Music Medicine in Coronary Interventional Cardiology Procedures

Coronary interventional cardiology procedures include invasive percutaneous proceduressuch as coronary angiography and percutaneous coronary intervention. These procedures areperformed in the cardiac catheterization laboratory and may last approximately 30 to 120minutes, depending on the clinical situation and procedural complexity. Although they areroutinely performed and are essential for the diagnosis and treatment of coronary arterydisease, the procedural environment, arterial access, manipulation of catheters andguidewires, 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 cardiovascularparameters and may also increase the perception of procedural pain. Pain itself may haveprocedural implications. In particular, during transradial procedures, pain anddiscomfort may contribute to radial artery spasm, which can make catheter manipulationmore difficult and, in some cases, require a change to another arterial access site.Pharmacological strategies, including analgesic and sedative medications, may be usedwhen clinically indicated to manage anxiety, discomfort, and pain during invasive cardiacprocedures. However, complementary non‐pharmacological approaches may provide additionalsupport without replacing or modifying standard clinical treatment.Music Medicine refers to the structured use of music within healthcare by trainedhealthcare professionals according to a defined protocol. In this study, Music Medicineis considered a complementary, patient‐centered intervention intended to make theprocedural experience more comfortable while preserving all aspects of routine medicaland nursing care. Previous research in cardiovascular settings has suggested thatmusic‐based interventions may have beneficial effects on psychological distress, anxiety,pain, blood pressure, heart rate, and overall patient well‐being. Music has also beenstudied during angiographic and cardiac catheterization procedures, but evidenceconcerning a fully personalized music intervention delivered throughout coronaryinterventional procedures remains limited.MUSICOR is a prospective, single‐center, open‐label, randomized controlled studyconducted at the Cardiac Catheterization Laboratory of the University Hospital ofSassari, Italy. A total of 208 participants undergoing invasive coronary interventionalcardiology procedures will be enrolled and randomly allocated in a 1:1 ratio to either aMusic Medicine group or a standard‐care group.Participants will be recruited consecutively during hospitalization. After enrollment andcompletion of baseline study procedures, participants will be assigned to one of the twostudy groups using a computer‐generated random allocation sequence. The randomizationsequence will be prepared by a data manager who is not involved in participantrecruitment or clinical management. Allocation will be implemented using sequentiallynumbered, opaque, sealed envelopes in order to prevent advance knowledge of groupassignment. Because participants in the intervention group will listen to music andhealthcare professionals must manage the music‐delivery system, blinding of participantsand clinical staff is not feasible.### Music Medicine InterventionParticipants assigned to the Music Medicine group will receive a personalized musicintervention in addition to routine clinical care.Before the coronary procedure, a healthcare professional trained in Music Medicine and inthe research protocol will discuss the participant's musical preferences. Rather thanprescribing a predetermined genre of music, the intervention is centered on theindividual participant's preferences. Participants will be encouraged to select musicthat they personally associate with relaxation, calmness, reassurance, or enjoyment.The participant may identify individual songs directly or may initially indicatepreferred artists, genres, or types of music from which appropriate tracks can then beselected. The final choice of music will remain patient‐centered. The participant willalso be able to determine the sequence in which the selected tracks are played.A personalized playlist will then be prepared according to the participant's selections.Before the coronary procedure begins, trained healthcare personnel will verify the audiosystem, prepare the playlist, and position wireless earphones. Playback will begin beforeor at the start of the invasive procedure and will continue throughout the procedureaccording to the predefined sequence selected by the participant.The audio system is designed so that the use of music does not prevent communicationbetween the participant and the healthcare team. Medical and nursing staff will remainable to communicate with the participant during the procedure through the studycommunication system whenever clinically necessary. Participants will therefore remain incontact with the clinical team and able to communicate needs or discomfort during theintervention.The 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 treatmentwill continue to be determined exclusively by the treating physicians according to theparticipant's clinical condition and routine clinical practice.The Music Medicine intervention may be discontinued at any time if requested by theparticipant or if interruption is considered necessary for clinical or proceduralreasons. At completion of the coronary procedure, the earphones will be removed and thedisposable components of the system will be discarded and replaced before use withanother participant.### Standard‐Care GroupParticipants assigned to the control group will undergo the coronary procedure accordingto the routine clinical and nursing care provided in the Cardiac CatheterizationLaboratory of the University Hospital of Sassari.Standard care includes routine preparation for the procedure, continuous clinicalmonitoring, monitoring of vital signs, medical and nursing assistance throughout theprocedure, and administration of pharmacological treatment, including analgesic and/orsedative medication when clinically indicated.The arterial access site, procedural strategy, interventional techniques, and anyadditional treatment will be selected according to the participant's clinical condition,physician judgment, and current clinical practice.Participants in the standard‐care group will not wear study earphones and will not listento either a personalized playlist or other music as part of the study during the coronaryprocedure. Apart from the Music Medicine intervention, clinical care will be comparablebetween the two study groups.### Study Assessments and Data CollectionThe study includes a baseline assessment before the coronary procedure and apost‐procedure assessment after completion of the intervention.At baseline, sociodemographic and clinically relevant information will be recorded tocharacterize the study population. These data include demographic characteristics andselected cardiovascular and clinical variables, such as cardiovascular risk profile,current medical therapy, left ventricular function, body mass index, functional status,and comorbidity burden.Study assessments will examine psychological, procedural, and physiological aspects ofthe participant's experience before and after the coronary procedure. The study will alsodocument procedural information relevant to arterial access and any need to change theinitially selected access site.All study data will be entered into a dedicated electronic database using the REDCapplatform.### Patient Experience ComponentIn addition to the quantitative comparison between the two randomized groups, MUSICORincludes a qualitative component intended to provide a more detailed understanding of howparticipants experience personalized music during an invasive coronary procedure.Participants who receive the Music Medicine intervention will be asked about theirsatisfaction with the intervention. They will also take part in an individualsemi‐structured interview conducted after the coronary procedure, at a time compatiblewith their clinical condition.The interview will be conducted by a psychologist using an open‐ended and non‐directiveapproach and will be audio‐recorded for subsequent transcription and analysis.Participants will be encouraged to describe the experience in their own words.The interview will explore several aspects of the intervention, including expectationsbefore the procedure, the meaning attributed to listening to music, perceived emotionaland physical effects, the importance of being able to personalize the playlist, comfortand acceptability of the earphones, communication with healthcare professionals whilelistening to music, perception of the catheterization laboratory environment and passageof time, and any positive, negative, or neutral aspects of the experience.Participants will also be invited to describe whether they would choose to usepersonalized music again during a similar future procedure and to provide suggestionsregarding music selection, playlist preparation, listening methods, or communication withclinical staff.The qualitative component is intended to complement the quantitative findings byidentifying aspects of acceptability, feasibility, and patient experience that may not befully captured through standardized measurements.### AnalysisQuantitative analyses will follow an intention‐to‐treat approach. Baselinecharacteristics of the study groups will be summarized using descriptive statistics, andthe comparability of the randomized groups will be examined using appropriate statisticaltests.For repeatedly assessed continuous variables, the principal analysis will consider bothtreatment group and time, as well as the interaction between treatment group and time, inorder to determine whether changes occurring across the coronary procedure differ betweenparticipants receiving Music Medicine and those receiving standard care. Between‐groupestimates will be reported with measures of statistical uncertainty and effect size whereappropriate. Additional regression analyses may be performed to examine relationshipsbetween clinical or demographic characteristics and study variables.The 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 descriptivecategories. Where supported by the data, broader themes may also be identified.The qualitative analysis will primarily focus on the manifest content of participants'accounts while also considering underlying meanings when clearly supported by theinterview material. Analytical decisions and changes to the coding structure will bedocumented to promote transparency and traceability.The integration of quantitative and qualitative information is intended to provide a morecomplete understanding of both the measurable effects of personalized Music Medicine andthe way in which patients perceive and experience this intervention during coronaryinterventional cardiology procedures.MUSICOR is therefore designed not only to determine whether personalized Music Medicinehas measurable effects during invasive coronary procedures, but also to assess whetherthis approach is acceptable and practical within the cardiac catheterization laboratoryenvironment. If the intervention proves beneficial and feasible, it could support thedevelopment of a simple, patient‐centered complementary strategy that can be incorporatedalongside established clinical care without interfering with medical decision‐making orprocedural management.