[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658571":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":81,"studyPopulation":74,"armGroups":82,"interventions":93,"overallOfficials":98,"centralContacts":103,"locations":111,"responsibleParty":129,"collaborators":74,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":74,"enrollmentInfo":142,"targetDuration":74,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":160,"whyStopped":74,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":74},[9],{"measure":10,"description":11,"timeFrame":12},"POD incidence","The occurrence of POD will be assessed once daily by research nurses from postoperative day 1 until postoperative day 5 using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). The 3D-CAM consists of patient interviews, cognitive testing, and observer ratings. To decide whether a patient has developed POD, the standard Confusion Assessment Method (CAM) diagnostic algorithm is applied. A positive POD diagnosis is confirmed if the following features are present: 1) acute onset or fluctuating course, and 2) inattention, and 3) either disorganized thinking or 4) altered level of consciousness. Additionally, patients' records will be reviewed using the Chart-based Delirium Identification Instrument (CHART-DEL).","Daily on postoperative days 1 through 5, or until hospital discharge, whichever occurs first.",[14,18,21,24,27,30,33,37,40,43,46,49,52,56,59,63,67,71],{"measure":15,"description":16,"timeFrame":17},"Preoperative anxiety assessed by the Amsterdam Preoperative Anxiety and Information Scale","The preoperative anxiety level will be assessed using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale (APAIS-A) before and after receiving the music intervention. APAIS-A consists of 4 items; each item is scored from 1 to 5. The APAIS-A score is the sum of the four item scores, with a scoring range from 4 (not anxious) to 20 (highly anxious).","From admission to the day of surgery, an average of 2 days",{"measure":19,"description":20,"timeFrame":17},"Preoperative anxiety assessed by the Visual Analogue Scale for Anxiety","The Visual Analogue Scale for Anxiety (VAS-A) is a 100-millimeter (mm) horizontal line anchored by \"not at all anxious\" at 0 mm and \"most anxious imaginable\" at 100 mm. Participants will mark the point on the line that best reflects the current level of anxiety.",{"measure":22,"description":23,"timeFrame":12},"The severity of postoperative delirium (3D-CAM-S)","The severity of POD will be assessed daily from postoperative day 1 to postoperative day 5 using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium Severity (3D-CAM-S). The 3D-CAM-S raw severity score ranges from 0 to 20 points. Higher scores on both scales indicate greater delirium severity.",{"measure":25,"description":26,"timeFrame":12},"The severity of postoperative delirium (DOSS)","The severity of POD will be assessed daily from postoperative day 1 to postoperative day 5 using the Delirium Observation Screening Scale (DOSS). The DOSS score ranges from 0 to 13 points. Higher scores on both scales indicate greater delirium severity.",{"measure":28,"description":29,"timeFrame":12},"Delirium subtypes","Delirium motor subtypes will be assessed using the Delirium Motor Subtyping Scale-4 (DMSS-4). Participants with delirium will be classified as having a hyperactive, hypoactive, mixed, or no motor subtype based on the DMSS-4 criteria.",{"measure":31,"description":32,"timeFrame":12},"Perioperative medication use","Perioperative medication use, including antipsychotics, anxiolytics, analgesics, hypnotics, and sedatives, will be extracted from the inpatient medical records.",{"measure":34,"description":35,"timeFrame":36},"Anaesthetic drug dosage","Anaesthetic drug dosage for induction and maintenance will be obtained from the anesthesia records, including agents and quantities administered.","Intraoperative",{"measure":38,"description":39,"timeFrame":36},"Mean intraoperative systolic blood pressure","Systolic blood pressure will be obtained from the anesthesia record. The mean systolic blood pressure recorded during surgery will be calculated and reported in millimeters of mercury (mmHg).",{"measure":41,"description":42,"timeFrame":36},"Mean intraoperative heart rate","Heart rate will be obtained from the anesthesia record. The mean heart rate recorded during surgery will be calculated and reported in beats per minute (bpm).",{"measure":44,"description":45,"timeFrame":36},"Mean intraoperative diastolic blood pressure","Diastolic blood pressure will be obtained from the anesthesia record. The mean diastolic blood pressure recorded during surgery will be calculated and reported in millimeters of mercury (mmHg).",{"measure":47,"description":48,"timeFrame":12},"Postoperative pain","Postoperative pain will be assessed daily during the first five postoperative days using the Visual Analogue Scale for Pain (VAS-P). Scores range from 0 to 100 mm, with 0 mm indicating no pain and 100 mm indicating the worst imaginable pain. Higher scores indicate greater pain intensity.",{"measure":50,"description":51,"timeFrame":12},"Postoperative complications","Postoperative complications occurring during hospitalization will be identified from the inpatient medical records. Prespecified complications will include pneumonia, stroke, myocardial infarction, reoperation, bleeding, and infection. Other clinically relevant postoperative complications will be recorded under an \"Other\" category.",{"measure":53,"description":54,"timeFrame":55},"Length of hospital stay","Length of hospital stay will be calculated as the number of days from hospital admission to hospital discharge, based on the inpatient medical record.","From hospital admission to hospital discharge, assessed up to 10 days.",{"measure":57,"description":58,"timeFrame":17},"Perceived relaxation after the music intervention","After each of the first two music interventions, participants will rate the level of relaxation using four response options: \"Not at all,\" \"Somewhat relaxed,\" \"Quite relaxed,\" and \"Very relaxed.\"",{"measure":60,"description":61,"timeFrame":62},"Compliance rate","The compliance rate refers to one session with 20 minutes or more of music intervention.","From admission to postoperative day 5, or until hospital discharge, whichever occurs first.",{"measure":64,"description":65,"timeFrame":66},"Acceptability of music intervention","Participant satisfaction, experience with the music intervention, and willingness to use music again during a future surgery or procedure will be assessed via a short interview.","Postoperative day 5, or hospital discharge, whichever occurs first.",{"measure":68,"description":69,"timeFrame":70},"Participants' preferences regarding the music intervention","Participants' preferences regarding intervention details, including music selection, number of sessions, session duration, setting, and implementation timing, will be assessed via a short interview.","Postoperative day 1",{"measure":72,"description":73,"timeFrame":70},"Barriers to receiving the music intervention","Barriers experienced during the music intervention will be assessed via a short interview.",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":78,"observationalModel":74,"timePerspective":74,"maskingInfo":79},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":80,"maskingDescription":74,"whoMasked":74},"NONE","Background:\n\nPostoperative delirium (POD) is a common and serious complication among older patients undergoing cardiac surgery. POD is characterized by an acute and fluctuating disturbance in attention and cognition and is associated with prolonged hospital stays, increased morbidity and mortality, functional decline, and substantial healthcare costs. Although various preventive strategies have been investigated, POD remains a major challenge in perioperative care. An important but often underestimated risk factor is preoperative anxiety (PA), which affects approximately half of patients undergoing cardiac surgery. PA is associated with increased psychological stress and greater requirements for anesthetic agents and postoperative analgesics, factors that may in turn increase the risk of POD. Reducing PA is therefore considered a promising strategy for POD prevention.\n\nAs pharmacological treatments for anxiety and delirium may be associated with adverse effects, particularly in older and vulnerable patients, there is growing interest in non-pharmacological interventions. Music intervention is particularly attractive because of the favorable safety profile, low cost, ease of implementation, and high patient acceptability. Although previous studies suggest that music may reduce preoperative anxiety and potentially have a beneficial effect on the prevention of POD, the findings remain inconclusive, and many studies have methodological limitations. Moreover, other relevant outcomes, such as delirium severity, postoperative pain, and cost-effectiveness, have often been insufficiently investigated.\n\nTherefore, a prospective, single-center, randomized controlled trial will be conducted among older patients undergoing elective cardiac surgery at University Hospitals Leuven. A total of 256 patients will be enrolled and randomly assigned to either an intervention group or a control group. In addition to standard care, participants in the intervention group will receive a structured perioperative music intervention delivered via headphones and smartphones, whereas participants in the control group will receive standard care alone.\n\nThe primary aim of this study is to evaluate the effectiveness of a music intervention in preventing postoperative delirium. The occurrence of POD during the first five postoperative days will be assessed using validated delirium assessment tools, including the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM), the Chart-based Delirium Identification Instrument (CHART-DEL), and the Delirium Observation Screening Scale (DOSS). In addition, the study will investigate the effects of the music intervention on preoperative anxiety, POD severity, postoperative pain, perioperative medication use, anesthetic requirements, intraoperative hemodynamic parameters, postoperative complications, and length of hospital stay. Exploratory analyses will also examine the potential role of preoperative anxiety in the relationship between the music intervention and the occurrence of POD.\n\nPrimary objective:\n\nTo determine whether a structured perioperative music intervention in addition to standard care reduces the incidence of POD within the first five postoperative days among older adults undergoing elective cardiac surgery, compared with standard care alone.\n\nSecondary objective:\n\n1. To evaluate the effects of the structured perioperative music intervention on other clinically relevant perioperative and postoperative outcomes, including PA, POD severity, perioperative medication use, anesthetic drug dosage, postoperative pain, postoperative complications, and length of hospital stay.\n2. To explore whether baseline PA and changes in PA during the preoperative period are associated with the incidence of POD.\n\nSetting: This clinical trial will be conducted in the Department of Cardiovascular Surgery of the University Hospitals Leuven.\n\nOverall methodology:\n\nThis study is a prospective, single-center, two-arm, parallel-group randomized controlled trial (RCT).\n\nA total of 256 participants aged ≥65 years undergoing elective cardiac surgery will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a centralized, computer-generated randomization procedure implemented through Research Electronic Data Capture (REDCap). Randomization will be performed after eligibility has been confirmed, written informed consent has been obtained, and baseline assessments have been completed. The allocation sequence will be generated using variable block sizes and concealed from personnel involved in participant recruitment and trial conduct until allocation.\n\nParticipants in the intervention group will receive a structured perioperative music intervention in addition to standard perioperative care. The intervention consists of approximately eight music-listening sessions of 20-30 minutes each, delivered through headphones and smartphones from the evening before surgery through postoperative day 5 or until hospital discharge, whichever occurs first. Participants will be able to select music according to participant preferences from standardized playlists developed for the study. Participants in the control group will receive standard perioperative care without the study music intervention. Non-study music exposure will be documented in both groups to assess potential contamination.\n\nThe study will follow an open-label design because blinding of participants, intervention providers, clinical staff, and outcome assessors is not feasible given the nature of the intervention. To minimize potential bias, study procedures and outcome assessments will be standardized, and statistical analyses will be conducted by a statistician blinded to treatment allocation.\n\nThe primary outcome is the incidence of POD within the first five postoperative days. Secondary outcomes include preoperative anxiety, POD severity, delirium subtypes, perioperative medication use, anesthetic drug dosage for induction and maintenance, intraoperative hemodynamic variables, postoperative pain, postoperative complications, and length of hospital stay.\n\nThe primary outcome will be analyzed in the Full Analysis Set (FAS) using robust Poisson regression with an identity link to estimate the treatment effect and 95% confidence interval, with randomized treatment group as the primary model factor. Sensitivity analyses will adjust for prespecified baseline covariates, including age, sex, baseline cognitive status, type of surgery, and habitual music-listening behavior, and will also be conducted using the Secondary Estimand and the Per-Protocol Set (PPS). Secondary analyses of the primary outcome will include time-to-event analyses using Kaplan-Meier methods and Cox regression. Binary secondary outcomes will be analyzed using robust Poisson regression, and repeated continuous outcomes will primarily be analyzed using constrained longitudinal data analysis (cLDA). Length of hospital stay will be analyzed as time to live discharge, with in-hospital death treated as a competing risk. Prespecified exploratory subgroup analyses will examine treatment-effect heterogeneity by age, type of surgery, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), habitual music listening, and baseline preoperative anxiety using treatment-by-subgroup interaction terms. Exploratory analyses will also assess associations between baseline preoperative anxiety, changes in preoperative anxiety, and postoperative delirium incidence. All randomized participants will be included in the primary estimand analyses regardless of treatment completion or follow-up status. Missing outcome data will primarily be handled using multiple imputation under the Missing At Random assumption, with sensitivity analyses conducted where appropriate. Treatment effects will be interpreted based on effect estimates, 95% confidence intervals, and clinical relevance.",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Music intervention group","EXPERIMENTAL","Participants in the intervention group will receive eight perioperative music sessions in addition to standard care. Each session will last approximately 20-30 minutes. Two sessions will be provided preoperatively (on the evening before surgery and on the morning of surgery), followed by six postoperative sessions (one in the recovery room and one daily from postoperative day 1 to day 5).\n\nMusic will be delivered via smartphones and wireless headphones using participant-selected playlists on Spotify. A trained research nurse will provide instructions and assistance with the equipment. The number and duration of completed music sessions will be documented.",[88],"Other: Music Intervention Group",{"label":90,"type":91,"description":92,"interventionNames":74},"Routine care","NO_INTERVENTION","Participants in the control group will receive standard perioperative care without any music intervention. Any active or passive music listening will be documented, including the timing and type of music.",[94],{"type":6,"name":95,"description":96,"armGroupLabels":97,"otherNames":74},"Music Intervention Group","Participants will receive eight perioperative music sessions in addition to standard care. Each session will last approximately 20-30 minutes. Two sessions will be provided preoperatively (on the evening before surgery and on the morning of surgery), followed by six postoperative sessions (one in the recovery room and one daily from postoperative day 1 to day 5). Music will be delivered via smartphones and wireless headphones using participant-selected playlists on Spotify. A trained research nurse will provide instructions and assistance with the equipment. The number and duration of completed sessions will be documented.",[84],[99],{"name":100,"affiliation":101,"role":102},"Koen Milisen","Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven & Department of Geriatric Medicine, University Hospital Leuven, Leuven, Belgium.","PRINCIPAL_INVESTIGATOR",[104,109],{"name":105,"role":106,"phone":107,"phoneExt":74,"email":108},"Sining Zeng","CONTACT","+32 16 37 79 79","sining.zeng@kuleuven.be",{"name":105,"role":106,"phone":110,"phoneExt":74,"email":108},"+32 491334338",[112],{"facility":113,"status":74,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"University Hospital Leuven","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":120,"coordinates":121},"Point",[122,123],4.70093,50.87959,{"lat":123,"lon":122},[126,128],{"name":100,"role":106,"phone":107,"phoneExt":74,"email":127},"koen.milisen@kuleuven.be",{"name":105,"role":106,"phone":110,"phoneExt":74,"email":108},{"type":102,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"prof. dr. Koen Milisen","Full professor","100658571","music-intervention-to-reduce-anxiety-and-prevent-delirium-in-older-adults-undergoing-cardiac-surgery-100658571",false,"NCT07851194","Music Intervention to Reduce Anxiety and Prevent Delirium in Older Adults Undergoing Cardiac Surgery","Music Intervention for rEduction of Preoperative Anxiety and Prevention of Postoperative deLirium in Older aDults Undergoing Cardiac surgerY","MELODY","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or the participant's legally authorized representative has been obtained prior to any screening procedures\n* At least 65 years of age at the time of signing the Informed Consent Form (ICF)\n* Scheduled for elective cardiac surgery.\n* Able to participate and communicate in Dutch.\n\nExclusion Criteria:\n\n* Participant has a history of music-induced seizures.\n* Inability to use headphones or smartphones.\n* Deafness or severe hearing impairment, defined as being unable to listen to music.\n* Presence of delirium at baseline, as screened with the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).\n* Disabling neurological diseases, including stroke, dementia, and active epilepsy (requiring ongoing anti-epileptic medication).\n* Current treatment with anxiolytics, antidepressants, or antipsychotics.\n* Admission on the day of surgery.\n* Expected postoperative intensive care unit (ICU) admission longer than one day.\n* Participation in an interventional study with an investigational medicinal product (IMP) or device.","ALL","65 Years",{"count":143,"type":144},256,"ESTIMATED","INTERVENTIONAL",[147],"NA","The goal of this clinical trial is to evaluate the effectiveness of the music intervention in preventing postoperative delirium (POD) in older patients undergoing elective cardiac surgery.\n\nThe primary question is: Among older adults undergoing elective cardiac surgery, does offering a structured perioperative music intervention in addition to standard care reduce the incidence of POD within the first five postoperative days compared with standard care alone? The secondary questions are: Does perioperative music intervention reduce preoperative anxiety (PA) among older patients undergoing cardiac surgery, and does the level of PA moderate the effect of the music intervention on POD?\n\nResearchers will compare music intervention to routine care to see if music intervention can reduce PA and prevent POD.\n\nParticipants will listen to music before and after surgery, be assessed for PA and POD, and participate in an interview about participants' perspectives on the music intervention.",[150,151,152],"Postoperative Delirium","Preoperative Anxiety","Cardiac Surgery",[154,155,156,157,158,159],"postoperative delirium","music intervention","preoperative anxiety","randomized controlled trial","cardiac surgery","older adults","NOT_YET_RECRUITING","2026-09-30",{"date":163,"type":164},"2026-10-01","ACTUAL",{"date":163,"type":144},{"date":167,"type":144},"2028-04-15",{"name":5,"class":6},1]