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Completed

NCT Number: NCT03817775

Effect of Music on the Sedative Use During Coronary Angioplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end.

Primary outcomes

  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 was reported during the coronary angioplasty. Dose was 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 was reported during the coronary angioplasty. Dose was 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 was reported during the coronary angioplasty. Dose was in ug.

Secondary outcomes

  1. Pain Score

    Time frame: 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.

  2. Anxiety Score (NRS)

    Time frame: 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.

  3. Satisfaction of the Patient

    Time frame: 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.

  4. Effect on Physiological Parameters: BIS

    Time frame: 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.

  5. Effect on Physiological Parameters: Heart Rate

    Time frame: 10 minutes prior to the beginning of the procedure.

    Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.

  6. Effect on Physiological Parameters: SpO2%

    Time frame: 10 minutes prior to the beginning of the procedure.

    SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..

  7. Effect on Physiological Parameters: Mean Arterial Blood Pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Association de Musicothérapie Applications et Recherches Cliniques

Other

Collaborators

  • American Hospital of Paris

Registry information

Official study title

Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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