The purpose of the study is: to evaluate the effectiveness of a personalized Music Medicine intervention in patients undergoing invasive coronary interventional cardiology procedures. The study will compare patients who listen to a personalized music playlist through wireless earphones throughout the procedure with patients receiving standard care without music. The primary objective is to assess whether Music Medicine reduces state anxiety, measured using the State-Trait Anxiety Inventory (STAI-Y1). Secondary objectives are to evaluate its effects on access-site crossover, procedural pain, blood pressure, heart rate, and oxygen saturation. The study will also assess adverse reactions, withdrawals, patient satisfaction with the intervention, and, in the Music Medicine group, patients' perceived experience through a semi-structured qualitative interview. The study is designed as a prospective, single-center, open-label, randomized controlled trial with two parallel groups and a 1:1 allocation ratio, enrolling 208 participants.
The question the study is trying to answer is: whether listening to a personalized music playlist during an invasive coronary interventional cardiology procedure, in addition to standard care, reduces state anxiety compared with standard care alone, and whether it also improves other relevant procedural outcomes, including pain, the need for access-site crossover, blood pressure, heart rate, and oxygen saturation, without interfering with routine clinical care
age >18 years;
provision of written informed consent and ability to understand the informed consent form.
patients with ST-segment elevation myocardial infarction (STEMI);
patients with very-high-risk non-ST-segment elevation myocardial infarction (NSTEMI), as classified according to the 2023 European Society of Cardiology (ESC) Guidelines;
patients in cardiogenic shock;
presence of hearing impairment or deafness, assessed through clinical history;
Parallel
Music Medicine intervention
Other interventionThe patient will listen to selected music with characteristics associated with relaxation, calmness, and personal enjoyment, with the aim of reducing anxiety and pain. A healthcare professional will prepare the playlist in the sequence selected by the patient and password-protect it on an MP3 device connected to Spotify. The patient will listen to the playlist through wireless earphones throughout the coronary interventional cardiology procedure.
Mean Change From Baseline in State Anxiety Score Assessed by the State-Trait Anxiety Inventory (STAI-Y1)
State anxiety will be assessed using the State-Trait Anxiety Inventory, State subscale (STAI-Y1). The STAI-Y1 consists of 20 items rated on a 4-point Likert scale. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. The outcome will be expressed as the mean change in STAI-Y1 total score from baseline to immediately after the coronary interventional cardiology procedure.
Number of Participants Requiring Access-Site Crossover During the Coronary Interventional Cardiology Procedure
Access-site crossover is defined as the need to change from the initially selected arterial access site to another arterial access site during the coronary interventional cardiology procedure. The occurrence of crossover and the alternative arterial access site used will be recorded.
Mean Procedural Pain Score Assessed by the Visual Analog Scale (VAS)
Procedural pain will be assessed using the Visual Analog Scale (VAS), consisting of a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst possible pain"). Immediately after the procedure, participants will indicate the overall level of pain experienced throughout the entire coronary interventional cardiology procedure. Higher scores indicate greater pain.
Mean Change From Baseline in Heart Rate
Heart rate will be measured using a digital monitor and recorded in beats per minute. The outcome will be expressed as the mean change in heart rate from baseline to immediately after the coronary interventional cardiology procedure.
Number of Participants With Adverse Reactions
Adverse reactions occurring in study participants will be recorded at the post-procedure assessment. The number of participants experiencing an adverse reaction and the type of reaction will be documented.
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