[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597878":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":19,"armGroups":32,"interventions":43,"overallOfficials":49,"centralContacts":58,"locations":66,"responsibleParty":85,"collaborators":19,"id":88,"slug":19,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":19,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":121,"whyStopped":19,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Change in maternal anxiety score","The primary outcome is the change in maternal anxiety as measured by the State-Trait Anxiety Inventory - State version (STAI-S). This validated questionnaire includes 20 items that assess situational anxiety on a 4-point scale, with total scores ranging from 20 to 80. Higher scores indicate greater anxiety. The STAI-S will be administered at two time points: (1) upon enrollment, before the active phase of labor begins, and (2) 2 to 24 hours after delivery. The difference in scores between these two time points will be compared between the intervention and control groups to assess whether viewing a short, informative video about perineal tears reduces anxiety during labor.","2-24 hours postpartum",[14,17,21,23],{"measure":15,"description":16,"timeFrame":12},"Satisfaction with video (intervention group only)","Satisfaction with the educational video will be assessed in the intervention group only. Participants will complete a brief, structured questionnaire within 2 to 24 hours postpartum. The questionnaire includes items assessing perceived usefulness, clarity of information, emotional impact, and whether the video helped them feel more prepared for labor and perineal outcomes.",{"measure":18,"description":19,"timeFrame":20},"Rate of perineal tears",null,"During delivery",{"measure":22,"description":19,"timeFrame":20},"Rate of episiotomy",{"measure":24,"description":19,"timeFrame":20},"Rate of OASIS",{"allocation":26,"interventionModel":27,"interventionModelDescription":19,"primaryPurpose":28,"observationalModel":19,"timePerspective":19,"maskingInfo":29},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":19,"whoMasked":19},"NONE","Background and Rationale:\n\nPerineal tears during vaginal delivery are a common obstetric complication, affecting both the physical and emotional well-being of mothers. Numerous studies have highlighted the psychological burden associated with severe tears, including obstetric anal sphincter injuries (OASIS). These can result in postpartum depression, posttraumatic stress symptoms (PTS), anxiety, and disruption to intimate and social relationships.\n\nA comprehensive review by Darmody et al. (2020) and qualitative synthesis by Priddis et al. (2013) have shown that women experiencing significant perineal trauma may report feelings of shame, loneliness, failure, and fear, often amplified by insufficient understanding or preparation before delivery. More recent studies (Opondo et al., 2023; Baumann et al., 2024) found that the severity of tears correlates with psychological morbidity postpartum, including childbirth-related PTSD.\n\nThese findings underscore the importance of providing accessible, accurate information to women before delivery to empower them, reduce fear, and foster realistic expectations. However, no randomized controlled trial has yet evaluated whether a brief, targeted educational intervention specifically about perineal tears can reduce anxiety when given just before the active phase of labor.\n\nStudy Objective:\n\nTo evaluate whether viewing a short, informative video about perineal tears before the onset of active labor reduces maternal anxiety.\n\nStudy Design:\n\nThis is a prospective, randomized controlled trial (RCT) with two parallel arms. The study will be conducted at Edith Wolfson Medical Center, Holon, Israel, over a 12-month period. A total of 110 primiparous women ≥18 years old at ≥37 weeks gestation will be recruited from the Maternal-Fetal Medicine Unit or Delivery Room prior to active labor.\n\nEligibility Criteria:\n\nInclusion:\n\nPrimiparous women\n\nAge 18-45\n\nGestational age ≥37 weeks\n\nFluent in Hebrew (able to complete STAI-S questionnaire)\n\nExclusion:\n\nIntrauterine fetal death\n\nTermination of pregnancy\n\nKnown anxiety disorder\n\nLanguage barrier\n\nCesarean section during labor\n\nWithdrawal of consent\n\nRandomization:\n\nParticipants will be randomly assigned (1:1) to the intervention or control group. Randomization will be done using computerized block randomization by the study team.\n\nIntervention:\n\nThe intervention group will watch a 2-minute educational video (in Hebrew) produced by the research team. The video provides information on types and degrees of perineal tears, the role of episiotomy, possible symptoms, healing, and preventative techniques. Viewing will take place using the researchers' secure mobile device.\n\nThe control group will receive routine intrapartum care with no additional information.\n\nOutcomes:\n\nPrimary Outcome:\n\nChange in STAI-S anxiety score from before active labor to 2-24 hours postpartum\n\nSecondary Outcomes:\n\nSatisfaction with the video (intervention group only)\n\nRate of perineal tears (any grade)\n\nRate of episiotomy\n\nRate of obstetric anal sphincter injuries (OASIS)\n\nData Collection and Analysis:\n\nAnxiety will be assessed using the validated Hebrew version of the STAI-S questionnaire at two time points:\n\nAt enrollment, before active labor\n\n2-24 hours after delivery\n\nDemographic, clinical, and birth data will be extracted from the Chameleon hospital EMR system. Data will include: age, BMI, parity, pregnancy complications, labor duration, birthweight, Apgar scores, pH umbilical, and neonatal unit admission. All data will be anonymized and stored on password-protected hospital systems.\n\nStatistical analysis will use SPSS v30. Continuous variables will be compared using t-tests, categorical variables with chi-square tests. p \\\u003C 0.05 will be considered statistically significant.\n\nSample Size Justification:\n\nA pilot evaluation of 10 women showed mean STAI-S scores of 41 (SD = 11). Assuming a 15% reduction in anxiety in the intervention group, with α=0.05 and 80% power, 100 participants are required. Accounting for 10% loss to follow-up, the final sample is 110 (55 per arm).\n\nEthics and Privacy:\n\nAll participants will provide informed consent before enrollment. Data will be stored in coded form, with no personal identifiers. Participants may withdraw at any point. Ethics approval is\u002Fwill be granted by the Wolfson Medical Center Helsinki Committee.\n\nThe study is expected to contribute valuable data on whether a low-cost, scalable educational tool can reduce childbirth anxiety and improve maternal emotional outcomes.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Video Group","EXPERIMENTAL","Participants watch an educational video about perineal tears and episiotomy via QR code before active labor.",[38],"Behavioral: Behavioral: Educational Video",{"label":40,"type":41,"description":42,"interventionNames":19},"Control Group","NO_INTERVENTION","Receives standard care without video",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":19},"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.",[34],[50,53,56],{"name":51,"affiliation":5,"role":52},"Ilia Kleiner, MD","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":5,"role":55},"Hagit Eisenberg, MD","STUDY_DIRECTOR",{"name":57,"affiliation":5,"role":55},"Julia Barda Fishler, MD",[59,63],{"name":51,"role":60,"phone":61,"phoneExt":19,"email":62},"CONTACT","+972-52-8305195","kleiner.ilia@gmail.com",{"name":54,"role":60,"phone":64,"phoneExt":19,"email":65},"+972 52 3397843","hagiteisen@yahoo.com",[67],{"facility":5,"status":19,"city":68,"state":19,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Tel Aviv","6997107","Israel","IL",{"type":73,"coordinates":74},"Point",[75,76],34.78057,32.08088,{"lat":76,"lon":75},[79,80,81,82,84],{"name":54,"role":60,"phone":64,"phoneExt":19,"email":65},{"name":51,"role":60,"phone":61,"phoneExt":19,"email":62},{"name":51,"role":52,"phone":19,"phoneExt":19,"email":19},{"name":54,"role":83,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":57,"role":83,"phone":19,"phoneExt":19,"email":19},{"type":52,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"ilia kleiner","Specialist Obstetrician & Gynecologist; Director, Labor and Delivery Rooms and Maternity Department","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":100,"type":101},110,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107],"Anxiety",[109,110,111,112,113,114,115,116,117,118,119,120],"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":124,"type":125},"2025-07-14","ACTUAL",{"date":127,"type":101},"2025-07-10",{"date":129,"type":101},"2026-07-10",{"name":5,"class":6},1]