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Effect of Music on the Sedative Use During Coronary Angioplasty

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ClinicalTrials.gov Identifier: NCT03817775
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
American Hospital of Paris
Information provided by (Responsible Party):
Association de Musicothérapie Applications et Recherches Cliniques

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.

Condition or disease Intervention/treatment Phase
Coronary Angioplasty Other: Music therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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.




Primary Outcome Measures :
  1. Dose use of Midazolam medication (mg) [ Time Frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes. ]
    The consumption in Midazolam medication will be reported during the coronary angioplasty. Dose will be in mg.

  2. Dose use of Propofol medication (mg) [ Time Frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes. ]
    The consumption in Propofol medication will be reported during the coronary angioplasty. Dose will be in mg.

  3. Dose use of Sufentanil medication (ug) [ Time Frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes. ]
    The consumption in Sufentanil medication will be reported during the coronary angioplasty. Dose will be in ug.


Secondary Outcome Measures :
  1. Pain score [ Time Frame: From 0 up to 45 minutes. ]
    Pain score will be measured using the Visual Analog Scale (VAS). This scale ranges from 0 (no pain) to 10 (very high pain), and will collect the maximum pain the patient had during the procedure. This will be collected right after the end of the procedure in the recovery room.

  2. Anxiety score (NRS) [ Time Frame: From 0 up to 45 minutes. ]
    Anxiety score will be measured using the Numeric Rating Scale (NRS). This scale ranges from 0 (no anxiety) to 10 (very high anxiety), and will collect the maximum anxiety the patient had during the procedure. This will be collected right after the end of the procedure in the recovery room.

  3. Effect on physiological parameters: blood pressure [ Time Frame: Between 10 minutes prior to the beginning of the procedure until 45 minutes after it. ]
    The following parameters will be measured: systolic, diastolic and mean arterial blood pressure in mmHg. Time points will be T0, T5, P (artery puncture), T15, T30 and T45 (minutes).

  4. Effect on physiological parameters: BIS [ Time Frame: Between 10 minutes prior to the beginning of the procedure until 45 minutes after it. ]
    The following parameters will be measured: Bispectral index (BIS). It ranges from 0 (equivalent to EEG silence) to 100. Time points will be T0, T5, P (artery puncture), T15, T30 and T45 (minutes).

  5. Effect on physiological parameters: Heart rate [ Time Frame: Between 10 minutes prior to the beginning of the procedure until 45 minutes after it. ]
    The following physiological parameters will be measured: heart rate in beats per minute (BPM). Time points will be T0, T5, P (artery puncture), T15, T30 and T45 (minutes).

  6. Effect on physiological parameters: SpO2% [ Time Frame: Between 10 minutes prior to the beginning of the procedure until 45 minutes after it. ]
    The following physiological parameters will be measured: oxygen saturation (SpO2) in %. Time points will be T0, T5, P (artery puncture), T15, T30 and T45 (minutes).

  7. Satisfaction of the patient [ Time Frame: Right after the end of the procedure in the recovery room. ]
    Satisfaction will be measured using a scale from 0 to 5, with a higher score for a high satisfaction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817775


Locations
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France
American Hospital of Paris
Neuilly-sur-Seine, France, 92200
Sponsors and Collaborators
Association de Musicothérapie Applications et Recherches Cliniques
American Hospital of Paris
Investigators
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Principal Investigator: Gilles BOCCARA, PhD Department of Anaesthesia and Intensive Care, American Hospital of Paris

Publications:
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Responsible Party: Association de Musicothérapie Applications et Recherches Cliniques
ClinicalTrials.gov Identifier: NCT03817775     History of Changes
Other Study ID Numbers: MusicSeda
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Association de Musicothérapie Applications et Recherches Cliniques:
Music therapy
sedation
coronary angioplasty

Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs