Coronary Angioplasty
Conditions
Keywords
Music therapy, sedation, coronary angioplasty
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).
Interventions
OTHERMusic therapy
The intervention group will administer U sequence between 10 minutes prior to the beginning of the procedure until its end.
Sponsors
American Hospital of Paris
Association de Musicothérapie Applications et Recherches Cliniques
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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: 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: SpO2% | 10 minutes prior to the beginning of the procedure. | SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure.. |
| 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control group underwent coronary angiography without music intervention. | 22 |
| 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. | 54 |
| Total | 76 |
Baseline characteristics
| Characteristic | Control | Music Therapy | Total |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 13.37 | 67.2 years STANDARD_DEVIATION 9.07 | 65.7 years STANDARD_DEVIATION 10.68 |
| ASA Score Missing | 1 Participants | 4 Participants | 5 Participants |
| ASA Score Moderate abnormality: Score 2 | 3 Participants | 5 Participants | 8 Participants |
| ASA Score Normal: Score 1 | 2 Participants | 0 Participants | 2 Participants |
| ASA Score Severe abnormality: Score 3 | 16 Participants | 45 Participants | 61 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 22 participants | 54 participants | 76 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 48 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 54 |
| other Total, other adverse events | 0 / 22 | 0 / 54 |
| serious Total, serious adverse events | 0 / 22 | 0 / 54 |
Outcome results
Primary
Dose Use of Midazolam Medication (mg)
The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.
Time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Dose Use of Midazolam Medication (mg) | 3.0 mg | Standard Deviation 0.84 |
| Music Therapy | Dose Use of Midazolam Medication (mg) | 1.2 mg | Standard Deviation 0.76 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Dose Use of Propofol Medication (mg)
The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Dose Use of Propofol Medication (mg) | 12.8 mg | Standard Deviation 21.83 |
| Music Therapy | Dose Use of Propofol Medication (mg) | 52 mg | Standard Deviation 0 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Primary
Dose Use of Sufentanil Medication (ug)
The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.
Time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Dose Use of Sufentanil Medication (ug) | 4.9 ug | Standard Deviation 1.21 |
| Music Therapy | Dose Use of Sufentanil Medication (ug) | 5.1 ug | Standard Deviation 1.02 |
p-value: 0.7215Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: From 0 up to 45 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Anxiety Score (NRS) | 4.2 score on a scale | Standard Deviation 1.89 |
| Music Therapy | Anxiety Score (NRS) | 2.9 score on a scale | Standard Deviation 2.19 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 10 minutes prior to the beginning of the procedure
Population: 2 missing data in control group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Effect on Physiological Parameters: BIS | 96.9 Score | Standard Deviation 2.1 |
| Music Therapy | Effect on Physiological Parameters: BIS | 94.9 Score | Standard Deviation 5.5 |
Secondary
Effect on Physiological Parameters: Heart Rate
Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.
Time frame: 10 minutes prior to the beginning of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Effect on Physiological Parameters: Heart Rate | 71.3 beat/min | Standard Deviation 13.1 |
| Music Therapy | Effect on Physiological Parameters: Heart Rate | 65.5 beat/min | Standard Deviation 11.4 |
Secondary
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.
Time frame: 10 minutes prior to the beginning of the procedure.
Population: Two patients in control group and 1 in music therapy had missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Effect on Physiological Parameters: Mean Arterial Blood Pressure | 104.7 mmHg | Standard Deviation 14.1 |
| Music Therapy | Effect on Physiological Parameters: Mean Arterial Blood Pressure | 104.2 mmHg | Standard Deviation 17.2 |
Secondary
Effect on Physiological Parameters: SpO2%
SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..
Time frame: 10 minutes prior to the beginning of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Effect on Physiological Parameters: SpO2% | 98.5 Percentage of O2 saturation in blood | Standard Deviation 1.4 |
| Music Therapy | Effect on Physiological Parameters: SpO2% | 98.9 Percentage of O2 saturation in blood | Standard Deviation 1.3 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain Score | 0.5 score on a scale | Standard Deviation 0.7 |
| Music Therapy | Pain Score | 0.7 score on a scale | Standard Deviation 1.47 |
p-value: 0.5675Wilcoxon (Mann-Whitney)
Secondary
Satisfaction of the Patient
Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Satisfaction of the Patient | 4.5 Score | Standard Deviation 0.51 |
| Music Therapy | Satisfaction of the Patient | 4.8 Score | Standard Deviation 0.44 |