[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619157":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":45,"armGroups":46,"interventions":52,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":99,"collaborators":40,"id":102,"slug":40,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":40,"enrollmentInfo":112,"targetDuration":40,"studyType":115,"phases":40,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":125,"whyStopped":40,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of British Columbia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of intraoperative sensory stimuli perceived as unacceptable","Proportion of participants who report experiencing any intraoperative sensory stimulus that they subjectively self-report as unacceptable.","From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.",[14,17,20,23,27,30,33,37],{"measure":15,"description":16,"timeFrame":12},"Qualitative description of unacceptable sensory stimuli","Thematic categorization of participant responses",{"measure":18,"description":19,"timeFrame":12},"Severity of intraoperative sensory stimuli","Sensation intensity rated using a 0-10 visual analog scale (VAS) at each intraoperative assessment time point.",{"measure":21,"description":22,"timeFrame":12},"Total intraoperative supplemental IV analgesia received","Total dose(s) of supplemental IV analgesic medications administered intraoperatively, abstracted from the medical record\u002Fanesthesia record.",{"measure":24,"description":25,"timeFrame":26},"PTSD symptoms over time","PTSD Checklist for DSM-5 (PCL-5) score measured longitudinally.","From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.",{"measure":28,"description":29,"timeFrame":26},"Depressive symptoms over time","Edinburgh Postnatal Depression Scale (EPDS) score measured longitudinally.",{"measure":31,"description":32,"timeFrame":26},"Peritraumatic distress over time","Peritraumatic Distress Inventory (PDI) score measured longitudinally.",{"measure":34,"description":35,"timeFrame":36},"Postoperative pain intensity (NRS)","0-10 Numerical Rating Scale (NRS) pain scores collected during the first 48 hours of admission, per clinical charting.","From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.",{"measure":38,"description":39,"timeFrame":36},"In-hospital opioid requirement (MME)","Total opioid dose administered from end of surgery until hospital discharge, converted to oral morphine milligram equivalents (MME).",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"COHORT","PROSPECTIVE","Cesarean delivery is common and neuraxial anesthesia is the standard technique; however, a meaningful proportion of patients experience intraoperative pain or distressing sensations. Existing research often relies on retrospective recall, surrogate markers (e.g., medication use), and variable definitions of intraoperative pain, with limited prospective characterization of the sensory experiences that patients perceive and whether participants interpret them as painful or otherwise unacceptable.\n\nPIONEER is a prospective, longitudinal cohort study enrolling healthy pregnant patients undergoing elective cesarean delivery at BC Women's Hospital. The primary objective is to estimate the incidence of intraoperative sensory stimuli that are self-reported as unacceptable (i.e., sensations the participant reports as unacceptable and needing treatment). Intraoperative data will be collected at six defined surgical milestones from block confirmation to skin closure via short patient questions. Postoperative and longitudinal follow-up will assess postpartum distress, depression, and PTSD symptoms. Clinical care is not directed by the study; anesthetic and surgical management remains at the discretion of the treating team.","Healthy pregnant patients ≥36 weeks gestational age undergoing elective cesarean delivery under neuraxial anesthesia at BC Women's Hospital",[47],{"label":48,"type":40,"description":49,"interventionNames":50},"Single cohort","Healthy patient undergoing elective cesarean delivery under neuraxial anesthesia",[51],"Other: Standardized intraoperative and postoperative patient-reported assessments",[53],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"Standardized intraoperative and postoperative patient-reported assessments","Brief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum.",[48],[58],{"name":59,"affiliation":60,"role":61},"Juliana Kruthof, MD, MSc, FRCPC","Department of Anesthesia BC Women's Hospital","PRINCIPAL_INVESTIGATOR",[63],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","604-875-2424","6335","juliana.barrera@cw.bc.ca",[69],{"facility":70,"status":40,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"BC Women's Hospital","Vancouver","British Columbia","V6H3N1","Canada","CA",{"type":77,"coordinates":78},"Point",[79,80],-123.11934,49.24966,{"lat":80,"lon":79},[83,85,88,91,92,94,96,98],{"name":59,"role":64,"phone":84,"phoneExt":66,"email":67},"604-875-2158",{"name":86,"role":64,"phone":84,"phoneExt":66,"email":87},"Simon Massey, FRCA, FRCPC","simon.massey@cw.bc.ca",{"name":89,"role":90,"phone":40,"phoneExt":40,"email":40},"Roanne Preston, MD, FRCPC","SUB_INVESTIGATOR",{"name":59,"role":61,"phone":40,"phoneExt":40,"email":40},{"name":93,"role":90,"phone":40,"phoneExt":40,"email":40},"William Shippam, MBChB, FRCA, FRCPC",{"name":95,"role":90,"phone":40,"phoneExt":40,"email":40},"Kathryn Clark, MD, FRCPC",{"name":97,"role":90,"phone":40,"phoneExt":40,"email":40},"Katherine M Seligman, MD, FRCPC D.ABA",{"name":86,"role":90,"phone":40,"phoneExt":40,"email":40},{"type":61,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Juliana Barrera","Clinical Asisstant Professor","100619157",false,"NCT07340970","Sensory Stimuli During Cesarean Delivery","Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER)","PIONEER","Inclusion Criteria:\n\n* Healthy pregnant patients ≥36 weeks gestational age\n* ASA Physical Status Class 2-3\n* Elective cesarean delivery\n* Age ≥19 years\n* English-speaking\n\nExclusion Criteria:\n\n* Known history of chronic pain or pain disorders\n* Currently taking medications with analgesic properties\n* Known history of neurological conditions that may impair normal sensation\n* Cesarean delivery requiring epidural top-up or de novo general anesthesia",true,"FEMALE","19 Years",{"count":113,"type":114},310,"ESTIMATED","OBSERVATIONAL","This study will follow people having a planned cesarean birth with a spinal or combined spinal-epidural anesthetic. The investigators will ask what kinds of sensations participants feel during the operation, how often these happen, and whether any of the sensations feel as unacceptable or too uncomfortable.\n\nParticipants will be asked a few short questions at six set times during the surgery. Participants will also complete short questionnaires before surgery and again after birth (up to 6 months) to help us understand mood, stress, and overall wellbeing.",[118],"Intraoperative Pain",[120,121,122,123,124],"cesarean delivery","neuraxial anesthesia","intraoperative pain","intraoperative sensation","peritraumatic distress","NOT_YET_RECRUITING","2026-04-11",{"date":128,"type":129},"2026-04-14","ACTUAL",{"date":131,"type":114},"2026-05-11",{"date":133,"type":114},"2027-09-30",{"name":5,"class":6},1]