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Trials / Completed

CompletedNCT06589687

The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice

The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice. A Prospective Patient-centred Multidisciplinary Mixed-method. (PAS-EDU-uCD-NA)

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

This study aims to explore the patients' and providers' perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery (CD) under neuraxial anesthesia (NA). The consideration of patients' concerns, preferences, expectations, and suggestions may lead to enhanced patient satisfaction, compliance, and quality of care that future patients receive during unexpected CD under NA. The investigators will possibly be able to identify gaps in procedural performance that warrant further investigation during the second phase of this study which will contribute to improvement of overall patient care. During the third phase, educational material will be generated from patient insights and will be distributed to the Department of Anesthesia, Department of Obstetrics and Gynaecology, Labour and Delivery Nurses and team of Anesthesia Assistants and Respiratory Therapists.

Detailed description

Cesarean delivery (CD) is a surgical procedure that allows for birth of a neonate through a laparotomy and hysterotomy and is the most common surgical procedure performed worldwide with 21% of all childbirths occurring via CD. Neuraxial anesthesia (NA) is the preferred anesthetic for CD because it has a better safety profile, avoids airway management, decreases blood loss, improves postoperative analgesia, and decreases neonatal drug exposure compared with general anesthesia. NA allows the patient and partner to experience the delivery, enhancing parent-baby bonding, but has many well-described risks, including hypotension leading to nausea, shivering, post-dural puncture headache, nerve injury, and failure to achieve satisfactory anesthesia. If a CD is needed in a parturient with an existing labour epidural analgesia, it is common practice to convert or 'top-up' the epidural catheter, with the aim of initiating surgical anesthesia by injecting more concentrated local anesthetic (LA) solution, normally combined with a lipid-soluble opioid. Patients' greatest concern during and after CD is pain. Childbirth is a profound experience with 1/3 of patients experiencing a highly stressful and potentially traumatic childbirth. A birthing parent's experience during a planned CD versus an unexpected CD (uCD) can play a role in the development of post-traumatic stress disorder (PTSD). Childbirth-related PTSD is estimated to affect 5-6% of all postpartum women. With CD representing 1/3 of all North American deliveries annually, uCDs will contribute to an increased risk of PTSD and post-partum depression (PPD) symptoms. Given the suffering associated with PPD and that women experiencing PPD incur greater health care costs, understanding the association between CD and associated traumatic birth experiences may help guide interventions to address both the psychosocial impact on families and the economic impacts on health care. The concept of "patients as educators" is new to the practice of anesthesia and aims to embrace the patient perspective to guide quality improvement initiatives. This study will explore patients' perception of their experience with uCD under neuraxial anesthesia (uCD-NA) and aim to provide insight into patients' feelings, concerns and expectations after an unscheduled experience for childbirth. By adding the providers' perspective on the topic of childbirth via uCD-NA, the investigators will be able to explore differences and similarities in opinions, thoughts, feelings and concerns as well as wishes for their care between patients and their providers. Thus, the study will also aim to explore the perspective of anesthesiologists, anesthesia assistants/respiratory therapists, obstetricians and registered nurses.

Conditions

Interventions

TypeNameDescription
OTHERInterviewPatients will be interviewed by the research team to learn about their experience of Cesarean delivery under neuraxial anesthetic.

Timeline

Start date
2025-01-07
Primary completion
2025-06-19
Completion
2025-06-19
First posted
2024-09-19
Last updated
2026-04-01

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06589687. Inclusion in this directory is not an endorsement.