Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Severe maternal illness preventing participation

Cognitive impairment or inability to complete study procedures

> 36 hours since cesarean delivery

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Interview

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients who have a Cesarean delivery1 intervention

Trial outcomes

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.

Time frame
36 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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