[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610142":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":23,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":23,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":87,"overallStatus":100,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Standard postpartum care","ACTIVE_COMPARATOR",[12],"Other: Standard of Care (SOC)",{"label":14,"type":15,"description":14,"interventionNames":16},"Generative AI Chatbot Intervention","EXPERIMENTAL",[17,12],"Other: Generative artificial intelligence (genAI) postpartum chatbot",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Generative artificial intelligence (genAI) postpartum chatbot","Participants randomly assigned to the chatbot intervention will be provided a URL to a secure, HIPAA-compliant web application hosted by UC San Diego (https:\u002F\u002Fknolohealth.org\u002F). This application features a generative AI-powered chatbot designed to deliver postpartum pelvic floor education and support. The chatbot is available for a 4-week period following enrollment and can be accessed at any time during that window.\n\nThe chatbot's educational content is grounded in reputable, evidence-based resources, including national and international urogynecology patient education materials, as well as postpartum recovery guidelines. Participants can interact with the chatbot to ask questions and will receive tailored educational responses related to pelvic floor health.\n\nNo additional in-person study visits are required for the intervention. Chatbot usage data (e.g., frequency, timing and content of chatbot interactions) will be collected to assess engagement and user needs.",[14],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Standard of Care (SOC)","Access to the same postpartum care that participants would receive if they did not participate in the study.",[14,9],[9,29],"Routine postpartum care",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Alexandra C Nutaitis, DO","CONTACT","858-657-7344","anutaitis@health.ucsd.edu",{"name":37,"role":33,"phone":38,"phoneExt":23,"email":39},"Cecile Ferrando, MD, MPH","(858) 657-1238","cferrando@health.ucsd.edu",[41],{"facility":42,"status":23,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of California San Diego","La Jolla","California","92093","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-117.2742,32.84727,{"lat":52,"lon":51},[55],{"name":37,"role":56,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Cecile Ferrando","Professor OBGYN & Reproductive Sciences","100610142","postpartum-education-via-artificial-intelligence-for-recovery-and-loneliness-a-randomized-controlled-trial-100610142",false,"NCT07223736","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial","Postpartum Education Via Artificial Intelligence for Recovery and Loneliness (PEARL): A Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\n1. Has the capacity to provide informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Postpartum persons, aged \\>18 years old\n4. Primiparous\n5. Vaginal or cesarean delivery\n6. English Speaking\n7. Internet access and proficiency of internet access\n8. Access to a smartphone\n9. Postpartum 2-6 weeks\n\nExclusion Criteria:\n\n1. Multiparous\n2. Major neonatal anomaly\n3. Delivery \\\u003C 34 weeks gestational age\n4. Intrauterine fetal demise (IUFD)\n5. Enrollment in any interfering studies\n6. Unanticipated NICU admission\n7. Discharge home without live baby\n8. Surrogates\u002Fgestational carrier\n9. Birthing individuals with baby placed for adoption\n10. Currently pregnant\n11. Psychiatric history requiring psychiatric hospitalization prior to delivery\n12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and\u002For treatment team","FEMALE","18 Years",{"count":71,"type":72},130,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth.\n\nThe main questions this study aims to answer are:\n\n* Does using the chatbot improve postpartum pelvic floor health knowledge?\n* Does using the chatbot help reduce feelings of loneliness during the postpartum period?\n* Does using the chatbot impact pelvic floor symptoms?\n\nResearchers will compare standard postpartum care to standard care plus the chatbot.\n\nParticipants will:\n\nBe assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot.\n\nIf in the chatbot group, participants will receive education and support via the chatbot over a 4-week period.\n\nBoth groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress.\n\nThe chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.",[78,79,80,81,82,83,84,85,86],"Pelvic Floor Disorder","Loneliness","Postpartum","Mental Health","Depression","Peritraumatic Distress","Women","Artificial Intelligence (AI)","Chatbot",[88,89,90,91,92,93,94,95,96,97,98,99],"loneliness","postpartum","pelvic floor disorder","mental health","depression","peritraumatic distress","artificial intelligence","AI","chatbot","LLM","women","large language model","NOT_YET_RECRUITING","2025-10-31",{"date":103,"type":104},"2025-11-03","ACTUAL",{"date":106,"type":72},"2025-11-10",{"date":108,"type":72},"2026-11-01",{"name":5,"class":6},1]