[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659745":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":25,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":71,"collaborators":13,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":13,"enrollmentInfo":84,"targetDuration":13,"studyType":87,"phases":13,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Samuel Lunenfeld Research Institute, Mount Sinai Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Patient interview","Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete.","36 hours",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Despite increasing emphasis on patient-centered care in obstetric anesthesia, there remains no validated, procedure-specific instrument designed to capture intraoperative discomfort during cesarean delivery under neuraxial anesthesia. Existing tools either focus exclusively on postoperative pain or assess satisfaction retrospectively, limiting their ability to inform real-time intraoperative management and quality improvement efforts. This study will therefore employ qualitative interviews to elicit patient-reported intraoperative experiences of discomfort to inform development of a novel patient-reported outcome measure of intraoperative discomfort, tentatively called The Intraoperative Comfort Assessment Tool (ICAT).","Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital",[20],{"label":21,"type":13,"description":22,"interventionNames":23},"Patients who have a Cesarean delivery","Patients who had Cesarean delivery, who experienced intraoperative pain or discomfort, and those who required intraoperative intravenous analgesic or sedative supplementation.",[24],"Other: Interview",[26],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":13},"Interview","Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended.",[21],[31],{"name":32,"affiliation":33,"role":34},"Fernanda Septimio Lanza Oliveira, MD","MOUNT SINAI HOSPITAL","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","416-586-4800","5270","Fernanda.Oliveira@sinaihealth.ca",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Mount Sinai Hospital","RECRUITING","Toronto","Ontario","M5G1X5","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.39864,43.70643,{"lat":54,"lon":53},[57,58,62,65,67,69],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":59,"role":37,"phone":38,"phoneExt":60,"email":61},"Kristi Downey, MSc","2366","kristi.downey@uhn.ca",{"name":63,"role":64,"phone":13,"phoneExt":13,"email":13},"Margarita Blajeva, MD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":13,"phoneExt":13,"email":13},"Naveed Siddiqui, MD",{"name":68,"role":64,"phone":13,"phoneExt":13,"email":13},"Miki Peer, PhD",{"name":70,"role":64,"phone":13,"phoneExt":13,"email":13},"Ronald George, MD",{"type":72,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659745","patient-experiences-of-intraoperative-discomfort-during-cesarean-delivery-under-neuraxial-anesthesia-100659745",false,"NCT07867106","Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia","Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation","ICAT","Inclusion Criteria:\n\n* Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia\n* Able to communicate in English.\n\nExclusion Criteria\n\n* Severe maternal illness preventing participation\n* Cognitive impairment or inability to complete study procedures\n* \\> 36 hours since cesarean delivery\n\nExclusion Criteria:\n\n\\-",true,"FEMALE","18 Years",{"count":85,"type":86},30,"ESTIMATED","OBSERVATIONAL","During a cesarean delivery done under spinal or epidural anesthesia, many patients notice sensations they weren't expecting things like pressure, pulling, tugging, or nausea even though the anesthesia blocks pain. These sensations can be distressing, and research suggests that difficult experiences during surgery may raise the risk of anxiety or post-traumatic stress after childbirth.\n\nRight now, there's no dedicated tool for asking patients about these experiences during the procedure, which makes it hard for care teams to recognize, measure, or address them. This study is the first step toward building such a tool, called the Intraoperative Comfort Assessment Tool (ICAT). Researchers will interview 20 to 30 patients who recently had a cesarean delivery under spinal or epidural anesthesia at Mount Sinai Hospital in Toronto, asking them, in their own words, about what they felt during surgery. The interviews explore what different sensations felt like, how patients tell the difference between pressure, discomfort, and pain, and which symptoms bothered them most. By listening closely to how patients naturally describe their experiences, the team will identify common words and themes to build a more accurate, patient-centered questionnaire. Eventually, this tool could help anesthesiologists notice and respond to discomfort in real time during surgery, and give researchers a standard way to measure and improve the childbirth experience.",[90,91],"Discomfort","Psychological Well Being",[93,94,95,96,97],"cesarean delivery","patient experience","neuraxial anesthesia","epidural","spinal","2026-10-05",{"date":100,"type":101},"2026-10-09","ACTUAL",{"date":103,"type":86},"2026-10",{"date":105,"type":86},"2026-12",{"name":5,"class":6},1]