Effect of Music on the Sedative Use During Coronary Angioplasty

Coronary Angioplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817775
• Other study ID #: MusicSeda
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: April 3, 2019

Study information

• Verified date: October 2019
• Source: Association de Musicothérapie Applications et Recherches Cliniques
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Angioplasty

Intervention

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

Locations

Country	Name	City	State
France	American Hospital of Paris	Neuilly-sur-Seine

Sponsors (2)

Lead Sponsor	Collaborator
Association de Musicothérapie Applications et Recherches Cliniques	American Hospital of Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Guétin 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. — View Citation

Guétin S, Giniès P, Siou DK, Picot MC, Pommié 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. — View Citation

Jaber S, Bahloul H, Guétin 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. Epub 2006 Nov 3. French. — View Citation

Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guétin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
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.	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.	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.	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.	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.	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..	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.	10 minutes prior to the beginning of the procedure.