Effect of Music on the Sedative Use During Coronary Angioplasty

Association de Musicothérapie Applications et Recherches Cliniques

Status: Completed

Conditions: Coronary Angioplasty

Treatments: Other: Music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03817775

MusicSeda

Details and patient eligibility

About

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.

Full 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).

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will undergo coronary angiography without music intervention.

Music therapy

Experimental group

Description:

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.

Treatment:

Other: Music therapy