[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619157":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":62,"collaborators":65,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Elective cesarean delivery under neuraxial anesthesia",null,"Adults undergoing a planned (elective) cesarean delivery under single-shot spinal or combined spinal-epidural anesthesia at a participating tertiary-care obstetric center. All enrolled participants form a single prospective cohort and undergo the same study assessments: standardized self-report of intraoperative sensory experience at six predefined surgical timepoints (including, at each timepoint, whether a sensation is felt, a verbatim description of the sensation, a request for intervention if any, an intensity rating, and the anatomical location of the sensation), followed by longitudinal psychological assessment from a preoperative baseline through 6 months postpartum. Participants are not assigned to any intervention or exposure by the investigators; all anesthetic and surgical care is provided by the clinical team according to institutional standards.",[13],"Other: Patient-initiated request for pharmacological intervention during cesarean delivery",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Patient-initiated request for pharmacological intervention during cesarean delivery","The exposure of interest is the participant's own request, made during cesarean delivery, for the clinical team to provide a pharmacological intervention in response to an intraoperative sensory stimulus. At each of six predefined surgical timepoints, participants who report a sensation are asked whether they would like the team to act and, if so, whether they are requesting medication, some other action, or both. A request that includes medication constitutes the exposure. This is an observed, patient-initiated event; investigators do not assign or administer it, and all clinical management remains at the discretion of the treating team. This exposure is linked to the single study cohort (Elective cesarean delivery under neuraxial anesthesia).",[9],[20],{"name":21,"affiliation":22,"role":23},"Juliana Kruthof, MD, MSc, FRCPC","Department of Anesthesia BC Women's Hospital","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","604-875-2424","6335","juliana.barrera@cw.bc.ca",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"BC Women's Hospital","RECRUITING","Vancouver","British Columbia","V6H3N1","Canada","CA",{"type":40,"coordinates":41},"Point",[42,43],-123.11934,49.24966,{"lat":43,"lon":42},[46,48,51,54,55,57,59,61],{"name":21,"role":26,"phone":47,"phoneExt":28,"email":29},"604-875-2158",{"name":49,"role":26,"phone":47,"phoneExt":28,"email":50},"Simon Massey, FRCA, FRCPC","simon.massey@cw.bc.ca",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Roanne Preston, MD, FRCPC","SUB_INVESTIGATOR",{"name":21,"role":23,"phone":10,"phoneExt":10,"email":10},{"name":56,"role":53,"phone":10,"phoneExt":10,"email":10},"William Shippam, MBChB, FRCA, FRCPC",{"name":58,"role":53,"phone":10,"phoneExt":10,"email":10},"Kathryn Clark, MD, FRCPC",{"name":60,"role":53,"phone":10,"phoneExt":10,"email":10},"Katherine M Seligman, MD, FRCPC D.ABA",{"name":49,"role":53,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Juliana Barrera","Clinical Asisstant Professor",[66,68],{"name":67,"class":6},"Western University, Canada",{"name":69,"class":6},"University of Arkansas","100619157","sensory-stimuli-during-cesarean-delivery-100619157",false,"NCT07340970","Sensory Stimuli During Cesarean Delivery","Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER): A Multicenter Prospective Cohort Study","PIONEER-MC","Inclusion Criteria:\n\n* Pregnant and 19 years of age or older\n* Single (one) baby at 37 weeks of pregnancy or later\n* Overall health classified as American Society of Anesthesiologists (ASA) Physical Status II or III\n* Scheduled for a planned (elective) cesarean delivery using spinal anesthesia (single-shot spinal or combined spinal-epidural)\n* Able to describe sensations in their own words in one of the study's available languages\n* Willing and able to give written informed consent before any study procedures\n* Willing and able to complete online follow-up questionnaires at 6 weeks, 3 months, and 6 months after delivery\n\nExclusion Criteria:\n\n* History of a chronic pain condition (for example, fibromyalgia, chronic pelvic pain, complex regional pain syndrome, or chronic low back pain requiring ongoing treatment)\n* Regular use of opioids, gabapentinoids (gabapentin or pregabalin), or other centrally acting pain medications during the current pregnancy (occasional acetaminophen use is allowed)\n* History of a neurological condition that can affect normal sensation (for example, peripheral neuropathy, multiple sclerosis, or spinal cord injury)\n* Pregnancy with more than one baby (twins or more)\n* Cesarean delivery planned with an anesthesia method other than single-shot spinal or combined spinal-epidural (for example, topping up an existing labor epidural, or general anesthesia)\n* Known major fetal abnormality or an expected newborn complication likely to require immediate admission to the neonatal intensive care unit (NICU)\n* Known allergy or other reason the local anesthetic medications used for spinal anesthesia cannot be given\n* Active substance use disorder","FEMALE","19 Years",{"count":81,"type":82},1005,"ESTIMATED","OBSERVATIONAL","During a cesarean delivery (C-section), most patients are awake and receive spinal or epidural anesthesia to block pain from the lower body. Even when this anesthesia works well, many patients still feel sensations during surgery, such as pulling, pressure, tugging, or, in some cases, pain. In the past, studies have mostly focused on whether patients felt \"pain,\" and have often relied on patients remembering their experience afterward or on the surgical team's judgment of how the patient was doing. These approaches can miss sensations that bother the patient but are not clearly described as pain, and they may not reflect what the patient actually wanted done at the time.\n\nThis study takes a different approach. Instead of asking only about pain, the researchers will ask patients, in real time during their C-section, what they are feeling in their own words, and whether they would like the medical team to do something about it (such as giving medication). The main idea is that the patient's own request for help, rather than someone else's opinion about how severe a sensation is, should be what counts as a moment that matters.\n\nThe main purpose of the study is to find out how often patients undergoing a planned C-section ask for medication in response to a sensation they feel during surgery. The researchers will ask each patient at six specific points during the operation whether they feel any sensation, how they would describe it, and whether they would like the team to act. Patients will also rate how strong each sensation is and point to where on the body they feel it. All decisions about care will remain entirely with the patient's own medical team; the research team only records what the patient reports and what care is given.\n\nThe study is also designed to answer several related questions:\n\n* What words and descriptions do patients naturally use for the sensations they feel during a C-section?\n* How often are sensations that patients do not call \"painful\" still bothersome enough that the patient asks for medication?\n* How do patients' feelings and mental health change over the first six months after delivery, including symptoms of post-traumatic stress, depression, and birth-related distress?\n* Does a patient's anxiety before surgery affect what they feel during surgery or how likely they are to ask for help?\n\nThe main question the study is trying to answer is: How often do patients undergoing a planned cesarean delivery ask for medication because of something they feel during the operation?\n\nThe researchers' hypothesis is that this number will be higher than what earlier pain-focused studies have reported. Specifically, they expect that more than 11.5 percent of patients will ask for medication during surgery, which is greater than the rate of pain requiring extra medication found in a similar previous study. If correct, this would suggest that the true number of patients who experience moments during a C-section when they want help has been underestimated by traditional methods that focus only on pain.\n\nThis is an observational study. It does not test a new drug or change how anesthesia or surgery is performed. Instead, it carefully observes and records patients' experiences in order to better understand what patients feel during a cesarean delivery, how often they want the team to act, and how these experiences relate to their recovery and emotional well-being afterward. The goal is to use this information to improve the comfort, care, and long-term well-being of patients having a C-section.",[86],"Intraoperative Pain",[88,89,90,91,92],"cesarean delivery","neuraxial anesthesia","intraoperative pain","intraoperative sensation","peritraumatic distress","2026-07-29",{"date":95,"type":96},"2026-08-03","ACTUAL",{"date":98,"type":82},"2026-07-20",{"date":100,"type":82},"2027-09-30",{"name":5,"class":6},1]