An observational study in Discomfort and Psychological Well Being, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · 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.
Right 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.
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).
1,045 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 146 observational studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
Inclusion Criteria:
Exclusion Criteria
Exclusion Criteria:
-
Patients who had Cesarean delivery, who experienced intraoperative pain or discomfort, and those who required intraoperative intravenous analgesic or sedative supplementation.
Other: Interview
Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended.
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.
Time frame: 36 hours
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital →