
To evaluate the effect of music therapy on the use of sedative medication during the intervention. 
3.2. SECONDARY OBJECTIVES 
- 
To evaluate the effect of music therapy on anxiety and pain scores. 
- 
To evaluate the effect of music therapy on physiological parameters. 
- 
To evaluation patient’s satisfaction.  
4. STUDY DESIGN 
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 enrol 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, using intravenous sufentanil and midazolam titration to reach 
Bispectral index (BIS) score below 90 and sedation score ≤ 1. 
 
- Entry in the study: Verbal consent to participation in the study will be obtained from each patient prior 
to enrollment. Before their inclusion in the study, patients will be verbally given details about the methods 
and techniques of the music session. They will be given the choice to opt out of the music session if they 
desired to undergo the procedure without. 
 
- Inclusion: the following data will be collected: demographic and baseline characteristics, anxiety before 
the procedure using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 
 
- Music therapy session implementation 
The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the 
procedure until its end. 
 
- Evaluation during the procedure: the following data will be collected:  
• 
consumptions in analgesics, anxiolytics and hypnotics from 10 minutes prior to the procedure until 
its end 
• 
physiological parameters, such as BIS, heart rate, systolic, diastolic and mean arterial blood 
pressure, oxygen saturation at different time points between T0 (10 minutes prior to the 
beginning of the procedure) and T45 (45 minutes after it).  
 
- Final evaluation at the end of the procedure: the following data will be collected right after the end of 
the procedure in the recovery room: 
• 
pain and anxiety scores as measured the Numeric Rating Scale (NRS)  
• 
satisfaction was also collected using a scale from 0 to 5, with a higher score for a high satisfaction. 

 
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5. ELIGIBILITY CRITERIA 
5.1. INCLUSION CRITERIA 
- Patients aged of at least 18 years 
- Patients who need a coronary angiopathy and/or angioplasty 
- Patients who give his informed consent. 
5.2. NON-INCLUSION CRITERIA 
- Patients aged less than 18 years 
- Patient who do not agree music for cultural and/or personal reasons 
- Patients with serious psychiatric disorder 
- Patients with not paired deafness or paired one with devices that were incompatible with wearing a 
headset  
5.3. PATIENT RECRUITMENT 
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 nonrandomized manner: Control or music intervention. 
Inclusion and exclusion criteria will be checked by the responsible of the study during the inclusion visit.  
This study will enrol around 100 patients. 
6. NATURE OF ROUTINE CARE ASSESSED IN THE RESEARCH  
The Music Care app is a receptive music intervention, allowing the patient to choose the preferred style 
between different sequences of instrumental music. All musical pieces were recorded in high-quality 
recording studios with professional musicians.  
Music Care utilizes the “U” technique (Figure 1), designed to gradually relax the listener. In the current 
study, music sequences during patients’ sessions were based on the mount “U”, and instrumental musical 
works were selected for a varying numbers styles (classical, jazz, world music, etc.) and adapted to the 
patient's style via patient request. The “U” technique is implemented using a musical sequence of 20 
minutes that was divided into 5 different musical pieces at 3 to 4 minutes each. Initially, the objective is to 
represent the patient's state of tension by stimulating musical rhythm (80-95 beats per minute (bpm). 
From there, the remaining 4 sub-pieces are presented in a blended fashion in an attempt for the patient to 
gradually fall into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, 
frequencies, and volume (descending arm of the “U”). The music session then reaches a phase of 
maximum relaxation (downward phase of the "U”) before a phase that gradually returns to baseline 
dynamics (ascending arm of the “U”).  

 
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Figure 1: The “U” sequence 
 
 
The training to Music care software for the doctors in charge of the study will be done by a music therapist 
from AM-ARC, with a validated diploma and experience in clinical research.  
7. EVALUATION CRITERIA 
7.1. PRIMARY ENDPOINT 
Use of sedative medications. 
 
The studied variable will be the consumptions in intravenous midazolam and/or propofol required to 
reach sedation score 1 from 4 and/or BIS range of 80-90 during the coronary angioplasty and/or 
angioplasty.  
7.2. SECONDARY ENDPOINTS 
- 
Pain and anxiety scores. 
Pain and anxiety scores will be measured using the Numeric Rating Scale (NRS), the Visual Analog Scale 
(VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be completed right 
after the end of the procedure in the recovery room. 
 
- 
Effect on physiological parameters. 
The following physiological parameters will be measured: BIS, heart rate, systolic, diastolic and mean 
arterial blood pressure, oxygen saturation between 10 minutes prior to the beginning of the procedure 
until 45 minutes after it. 
 
- 
Satisfaction of the patient 
Satisfaction will be measured using a scale from 0 to 5, with a higher score for a high satisfaction. 
 

 
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8. GESTION OF SERIOUS ADVERSE EVENTS 
No procedure for serious adverse events is imposed by the research. Nevertheless, declaration of serious 
adverse events to the regional center of pharmacovigilance is mandatory for all doctor and health 
professional. 
9. STATISTICAL ASPECTS 
9.1. SAMPLE SIZE CALCULATION 
As this is a pilot study, no formal sample size calculation has been performed. However, the number of 
participants necessary was estimated at 100 in order to get a sufficient power. Since there was no follow-
up, increasing the sample size was not necessary to mitigate for missing data. 
9.2. STATISTICAL METHODS 
Baseline characteristics 
Baseline characteristics will be summarized. Qualitative variables will be described using number of 
patients, percentage. Quantitative variables will be described as number of patients, mean, standard 
deviation, confidence interval of the mean, median, Q1, Q3, minimum and maximum.  
 
Analysis of primary endpoint  
Comparison of consumption of medication (dose) will be performed using Student t-test or Wilcoxon rank 
sum test (non-parametric form of student t-tests, if distribution is not normal). The analysis will be 
performed in intent-to-treat. 
 
Analysis of secondary endpoints 
Secondary endpoints as quantitative variables will be analyzed using Student t-test or Wilcoxon rank sum 
test (non-parametric form of student t-tests, if distribution is not normal). No statistical test was 
performed on physiological parameters. 
 
All the tests will be realized using BiostaTGV website with α =5%. A statistical analysis plan will be 
prepared and will detailed the different analyses.  
10. SOURCE DATA AND DOCUMENTS ACCESS RIGHTS  
The administrator is in charge to obtain the agreement of all the parties implicated in the research in 
order to guarantee direct access to source data, reports and documents everywhere the study is 
conducted in case of quality control and audit. 
Source data or document is defined as any original document which allow to demonstrate the existence, 
or the accuracy of a data collected during the research. 
The data will be entered in Excel. They will be managed by the investigator and stored on the computer 
server of the American Hospital of Paris, which will safeguard them.  

 
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11. ETHICAL AND REGULATORY CONSIDERATIONS 
Since the techniques and methods used in this research are usually carried out, it can be used as part of 
research to evaluate routine care as defined by Law No. 2004-806 of 9 August 2004 (Article L1121-1, 
paragraph 2 and Article R1121-3 of the Public Health Code). 
 
The administrator and the person(s) who directs and supervises the research undertake that this research 
will be carried out in accordance with Law No. 2004-806 of 9 August 2004, as well as in accordance with 
Good Clinical Practice (I.C.H. version 4 of 1 May 1996) and the Helsinki Declaration (which can be found in 
its full version on the website http://www.wma.net/en/30publications/10policies/b3/).  
 
The research shall be conducted in accordance with this Protocol. Except in emergency situations 
requiring specific therapeutic procedures, the person(s) who directs and monitors the research 
undertakes to comply with the protocol in every respect. 
 
This research received the favorable opinion of the Institutional Reviewer Board of the American Hospital 
of Paris. 
12. REFERENCES 
1. Bally K1, Campbell D, Chesnick K, Tranmer JE. Effects of patient-controlled music therapy 
during coronary angiography on procedural pain and anxiety distress syndrome. Crit Care 
Nurse. 2003 Apr;23(2):50-8. 
 
2. Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre 
E, The effects of music intervention in the management of chronic pain: a single-blind, 
randomized, controlled trial.” Touchon J. Clinical Journal of Pain. 2012 May;28(4):329-37. 
 
3. Guétin 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. 
 
4. Aderson J., Music and pattern change in chronic pain. Adv. Nurs. Sci., 1993, 15; 27-36. 
 
5. Jaber S, Bahloul H, Guétin 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. Epub 2006 Nov 3. French.