Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia (ICAT)
Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Fernanda Septimio Lanza Oliveira, MD
- Telefonnummer: 5270 416-586-4800
- E-post: Fernanda.Oliveira@sinaihealth.ca
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G1X5
- Rekrytering
- Mount Sinai Hospital
-
Kontakt:
- Kristi Downey, MSc
- Telefonnummer: 2366 416-586-4800
- E-post: kristi.downey@uhn.ca
-
Underutredare:
- Ronald George, MD
-
Underutredare:
- Naveed Siddiqui, MD
-
Kontakt:
- Fernanda Septimio Lanza Oliveira, MD
- Telefonnummer: 5270 416-586-4800
- E-post: Fernanda.Oliveira@sinaihealth.ca
-
Underutredare:
- Margarita Blajeva, MD
-
Underutredare:
- Miki Peer, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient interview
Tidsram: 36 hours
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Fernanda Septimio Lanza Oliveira, MD, MOUNT SINAI HOSPITAL
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-02
Plan för individuella deltagardata (IPD)
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