[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617767":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":22,"eligibilityCriteria":23,"healthyVolunteers":18,"sex":24,"minAge":25,"maxAge":10,"enrollmentInfo":26,"targetDuration":29,"studyType":30,"phases":10,"briefSummary":31,"conditions":32,"keywords":38,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"CIED-Implanted Patients",null,"This cohort includes adult patients who have undergone first-time implantation of a cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device) within the past year. Participants are prospectively followed at 3, 6, and 12 months after device implantation. Pain intensity is assessed using the Visual Analog Scale (VAS) and the DN-4 questionnaire, while objective pain sensitivity is measured using a digital pressure algometer. Quality of life is evaluated with the SF-12 form. Based on the one-year follow-up findings, patients will be categorized according to the presence or absence of chronic postsurgical pain (CPSP) to identify predictive risk factors and to develop an artificial intelligence-based clinical decision support model for early pain risk prediction.",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Gozde Altun","Assistant Professor","100617767","evaluation-of-chronic-postsurgical-pain-risk-in-patients-undergoing-cied-implantation-using-an-aid-support-system-100617767",false,"NCT07322900","Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System","Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing Cardiac Implantable Electronic Device (CIED) Implantation Using an Artificial Intelligence-Based Clinical Decision (AID) Support System","PAIN-AID","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Patients who have undergone first-time implantation of a cardiac implantable electronic device (CIED), including pacemaker (PM), implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT).\n* Device implantation performed within the past 12 months at Istanbul University-Cerrahpaşa Cardiology Institute.\n* Ability to attend scheduled follow-up visits at 3, 6, and 12 months post-implantation.\n* Ability to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of neuropathic or chronic pain syndromes prior to implantation (e.g., fibromyalgia, diabetic neuropathy).\n* Presence of neurodegenerative, autoimmune, or vascular disorders affecting peripheral or central pain pathways.\n* Known malignancy, active infection, or recent trauma in the chest or upper extremities.\n* Prior CIED replacement or battery exchange procedures.\n* Use of chronic analgesic or neuropathic pain medications (e.g., opioids, gabapentinoids, antidepressants) for conditions unrelated to the procedure.\n* Cognitive impairment or psychiatric disorders that may interfere with study participation or reliable pain assessment.\n* Inability to comply with follow-up or withdrawal of consent at any time.","ALL","18 Years",{"count":27,"type":28},180,"ESTIMATED","15 Months","OBSERVATIONAL","Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques. Patients receiving cardiac implantable electronic devices (CIEDs)-including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs)-constitute a unique population with high rates of multimorbidity, psychological vulnerability, and limited analgesic options due to cardiovascular comorbidities. Insufficient postoperative pain management in this group may lead to persistent pain at the generator site, neuropathic pain features, reduced quality of life, and increased healthcare utilization.\n\nThe present study aims to evaluate the prevalence, risk factors, and clinical predictors of CPSP following CIED implantation using both subjective and objective pain assessments. Pain intensity will be measured using validated self-report scales (Visual Analog Scale and DN-4 questionnaire), and objective pain thresholds will be determined using a calibrated digital pressure algometer. Quality of life will be assessed with the validated Turkish version of the Short Form-12 (SF-12) instrument.\n\nThis prospective observational study will include 180 adult patients who underwent first-time CIED implantation at Istanbul University-Cerrahpaşa, Cardiology Institute. Participants will be evaluated at 3, 6, and 12 months post-implantation. Collected data will include preoperative, intraoperative, and postoperative variables such as demographics, comorbidities, anesthesia type, surgical duration, and acute postoperative pain control.\n\nUsing the obtained data, an artificial intelligence-based clinical decision support system will be developed to predict individual CPSP risk before implantation. The model will integrate subjective scales, objective algometric data, and clinical factors to generate personalized risk estimates. Ultimately, this system aims to improve early detection and prevention of CPSP, optimize postoperative pain management strategies, and enhance patient quality of life.",[33,34,35,36,37],"Pain Measurement","Chronic Pain","Cardiac Implantable Electrical Devices","Neuropathic Pain","Chronic Post Surgical Pain",[39,40,41,34,42,43,44,45],"Cardiac Resynchronization Therapy Devices","Pacemaker, Artificial","Defibrillators, Implantable","Quality of Life","Artificial Intelligence","Decision Support Systems, Clinical","postoperative pain","NOT_YET_RECRUITING","2026-05-04",{"date":49,"type":50},"2026-05-05","ACTUAL",{"date":52,"type":28},"2026-09-30",{"date":54,"type":28},"2027-03-01",{"name":5,"class":6}]