Clinical trial NCT06368583: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia
Official title: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia. A Prospective Patient-centered Multidisciplinary Quality Improvement Study. (PAS-EDU-NLA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Well-Being, Psychological
Keywords: patient experience
neuraxial analgesia
labour epidural
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who deliver vaginally with neuraxial analgesia at Mount Sinai Hospital.

Brief summary: During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.

Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery.

Detailed description: About 85-90% of parturient receive labour epidural as a method of pain management for labour and delivery. Various factors play a role in requesting an epidural. Proper patient counseling and education before Labour Epidural Analgesia (LEA) alleviates patient's anxiety and also ensures safety. There are a limited number of studies that have explored the experience of the patient while undergoing LEA and labour and delivery, and even fewer that have focused on the patients' perspective that is used to educate health care professionals on how to improve the quality of anesthesia care during LEA. This study embraces the patient perspective to guide quality improvement in labour and delivery.

Eligibility criteria: Inclusion Criteria:

* aged 18 years and older
* ASA Physical Classification Score II or III
* Patients having vaginal delivery and LEA
* Singleton or Multiple pregnancy

Exclusion Criteria:

* under 18 years of age
* unwilling to provide written informed consent, or unable to follow the questions due to their mental state or language barriers.
* Patients who delivered via Cesarean section
* TOP/ IUFDs
* requiring instrumental deliveries- for example forceps or vacuum
* requiring to go to the OR postpartum for PPH or other reasons
* BMI at the time of delivery that falls in the super-morbidly obese category (BMI \>55kg/m2)
* Preterm delivery (under 37 weeks of gestation)
* Patients who had inadvertent Dural Puncture during epidural placement
* Patients who had contraindicated or failed epidural anesthesia and required IV PCA for or during their delivery will also be excluded

Primary outcomes:
measure: Patient questionnaire
timeFrame: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
measure: Patient interview
timeFrame: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Sabine Nabecker
role: PRINCIPAL_INVESTIGATOR
References: