Recruiting

Intraoperative Comfort Assessment Tool

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT07867106

Conditions

Discomfort

Psychological Well Being

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Interview

Study Details

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

Study ID

NCT07867106

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria

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

Exclusion Criteria:

\-

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Interview

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

Primary outcome measure

  • Patient interview [ Time Frame: 36 hours ]

Central Contacts and Locations

Central contacts

Fernanda Septimio Lanza Oliveira, MD

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

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Fernanda Septimio Lanza Oliveira, MD

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

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Oct 9, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.