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| Name | Class |
|---|---|
| American Hospital of Paris | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will undergo coronary angiography without music intervention. | |
| Music therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy | Other | The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles BOCCARA, PhD | Department of Anaesthesia and Intensive Care, American Hospital of Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Hospital of Paris | Neuilly-sur-Seine | 92200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17085009 | Background | 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. | |
| 22001666 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control group underwent coronary angiography without music intervention. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group underwent coronary angiography without music intervention. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Use of Midazolam Medication (mg) | The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg. | Posted | Mean | Standard Deviation | mg | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. |
|
From 0 up to 45 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group underwent coronary angiography without music intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gilles BOCCARA | • Department of Anaesthesia and Intensive Care, American Hospital of Paris | +33 1 46 41 25 25 | gilles.boccara@ahparis.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2018 | Jun 27, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2018 | Jun 27, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.
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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. |
| 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. |
| 27618935 | Background | 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. |
| 27548494 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA Score | Count of Participants | Participants |
|
|
|
|
| Primary | Dose Use of Propofol Medication (mg) | The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg. | One patient in control group and 2 patients in music therapy group had missing data on Propofol medication. | Posted | Mean | Standard Deviation | mg | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. |
|
|
|
|
| Primary | Dose Use of Sufentanil Medication (ug) | The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug. | Posted | Mean | Standard Deviation | ug | Between 10 minutes prior to the beginning of the procedure up to 45 minutes. |
|
|
|
|
| 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. | Three patients in control group and 3 patients in music therapy group had missing data on VAS pain score. | Posted | Mean | Standard Deviation | score on a scale | From 0 up to 45 minutes. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | From 0 up to 45 minutes. |
|
|
|
|
| Secondary | Satisfaction of the Patient | Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction. | Two patients in control group and 3 patients in music therapy group had missing data on satisfaction endpoint. | Posted | Mean | Standard Deviation | Score | Right after the end of the procedure in the recovery room. |
|
|
|
| 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. | 2 missing data in control group | Posted | Mean | Standard Deviation | Score | 10 minutes prior to the beginning of the procedure |
|
|
|
| Secondary | Effect on Physiological Parameters: Heart Rate | Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure. | Posted | Mean | Standard Deviation | beat/min | 10 minutes prior to the beginning of the procedure. |
|
|
|
| Secondary | Effect on Physiological Parameters: SpO2% | SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure.. | Posted | Mean | Standard Deviation | Percentage of O2 saturation in blood | 10 minutes prior to the beginning of the procedure. |
|
|
|
| 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. | Two patients in control group and 1 in music therapy had missing data. | Posted | Mean | Standard Deviation | mmHg | 10 minutes prior to the beginning of the procedure. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Severe abnormality: Score 3 |
|
| Missing |
|