Music Medicine in Coronary Interventional Cardiology Procedures

Condition(s) studied

Investigational drug(s) / intervention(s)

Music Medicine intervention: The 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.

Study summary

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

Eligibility

Primary outcome measure(s)

• Mean Change From Baseline in State Anxiety Score Assessed by the State-Trait Anxiety Inventory (STAI-Y1) — At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes
  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.

Trial sites (1)

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