[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651440":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":39,"armGroups":43,"interventions":50,"overallOfficials":55,"centralContacts":62,"locations":67,"responsibleParty":84,"collaborators":39,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":39,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":39,"enrollmentInfo":96,"targetDuration":39,"studyType":99,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":70,"whyStopped":39,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Mostar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)","To assess in resilience in men undergoing transrectal prostate biopsy after structured peri-procedural nursing Intervention.","Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Change in anxiety measured by the Hamilton Anxiety Rating Scale (HAM-A)","To assess changes in anxiety levels in men undergoing transrectal prostate biopsy following structured peri-procedural nursing Intervention.","Baseline (7 days before biopsy), and 2-3 weeks after biopsy following disclosure of histopathological results.",{"measure":19,"description":20,"timeFrame":12},"Change in lower urinary tract symptoms associated with the biopsy procedure and recovery.","To assess changes in lower urinary tract symptoms associated with the biopsy procedure and recovery.",{"measure":22,"description":23,"timeFrame":24},"Pain intensity measured by the Numeric Rating Scale (NRS)","To assess pain intensity experienced after transrectal prostate biopsy.","0-24 hours after biopsy.",{"measure":26,"description":27,"timeFrame":28},"Perception of nursing care measured by a structured patient questionnaire","To assess patients perception of peri-procedural nursing care, comminication, emotional support, and information provided.","0-24 hours after biopsy and 2-3 weeks after biopsy.",[30],{"measure":31,"description":32,"timeFrame":33},"Histopathological disgnosis after prostate biopsy","Histopathological biopsy results will be recorded and participants will be stratified into benign and malignant disgnosis groups for pre-specified subgroup analyses.","2-3 weeks after prostate biopsy, when histopathological results are disclosed.",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":39,"timePerspective":39,"maskingInfo":40},"NA","SINGLE_GROUP","All participants will receive the same structured peri-procedural nursing Intervention and will be followed longitudinally at predefined study time points.","SUPPORTIVE_CARE",null,{"masking":41,"maskingDescription":39,"whoMasked":39},"NONE","This is a prospective, single-center, longitudinal interventional study conducted at the Department of Urology, University Clinical Hospital Mostar, Bosnia and Herzegovina.\n\nThe objective is to determine whether structured peri-procedural nursing interventions improve resilience and reduce anxiety in men undergoing transrectal prostate biopsy.\n\nParticipants will be assessed at three time points:\n\n* baseline before the biopsy,\n* 0-24 Houra after the procedure\n* 2-3 weeks after the biopsy after receiving histopathological results. The study outcomes include resilience, anxiety, pain, lower urinary tract symptoms, and patients perception of nursing support.\n\nHistopathological disgnosis (benign or malignant) will be used for subgroup analyses.\n\nApproximately 120-140 participants are expected to be enrolled, with an anticipated final sample of approximately 100-110 participants after follow-up.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Structured peri-procedural nursing Intervention","EXPERIMENTAL","All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy.",[49],"Behavioral: Structured peri-procedural nursing Intervention",[51],{"type":52,"name":45,"description":53,"armGroupLabels":54,"otherNames":39},"BEHAVIORAL","The structured peri-procedural nursing Intervention includes standardized patient education, procedral preparation, comminication, emotional support, and nursing care provided before, during, and after transrectal prostate biopsy. All participants receive the same Intervention according to the predefined study protocol.",[45],[56,59],{"name":57,"affiliation":5,"role":58},"Maja Ardjelan, MSc","PRINCIPAL_INVESTIGATOR",{"name":60,"affiliation":5,"role":61},"Katica Pavlović, MD, PhD","STUDY_CHAIR",[63],{"name":57,"role":64,"phone":65,"phoneExt":39,"email":66},"CONTACT","00387 36 336 162","majaardjelan555@gmail.com",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University Clinical Hospital Mostar","RECRUITING","Mostar","Federation of Bosnia and Herzegovina","88000","Bosnia and Herzegovina","BA",{"type":77,"coordinates":78},"Point",[79,80],17.80806,43.34333,{"lat":80,"lon":79},[83],{"name":57,"role":64,"phone":65,"phoneExt":39,"email":66},{"type":58,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Maja Arđelan","Principal Investigator","100651440","structured-periprocedural-nursing-interventions-in-men-undergoing-transrectal-prostate-biopsy-100651440",false,"NCT07760688","Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy","Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification","Inclusion Criteria:\n\n* Male participants aged 40 years or older.\n* Scheduled for transrectal ultrasound-guided prostate biopsy because of suspected prostate cancer.\n* Able to understand the study procedures and provide written informed consent.\n* Willing to complete all study assessments during the follow-up period.\n\nExclusion Criteria:\n\n* Inabillity to provide informed consent.\n* Severe cognitive impairment or psychiatric disorder preventing questionnaire completion.\n* Previous disgnosis of prostate cancer.\n* Inabillity to complete follow-up assessments.\n* Withdrawal of informed consent at any time.","MALE","40 Years",{"count":97,"type":98},120,"ESTIMATED","INTERVENTIONAL",[35],"This prospective longitudinal interventional study aims to evaluate the effect of structured peri-procedural nursing interventions on resilience and anxiety in men undergoing transrectal prostate biopsy. Participants will receive a standardized nursing intervention before and after the biopsy procedure. Resilience, anxiety, pain, lower urinary tract symptoms, and perceived nursing support will be assessed at predefined time points. Histopathological findings (benign or malignant) will be used for subgroup analyses. The study is conducted at the University Clinical Hospital Mostar, Bosnia and Herzegovina.",[103,104],"Anxiety","Biopsy",[106,107,108,109,110,111,112,113,114],"Prostate biopsy","Resilience","Nursing Intervention","Periprocedural nursing care","Prostate cancer","Patient education","Lower urinary tract symptoms","Hamilton Anxiety Rating Scale","International Prostate Symptom Score","2026-08-07",{"date":117,"type":118},"2026-08-12","ACTUAL",{"date":120,"type":118},"2026-08-04",{"date":122,"type":98},"2027-08-04",{"name":5,"class":6},1]