Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia

NCT07867106 | Recruiting

• 1 other identifier: 26-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Discomfort; Psychological Well Being

Keywords

cesarean delivery; patient experience; neuraxial anesthesia; epidural; spinal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Interview

Interventions

Interview OTHER

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

Patients who have a Cesarean delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital

You may qualify if:

• Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia
• Able to communicate in English.

You may not qualify if:

• Severe maternal illness preventing participation
• Cognitive impairment or inability to complete study procedures
• \> 36 hours since cesarean delivery

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fernanda Septimio Lanza Oliveira, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Septimio Lanza Oliveira, MD

CONTACT

416-586-4800; Fernanda.Oliveira@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)