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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Fernanda Septimio Lanza Oliveira, MD
- Telefonnummer: 5270 416-586-4800
- E-mail: Fernanda.Oliveira@sinaihealth.ca
Studiesteder
-
-
Ontario
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Toronto, Ontario, Canada, M5G1X5
- Rekruttering
- Mount Sinai Hospital
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Kontakt:
- Kristi Downey, MSc
- Telefonnummer: 2366 416-586-4800
- E-mail: kristi.downey@uhn.ca
-
Underforsker:
- Ronald George, MD
-
Underforsker:
- Naveed Siddiqui, MD
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Kontakt:
- Fernanda Septimio Lanza Oliveira, MD
- Telefonnummer: 5270 416-586-4800
- E-mail: Fernanda.Oliveira@sinaihealth.ca
-
Underforsker:
- Margarita Blajeva, MD
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Underforsker:
- Miki Peer, PhD
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient interview
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Fernanda Septimio Lanza Oliveira, MD, MOUNT SINAI HOSPITAL
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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