Trial Outcomes & Findings for Effect of Music on the Sedative Use During Coronary Angioplasty (NCT NCT03817775)
NCT ID: NCT03817775
Last Updated: 2019-10-21
Results Overview
The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.
COMPLETED
NA
76 participants
Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
2019-10-21
Participant Flow
Participant milestones
| Measure |
Control
The control group underwent coronary angiography without music intervention.
|
Music Therapy
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
54
|
|
Overall Study
COMPLETED
|
22
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=22 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 13.37 • n=22 Participants
|
67.2 years
STANDARD_DEVIATION 9.07 • n=54 Participants
|
65.7 years
STANDARD_DEVIATION 10.68 • n=76 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=22 Participants
|
6 Participants
n=54 Participants
|
10 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=22 Participants
|
48 Participants
n=54 Participants
|
66 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
22 participants
n=22 Participants
|
54 participants
n=54 Participants
|
76 participants
n=76 Participants
|
|
ASA Score
Normal: Score 1
|
2 Participants
n=22 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=76 Participants
|
|
ASA Score
Moderate abnormality: Score 2
|
3 Participants
n=22 Participants
|
5 Participants
n=54 Participants
|
8 Participants
n=76 Participants
|
|
ASA Score
Severe abnormality: Score 3
|
16 Participants
n=22 Participants
|
45 Participants
n=54 Participants
|
61 Participants
n=76 Participants
|
|
ASA Score
Missing
|
1 Participants
n=22 Participants
|
4 Participants
n=54 Participants
|
5 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=22 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Dose Use of Midazolam Medication (mg)
|
3.0 mg
Standard Deviation 0.84
|
1.2 mg
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.Population: One patient in control group and 2 patients in music therapy group had missing data on Propofol medication.
The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.
Outcome measures
| Measure |
Control
n=21 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=52 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Dose Use of Propofol Medication (mg)
|
12.8 mg
Standard Deviation 21.83
|
52 mg
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=22 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Dose Use of Sufentanil Medication (ug)
|
4.9 ug
Standard Deviation 1.21
|
5.1 ug
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: From 0 up to 45 minutes.Population: Three patients in control group and 3 patients in music therapy group had missing data on VAS 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.
Outcome measures
| Measure |
Control
n=19 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=51 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Pain Score
|
0.5 score on a scale
Standard Deviation 0.70
|
0.7 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=21 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=53 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Anxiety Score (NRS)
|
4.2 score on a scale
Standard Deviation 1.89
|
2.9 score on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Right after the end of the procedure in the recovery room.Population: Two patients in control group and 3 patients in music therapy group had missing data on satisfaction endpoint.
Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.
Outcome measures
| Measure |
Control
n=20 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=51 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Satisfaction of the Patient
|
4.5 Score
Standard Deviation 0.51
|
4.8 Score
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 10 minutes prior to the beginning of the procedurePopulation: 2 missing data in control group
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.
Outcome measures
| Measure |
Control
n=20 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Effect on Physiological Parameters: BIS
|
96.9 Score
Standard Deviation 2.1
|
94.9 Score
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 10 minutes prior to the beginning of the procedure.Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Outcome measures
| Measure |
Control
n=22 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Effect on Physiological Parameters: Heart Rate
|
71.3 beat/min
Standard Deviation 13.1
|
65.5 beat/min
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 10 minutes prior to the beginning of the procedure.SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..
Outcome measures
| Measure |
Control
n=22 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=54 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Effect on Physiological Parameters: SpO2%
|
98.5 Percentage of O2 saturation in blood
Standard Deviation 1.4
|
98.9 Percentage of O2 saturation in blood
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 10 minutes prior to the beginning of the procedure.Population: Two patients in control group and 1 in music therapy had missing data.
Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Outcome measures
| Measure |
Control
n=20 Participants
The control group underwent coronary angiography without music intervention.
|
Music Therapy
n=53 Participants
The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.
Music therapy: The intervention group administered "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
|
|---|---|---|
|
Effect on Physiological Parameters: Mean Arterial Blood Pressure
|
104.7 mmHg
Standard Deviation 14.1
|
104.2 mmHg
Standard Deviation 17.2
|
Adverse Events
Control
Music Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Gilles BOCCARA
• Department of Anaesthesia and Intensive Care, American Hospital of Paris
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place