[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597878":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":42,"responsibleParty":61,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":98,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Video Group","EXPERIMENTAL","Participants watch an educational video about perineal tears and episiotomy via QR code before active labor.",[13],"Behavioral: Behavioral: Educational Video",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Receives standard care without video",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Behavioral: Educational Video","Participants will watch a 2-minute educational video in Hebrew about perineal tears and episiotomy. The video includes information about types and grades of tears, risk factors, prevention strategies, episiotomy use, healing process, and when to seek help. The video is presented on a secure mobile device by the research team before the onset of active labor.",[9],[26,29,32],{"name":27,"affiliation":5,"role":28},"Ilia Kleiner, MD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":31},"Hagit Eisenberg, MD","STUDY_DIRECTOR",{"name":33,"affiliation":5,"role":31},"Julia Barda Fishler, MD",[35,39],{"name":27,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","+972-52-8305195","kleiner.ilia@gmail.com",{"name":30,"role":36,"phone":40,"phoneExt":18,"email":41},"+972 52 3397843","hagiteisen@yahoo.com",[43],{"facility":5,"status":18,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Tel Aviv","6997107","Israel","IL",{"type":49,"coordinates":50},"Point",[51,52],34.78057,32.08088,{"lat":52,"lon":51},[55,56,57,58,60],{"name":30,"role":36,"phone":40,"phoneExt":18,"email":41},{"name":27,"role":36,"phone":37,"phoneExt":18,"email":38},{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":30,"role":59,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":33,"role":59,"phone":18,"phoneExt":18,"email":18},{"type":28,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"ilia kleiner","Specialist Obstetrician & Gynecologist; Director, Labor and Delivery Rooms and Maternity Department","100597878","an-informative-video-about-perineal-tears-during-labor-for-anxiety-reduction-a-randomized-controlled-trial-100597878",false,"NCT07064213","An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial","Effect of an Informative Video About Perineal Tears on Anxiety During Labor: A Randomized Controlled Trial","VITAL","Inclusion:\n\nPrimiparous women\n\nAge ≥18\n\nGestational age ≥37 weeks\n\nFluent in Hebrew (able to complete STAI-S)\n\nExclusion:\n\nIUFD\n\nPregnancy termination\n\nDiagnosis of anxiety disorder\n\nLanguage barrier (cannot complete STAI-S)",true,"FEMALE","18 Years","45 Years",{"count":77,"type":78},110,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is associated with significant physical and psychological consequences, including anxiety, shame, fear, and social isolation. Despite growing awareness, many women report inadequate knowledge and preparation regarding these outcomes before labor.\n\nThis prospective, single-center, randomized controlled trial will be conducted at Edith Wolfson Medical Center in Holon, Israel. A total of 110 primiparous women admitted for induction or early labor will be recruited prior to the active phase of labor. Participants will be randomized into two groups in a 1:1 ratio. The intervention group will watch a 2-minute educational video explaining the types, implications, and prevention strategies related to perineal tears. The control group will receive standard care without video exposure.\n\nThe primary objective is to assess change in maternal anxiety using the validated State-Trait Anxiety Inventory (STAI-S) questionnaire, measured at baseline and 2-24 hours postpartum. Secondary outcomes include satisfaction with the video (in the intervention group), rates of perineal tears, episiotomy, and OASIS. Data will be collected from the hospital's EMR system and patient-reported questionnaires, stored securely and coded. The study aims to determine whether increasing knowledge through a short educational intervention can reduce childbirth-related anxiety and improve the birth experience.",[84],"Anxiety",[86,87,88,89,90,91,92,93,94,95,96,97],"Perineal Tears","Childbirth Education","Primiparous Women","Labor and Delivery","Childbirth-Related Anxiety","Intrapartum Anxiety","Obstetric trauma","Episiotomy","Vaginal delivery","OASIS","STAI-S","Maternal mental health","NOT_YET_RECRUITING","2025-07-02",{"date":101,"type":102},"2025-07-14","ACTUAL",{"date":104,"type":78},"2025-07-10",{"date":106,"type":78},"2026-07-10",{"name":5,"class":6},1]