Effect of Music on the Sedative Use During Coronary Angioplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2019-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation

NCT06953752

Atrial Fibrillation (AF) Catheter Ablation Pain Management

RECRUITING NA

Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients

NCT05317910

Alzheimer Disease

COMPLETED NA

Effectiveness of Music Therapy on Sleep Disorders

NCT04578860

Sleep Disorder Chronic Insomnia

UNKNOWN NA

Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting

NCT05398419

Sleep Disturbance Insomnia Music Listening Intervention +1 more

UNKNOWN NA

Music in Interventional Radiology Procedures

NCT05728398

Patient Satisfaction

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Angioplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

The control group will undergo coronary angiography without music intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music therapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No