Effects of Music Medicine in Patients Undergoing Coronary Interventional Cardiology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 208
- 主要终点
- Mean Change From Baseline in State Anxiety Score Assessed by the State-Trait Anxiety Inventory (STAI-Y1)
研究概览
简要总结
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
详细描述
Coronary interventional cardiology procedures include invasive percutaneous procedures such as coronary angiography and percutaneous coronary intervention. These procedures are performed in the cardiac catheterization laboratory and may last approximately 30 to 120 minutes, depending on the clinical situation and procedural complexity. Although they are routinely performed and are essential for the diagnosis and treatment of coronary artery disease, the procedural environment, arterial access, manipulation of catheters and guidewires, and uncertainty related to the intervention may be associated with anxiety, discomfort, and pain.
Procedure-related anxiety may have both psychological and physiological consequences. Activation of autonomic and neuroendocrine stress responses may influence cardiovascular parameters and may also increase the perception of procedural pain. Pain itself may have procedural implications. In particular, during transradial procedures, pain and discomfort may contribute to radial artery spasm, which can make catheter manipulation more difficult and, in some cases, require a change to another arterial access site.
Pharmacological strategies, including analgesic and sedative medications, may be used when clinically indicated to manage anxiety, discomfort, and pain during invasive cardiac procedures. However, complementary non-pharmacological approaches may provide additional support without replacing or modifying standard clinical treatment.
Music Medicine refers to the structured use of music within healthcare by trained healthcare professionals according to a defined protocol. In this study, Music Medicine is considered a complementary, patient-centered intervention intended to make the procedural experience more comfortable while preserving all aspects of routine medical and nursing care. Previous research in cardiovascular settings has suggested that music-based interventions may have beneficial effects on psychological distress, anxiety, pain, blood pressure, heart rate, and overall patient well-being. Music has also been studied during angiographic and cardiac catheterization procedures, but evidence concerning a fully personalized music intervention delivered throughout coronary interventional procedures remains limited.
MUSICOR is a prospective, single-center, open-label, randomized controlled study conducted at the Cardiac Catheterization Laboratory of the University Hospital of Sassari, Italy. A total of 208 participants undergoing invasive coronary interventional cardiology procedures will be enrolled and randomly allocated in a 1:1 ratio to either a Music Medicine group or a standard-care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years;
- •provision of written informed consent and ability to understand the informed consent form.
排除标准
- •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;
- •patients unable to express their musical preferences;
- •patients with resuscitated cardiac arrest;
- •use of antipsychotic medications, assessed through clinical history;
- •history of epilepsy, assessed through clinical history.
结局指标
主要结局
Mean Change From Baseline in State Anxiety Score Assessed by the State-Trait Anxiety Inventory (STAI-Y1)
时间窗: 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.
次要结局
- Number of Participants Requiring Access-Site Crossover During the Coronary Interventional Cardiology Procedure(During the coronary interventional cardiology procedure, up to 120 minutes)
- Mean Procedural Pain Score Assessed by the Visual Analog Scale (VAS)(immediately after the cardiology procedure, up to 120 minutes)
- Mean Change From Baseline in Heart Rate(At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes)
- Number of Participants With Adverse Reactions(Immediately after the cardiology procedure,up to 120 minutes)
- Number of Participants Who Withdraw From the Study(From enrollment through completion of the post-procedure assessment, up to 1 day)
- Mean Change From Baseline in Peripheral Oxygen Saturation (SpO2)(At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes)
- Mean Change From Baseline in Systolic Blood Pressure(At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes)
- Mean Change From Baseline in Diastolic Blood Pressure(At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes)
研究者
Valentina Micheluzzi
Principal Investigator
Azienda Ospedaliero Universitaria di Sassari