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RECRUITING
NCT07867106

Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-10

Completion Date

2026-12

Last Updated

2026-10-09

Healthy Volunteers

Yes

Interventions

OTHER

Interview

Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended.

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada