Well-Being, PsychologicalPAS-EDU-NLANCT06368583
The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia
An observational study of Well-Being, Psychological, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Interview
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2024to 6 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who deliver vaginally with neuraxial analgesia at Mount Sinai Hospital.
Who may be able to join
- aged 18 years and older
- ASA Physical Classification Score II or III
- Patients having vaginal delivery and LEA
- Singleton or Multiple pregnancy
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Well-Being, Psychological
- Being tested
- Interview
- Keywords
- patient experience, neuraxial analgesia, labour epidural
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Also called Interview questions
Patients will be interviewed by the research team to learn about their experience of vaginal delivery with neuraxial analgesia
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery with neuraxial analgesia | Patients who have a vaginal delivery with neuraxial analgesia. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start26 Jun 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Nabecker, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368583
- Sponsor's protocol ID
- 24-05
- Acronym
- PAS-EDU-NLA
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06368583
- Acronym / sponsor ID
- PAS-EDU-NLA / 24-05
- Conditions
- Well-Being, Psychological
- Keywords
- patient experience, neuraxial analgesia, labour epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery with neuraxial analgesia | – | Other: InterviewPatients who have a vaginal delivery with neuraxial analgesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who deliver vaginally with neuraxial analgesia at Mount Sinai Hospital.
Key inclusion criteria (4 listed)
- aged 18 years and older
- ASA Physical Classification Score II or III
- Patients having vaginal delivery and LEA
- Singleton or Multiple pregnancy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAlso: Interview questionsPatients will be interviewed by the research team to learn about their experience of vaginal delivery with neuraxial analgesia | Other | Vaginal delivery with neuraxial analgesia |
Primary outcome
Patient questionnaire
Time frame: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
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.
Patient interview
Time frame: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Nabecker principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-Being, Psychological, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient questionnaire (time frame: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.