[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653518":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":42,"armGroups":50,"interventions":61,"overallOfficials":42,"centralContacts":68,"locations":74,"responsibleParty":90,"collaborators":42,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":42,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":118,"whyStopped":42,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Azienda Ospedaliero Universitaria di Sassari","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes",[14,18,22,25,29,33,36,39],{"measure":15,"description":16,"timeFrame":17},"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.","During the coronary interventional cardiology procedure, up to 120 minutes",{"measure":19,"description":20,"timeFrame":21},"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.","immediately after the cardiology procedure, up to 120 minutes",{"measure":23,"description":24,"timeFrame":12},"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.",{"measure":26,"description":27,"timeFrame":28},"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.","Immediately after the cardiology procedure,up to 120 minutes",{"measure":30,"description":31,"timeFrame":32},"Number of Participants Who Withdraw From the Study","The number of participants who withdraw from the study will be recorded. The reason for withdrawal, when available, will also be documented.","From enrollment through completion of the post-procedure assessment, up to 1 day",{"measure":34,"description":35,"timeFrame":12},"Mean Change From Baseline in Peripheral Oxygen Saturation (SpO2)","Peripheral oxygen saturation (SpO2) will be measured using a digital monitor and recorded as a percentage. The outcome will be expressed as the mean change in SpO2 from baseline to immediately after the coronary interventional cardiology procedure.",{"measure":37,"description":38,"timeFrame":12},"Mean Change From Baseline in Systolic Blood Pressure","ystolic blood pressure will be measured using a digital monitor and recorded in millimeters of mercury (mmHg). The outcome will be expressed as the mean change in systolic blood pressure from baseline to immediately after the coronary interventional cardiology procedure.",{"measure":40,"description":41,"timeFrame":12},"Mean Change From Baseline in Diastolic Blood Pressure","Diastolic blood pressure will be measured using a digital monitor and recorded in millimeters of mercury (mmHg). The outcome will be expressed as the mean change in diastolic blood pressure from baseline to immediately after the coronary interventional cardiology procedure.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE","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.\n\nProcedure-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.\n\nPharmacological 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.\n\nMusic 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.\n\nMUSICOR 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.\n\nParticipants will be recruited consecutively during hospitalization. After enrollment and completion of baseline study procedures, participants will be assigned to one of the two study groups using a computer-generated random allocation sequence. The randomization sequence will be prepared by a data manager who is not involved in participant recruitment or clinical management. Allocation will be implemented using sequentially numbered, opaque, sealed envelopes in order to prevent advance knowledge of group assignment. Because participants in the intervention group will listen to music and healthcare professionals must manage the music-delivery system, blinding of participants and clinical staff is not feasible.\n\n\\### Music Medicine Intervention\n\nParticipants assigned to the Music Medicine group will receive a personalized music intervention in addition to routine clinical care.\n\nBefore the coronary procedure, a healthcare professional trained in Music Medicine and in the research protocol will discuss the participant's musical preferences. Rather than prescribing a predetermined genre of music, the intervention is centered on the individual participant's preferences. Participants will be encouraged to select music that they personally associate with relaxation, calmness, reassurance, or enjoyment.\n\nThe participant may identify individual songs directly or may initially indicate preferred artists, genres, or types of music from which appropriate tracks can then be selected. The final choice of music will remain patient-centered. The participant will also be able to determine the sequence in which the selected tracks are played.\n\nA personalized playlist will then be prepared according to the participant's selections. Before the coronary procedure begins, trained healthcare personnel will verify the audio system, prepare the playlist, and position wireless earphones. Playback will begin before or at the start of the invasive procedure and will continue throughout the procedure according to the predefined sequence selected by the participant.\n\nThe audio system is designed so that the use of music does not prevent communication between the participant and the healthcare team. Medical and nursing staff will remain able to communicate with the participant during the procedure through the study communication system whenever clinically necessary. Participants will therefore remain in contact with the clinical team and able to communicate needs or discomfort during the intervention.\n\nThe music intervention will not determine or modify any diagnostic, interventional, pharmacological, or therapeutic decision. The arterial access site, procedural technique, use of medications, administration of analgesia or sedation, and any additional treatment will continue to be determined exclusively by the treating physicians according to the participant's clinical condition and routine clinical practice.\n\nThe Music Medicine intervention may be discontinued at any time if requested by the participant or if interruption is considered necessary for clinical or procedural reasons. At completion of the coronary procedure, the earphones will be removed and the disposable components of the system will be discarded and replaced before use with another participant.\n\n\\### Standard-Care Group\n\nParticipants assigned to the control group will undergo the coronary procedure according to the routine clinical and nursing care provided in the Cardiac Catheterization Laboratory of the University Hospital of Sassari.\n\nStandard care includes routine preparation for the procedure, continuous clinical monitoring, monitoring of vital signs, medical and nursing assistance throughout the procedure, and administration of pharmacological treatment, including analgesic and\u002For sedative medication when clinically indicated.\n\nThe arterial access site, procedural strategy, interventional techniques, and any additional treatment will be selected according to the participant's clinical condition, physician judgment, and current clinical practice.\n\nParticipants in the standard-care group will not wear study earphones and will not listen to either a personalized playlist or other music as part of the study during the coronary procedure. Apart from the Music Medicine intervention, clinical care will be comparable between the two study groups.\n\n\\### Study Assessments and Data Collection\n\nThe study includes a baseline assessment before the coronary procedure and a post-procedure assessment after completion of the intervention.\n\nAt baseline, sociodemographic and clinically relevant information will be recorded to characterize the study population. These data include demographic characteristics and selected cardiovascular and clinical variables, such as cardiovascular risk profile, current medical therapy, left ventricular function, body mass index, functional status, and comorbidity burden.\n\nStudy assessments will examine psychological, procedural, and physiological aspects of the participant's experience before and after the coronary procedure. The study will also document procedural information relevant to arterial access and any need to change the initially selected access site.\n\nAll study data will be entered into a dedicated electronic database using the REDCap platform.\n\n\\### Patient Experience Component\n\nIn addition to the quantitative comparison between the two randomized groups, MUSICOR includes a qualitative component intended to provide a more detailed understanding of how participants experience personalized music during an invasive coronary procedure.\n\nParticipants who receive the Music Medicine intervention will be asked about their satisfaction with the intervention. They will also take part in an individual semi-structured interview conducted after the coronary procedure, at a time compatible with their clinical condition.\n\nThe interview will be conducted by a psychologist using an open-ended and non-directive approach and will be audio-recorded for subsequent transcription and analysis. Participants will be encouraged to describe the experience in their own words.\n\nThe interview will explore several aspects of the intervention, including expectations before the procedure, the meaning attributed to listening to music, perceived emotional and physical effects, the importance of being able to personalize the playlist, comfort and acceptability of the earphones, communication with healthcare professionals while listening to music, perception of the catheterization laboratory environment and passage of time, and any positive, negative, or neutral aspects of the experience.\n\nParticipants will also be invited to describe whether they would choose to use personalized music again during a similar future procedure and to provide suggestions regarding music selection, playlist preparation, listening methods, or communication with clinical staff.\n\nThe qualitative component is intended to complement the quantitative findings by identifying aspects of acceptability, feasibility, and patient experience that may not be fully captured through standardized measurements.\n\n\\### Analysis\n\nQuantitative analyses will follow an intention-to-treat approach. Baseline characteristics of the study groups will be summarized using descriptive statistics, and the comparability of the randomized groups will be examined using appropriate statistical tests.\n\nFor repeatedly assessed continuous variables, the principal analysis will consider both treatment group and time, as well as the interaction between treatment group and time, in order to determine whether changes occurring across the coronary procedure differ between participants receiving Music Medicine and those receiving standard care. Between-group estimates will be reported with measures of statistical uncertainty and effect size where appropriate. Additional regression analyses may be performed to examine relationships between clinical or demographic characteristics and study variables.\n\nThe qualitative interviews will be analyzed using inductive qualitative content analysis. Transcripts will be read repeatedly and relevant meaning units will be identified, condensed, coded, and progressively organized into subcategories and descriptive categories. Where supported by the data, broader themes may also be identified.\n\nThe qualitative analysis will primarily focus on the manifest content of participants' accounts while also considering underlying meanings when clearly supported by the interview material. Analytical decisions and changes to the coding structure will be documented to promote transparency and traceability.\n\nThe integration of quantitative and qualitative information is intended to provide a more complete understanding of both the measurable effects of personalized Music Medicine and the way in which patients perceive and experience this intervention during coronary interventional cardiology procedures.\n\nMUSICOR is therefore designed not only to determine whether personalized Music Medicine has measurable effects during invasive coronary procedures, but also to assess whether this approach is acceptable and practical within the cardiac catheterization laboratory environment. If the intervention proves beneficial and feasible, it could support the development of a simple, patient-centered complementary strategy that can be incorporated alongside established clinical care without interfering with medical decision-making or procedural management.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Music Medicine arm","EXPERIMENTAL","Patients randomly allocated to the intervention group will listen to a personalized music playlist throughout the entire invasive cardiac procedure. The personalized playlist will be prepared as follows: a) On the day before the procedure, a healthcare professional trained in Music Medicine and in the study protocol will ask the patient which music they would like to listen to during the cardiac procedure. The healthcare professional will explain that the selected music should have characteristics associated with relaxation, calmness, and personal enjoyment, with the aim of reducing anxiety and pain. The patient will listen to the playlist through wireless earphones. b) The healthcare professional will prepare the playlist in the sequence selected by the patient and password-protect it on an MP3 device connected to Spotify. c) Before the procedure begins, a healthcare professional trained in Music Medicine and in the study protocol will place the earphones on the patient, access th",[56],"Other: Music Medicine intervention",{"label":58,"type":59,"description":60,"interventionNames":42},"Standard Care Arm","NO_INTERVENTION","Patients randomized to the control group will undergo the coronary cardiac procedure according to the standard clinical care routinely provided in the Cardiac Catheterization Laboratory of the University Hospital of Sassari (AOU Sassari). Standard care will include the usual preparation of the patient for the procedure, clinical and vital-sign monitoring, nursing and medical care throughout the procedure, and administration of pharmacological therapies, including analgesics and\u002For sedatives when clinically indicated, according to the operator's judgment and current clinical practice. The arterial access site, technical aspects of the procedure, and any additional treatment will be determined exclusively on the basis of the patient's clinical condition and routine care procedures. During the procedure, patients in the standard-care group will not use earphones and will not listen to either a personalized music playlist or any other music.",[62],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"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.",[52],[67],"Music Therapy",[69],{"name":70,"role":71,"phone":72,"phoneExt":42,"email":73},"Valentina Micheluzzi, PhD","CONTACT","+39 3401753630","valentina.micheluzzi@aousassari.it",[75],{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"SS Annunziata Hospital, Sassari","Sassari","Sardinia","07100","Italy","IT",{"type":83,"coordinates":84},"Point",[85,86],8.55552,40.72586,{"lat":86,"lon":85},[89],{"name":70,"role":71,"phone":72,"phoneExt":42,"email":73},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Valentina Micheluzzi","Principal Investigator","100653518","music-medicine-in-coronary-interventional-cardiology-procedures-100653518",false,"NCT07786961","Music Medicine in Coronary Interventional Cardiology Procedures","Effects of Music Medicine in Patients Undergoing Coronary Interventional Cardiology Procedures","MUSICOR","Inclusion Criteria:\n\n* age \\>18 years;\n* provision of written informed consent and ability to understand the informed consent form.\n\nExclusion Criteria:\n\n* patients with ST-segment elevation myocardial infarction (STEMI);\n* patients with very-high-risk non-ST-segment elevation myocardial infarction (NSTEMI), as classified according to the 2023 European Society of Cardiology (ESC) Guidelines;\n* patients in cardiogenic shock;\n* presence of hearing impairment or deafness, assessed through clinical history;\n* patients unable to express their musical preferences;\n* patients with resuscitated cardiac arrest;\n* use of antipsychotic medications, assessed through clinical history;\n* history of epilepsy, assessed through clinical history.","ALL","18 Years","80 Years",{"count":106,"type":107},208,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.\n\nThe 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",[113],"Acute Coronary Syndrome",[115,113,116,117],"Music Medicine","Percutaneous Coronary Intervention","Coronary Angiography","NOT_YET_RECRUITING","2026-08-25",{"date":121,"type":122},"2026-08-26","ACTUAL",{"date":124,"type":107},"2026-09-01",{"date":126,"type":107},"2029-10-31",{"name":5,"class":6},1]