Well-Being, PsychologicalPAS-EDU-RCDNCT06368570
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery
An observational study of Well-Being, Psychological, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. 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
- 25 Apr 2024to 19 Jun 2024
- 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 by scheduled cesarean section with neuraxial anesthesia at Mount Sinai Hospital.
Who may be able to join
- aged 18 years or older
- ASA Physical Classification Score II or III
- elective CD (i.e. scheduled between 7am - 5pm) as per institutional standards (see below)
- patients who underwent the additional procedure of tubal ligation, salpingectomy or myomectomy (of uterine fibroid <4cm) at the time of CD will be included as these are considered minor additional procedures
Who cannot join
- under 18 years of age
- unable to answer questions due to a language barrier or their mental state
- BMI at the time of delivery that falls in the super-morbidly obese category (BMI > 55m-2)
- Patients who have underwent preterm delivery (under 37 weeks gestation), had a multiple gestation pregnancy or if there was presence of a significant fetal anomaly
- Anesthetic technique that significantly deviates from the institutional standards (see below*) including patients who underwent elective CD under epidural or dural puncture epidural (DPE) technique
- Performance of myomectomy with fibroid size >4cm at the time of CD
- Patients who underwent emergent CD as well as those who had contraindicated or failed neuraxial anesthesia and required general anesthesia for or during their CD will also be excluded.
- Institutional standards: spinal or combined spinal and epidural (CSE) with the standard dose of 1.8mL heavy bupivacaine 0.75% combined with intrathecal morphine 100-150 micrograms and fentanyl 10-15 micrograms. Administration of crystalloid co-loading at 10-15mL/kg following establishment of neuraxial and vasopressors (phenylephrine, norepinephrine or ephedrine) to maintain systolic blood pressure at baseline. Routine administration of acetaminophen (PR), ketorolac (IV), dexamethasone and ondansetron, unless contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery to Inform Anesthetic Practice. a Prospective Patient-centred Multidisciplinary Mixed-method (PAS-EDU-RCD)
This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.
Patients who have undergone a routine CD will be approached the day following their 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 obstetricians, anesthesiologists and nurses with the goal 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 elective CD.
Read the detailed description
Elective CD is predominantly performed under neuraxial anesthesia that allows patients to be awake and able to experience childbirth along their support person. There is a high maternal satisfaction associated with being able to experience childbirth, however there is also high incidence of anxiety associated with being aware of the surgical procedure that is occurring while under neuraxial anesthesia. There are a limited number of studies that have explored the experience of the patient while undergoing elective CD under neuraxial anesthesia and even fewer that have focused on the patient's perspective, that is used to educate health care professionals on how to improve the quality of anesthesia care during elective CD. This study aims to embrace the patient perspective to guide quality improvement in the delivery of elective CD.
- Conditions
- Well-Being, Psychological
- Being tested
- Interview
- Keywords
- cesarean delivery, patient experience, neuraxial anesthesia
- 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 Cesarean delivery with neuraxial anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Cesarean delivery with neuraxial anesthesia. | Patients who have a scheduled cesarean delivery with neuraxial anesthesia. 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 cesarean delivery with neuraxial anesthesia, 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 start25 Apr 2024
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
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, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368570
- Sponsor's protocol ID
- 24-04
- Acronym
- PAS-EDU-RCD
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2024
- Last updated
- 26 Feb 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 26 Feb 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' Experience During Routine Cesarean Delivery to Inform Anesthetic Practice. a Prospective Patient-centred Multidisciplinary Mixed-method (PAS-EDU-RCD)
- ClinicalTrials.gov ID
- NCT06368570
- Acronym / sponsor ID
- PAS-EDU-RCD / 24-04
- Conditions
- Well-Being, Psychological
- Keywords
- cesarean delivery, patient experience, neuraxial anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (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.
This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.
Patients who have undergone a routine CD will be approached the day following their 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 obstetricians, anesthesiologists and nurses with the goal 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 elective CD.
Detailed description
Elective CD is predominantly performed under neuraxial anesthesia that allows patients to be awake and able to experience childbirth along their support person. There is a high maternal satisfaction associated with being able to experience childbirth, however there is also high incidence of anxiety associated with being aware of the surgical procedure that is occurring while under neuraxial anesthesia. There are a limited number of studies that have explored the experience of the patient while undergoing elective CD under neuraxial anesthesia and even fewer that have focused on the patient's perspective, that is used to educate health care professionals on how to improve the quality of anesthesia care during elective CD. This study aims to embrace the patient perspective to guide quality improvement in the delivery of elective CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean delivery with neuraxial anesthesia. | – | Other: InterviewPatients who have a scheduled cesarean delivery with neuraxial anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who deliver by scheduled cesarean section with neuraxial anesthesia at Mount Sinai Hospital.
Key inclusion criteria (4 listed)
- aged 18 years or older
- ASA Physical Classification Score II or III
- elective CD (i.e. scheduled between 7am - 5pm) as per institutional standards (see below)
- patients who underwent the additional procedure of tubal ligation, salpingectomy or myomectomy (of uterine fibroid <4cm) at the time of CD will be included as these are considered minor additional procedures
Key exclusion criteria (8 listed)
- under 18 years of age
- unable to answer questions due to a language barrier or their mental state
- BMI at the time of delivery that falls in the super-morbidly obese category (BMI > 55m-2)
- Patients who have underwent preterm delivery (under 37 weeks gestation), had a multiple gestation pregnancy or if there was presence of a significant fetal anomaly
- Anesthetic technique that significantly deviates from the institutional standards (see below*) including patients who underwent elective CD under epidural or dural puncture epidural (DPE) technique
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 Cesarean delivery with neuraxial anesthetic | Other | Cesarean delivery with neuraxial anesthesia. |
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 cesarean delivery with neuraxial anesthesia, 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 26 Feb 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, MD 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 8 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 26 Feb 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 26 Feb 2025.