The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia

NCT06368583 | Completed

• 1 other identifier: 24-05
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-Being, Psychological

Keywords

patient experience; neuraxial analgesia; labour epidural

Outcome Measures

Primary Outcomes (2)

• Patient questionnaire

  Patients will be asked to rate their experience of having a vaginal delivery with neuraxial analgesia, in terms of satisfaction and their experience with any discomfort. Some questions are yes/no, some are on a scale from 1-10, where 1 = not at all and 10 = totally agree, and some are open-ended. The questionnaire will take approximately 10 minutes to complete.

  Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

• 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.

  Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

Study Arms (1)

Vaginal delivery with neuraxial analgesia

Patients who have a vaginal delivery with neuraxial analgesia.

Other: Interview

Interventions

Interview OTHER

Patients will be interviewed by the research team to learn about their experience of vaginal delivery with neuraxial analgesia

Also known as: Interview questions

Vaginal delivery with neuraxial analgesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver vaginally with neuraxial analgesia at Mount Sinai Hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sabine Nabecker

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: June 26, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)