DiscomfortICATNCT07867106
Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia
An observational study of Discomfort and Psychological Well Being, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
During a cesarean delivery done under spinal or epidural anesthesia, many patients notice sensations they weren't expecting things like pressure, pulling, tugging, or nausea even though the anesthesia blocks pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Discomfort, Psychological Well Being
- What is being tested?
- Interview
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
Who may be able to join
- Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia
- Able to communicate in English.
Who cannot join
- Severe maternal illness preventing participation
- Cognitive impairment or inability to complete study procedures
- > 36 hours since cesarean delivery
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Fernanda Septimio Lanza Oliveira, MD, 416-586-4800 ext. 5270, Fernanda.Oliveira@sinaihealth.ca
Kristi Downey, MSc, 416-586-4800 ext. 2366, kristi.downey@uhn.ca
About this study
Official title: Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation
During a cesarean delivery done under spinal or epidural anesthesia, many patients notice sensations they weren't expecting things like pressure, pulling, tugging, or nausea even though the anesthesia blocks pain. These sensations can be distressing, and research suggests that difficult experiences during surgery may raise the risk of anxiety or post-traumatic stress after childbirth.
Right now, there's no dedicated tool for asking patients about these experiences during the procedure, which makes it hard for care teams to recognize, measure, or address them. This study is the first step toward building such a tool, called the Intraoperative Comfort Assessment Tool (ICAT). Researchers will interview 20 to 30 patients who recently had a cesarean delivery under spinal or epidural anesthesia at Mount Sinai Hospital in Toronto, asking them, in their own words, about what they felt during surgery. The interviews explore what different sensations felt like, how patients tell the difference between pressure, discomfort, and pain, and which symptoms bothered them most. By listening closely to how patients naturally describe their experiences, the team will identify common words and themes to build a more accurate, patient-centered questionnaire. Eventually, this tool could help anesthesiologists notice and respond to discomfort in real time during surgery, and give researchers a standard way to measure and improve the childbirth experience.
Read the detailed description
Despite increasing emphasis on patient-centered care in obstetric anesthesia, there remains no validated, procedure-specific instrument designed to capture intraoperative discomfort during cesarean delivery under neuraxial anesthesia. Existing tools either focus exclusively on postoperative pain or assess satisfaction retrospectively, limiting their ability to inform real-time intraoperative management and quality improvement efforts. This study will therefore employ qualitative interviews to elicit patient-reported intraoperative experiences of discomfort to inform development of a novel patient-reported outcome measure of intraoperative discomfort, tentatively called The Intraoperative Comfort Assessment Tool (ICAT).
- Conditions
- Discomfort, Psychological Well Being
- Being tested
- Interview
- Keywords
- cesarean delivery, patient experience, neuraxial anesthesia, epidural, spinal
- 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
Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have a Cesarean delivery | Patients who had Cesarean delivery, who experienced intraoperative pain or discomfort, and those who required intraoperative intravenous analgesic or sedative supplementation. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiscomfortStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernanda Septimio Lanza Oliveira, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867106
- Sponsor's protocol ID
- 26-02
- Acronym
- ICAT
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation
- ClinicalTrials.gov ID
- NCT07867106
- Acronym / sponsor ID
- ICAT / 26-02
- Conditions
- Discomfort, Psychological Well Being
- Keywords
- cesarean delivery, patient experience, neuraxial anesthesia, epidural, spinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (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 a cesarean delivery done under spinal or epidural anesthesia, many patients notice sensations they weren't expecting things like pressure, pulling, tugging, or nausea even though the anesthesia blocks pain. These sensations can be distressing, and research suggests that difficult experiences during surgery may raise the risk of anxiety or post-traumatic stress after childbirth.
Right now, there's no dedicated tool for asking patients about these experiences during the procedure, which makes it hard for care teams to recognize, measure, or address them. This study is the first step toward building such a tool, called the Intraoperative Comfort Assessment Tool (ICAT). Researchers will interview 20 to 30 patients who recently had a cesarean delivery under spinal or epidural anesthesia at Mount Sinai Hospital in Toronto, asking them, in their own words, about what they felt during surgery. The interviews explore what different sensations felt like, how patients tell the difference between pressure, discomfort, and pain, and which symptoms bothered them most. By listening closely to how patients naturally describe their experiences, the team will identify common words and themes to build a more accurate, patient-centered questionnaire. Eventually, this tool could help anesthesiologists notice and respond to discomfort in real time during surgery, and give researchers a standard way to measure and improve the childbirth experience.
Detailed description
Despite increasing emphasis on patient-centered care in obstetric anesthesia, there remains no validated, procedure-specific instrument designed to capture intraoperative discomfort during cesarean delivery under neuraxial anesthesia. Existing tools either focus exclusively on postoperative pain or assess satisfaction retrospectively, limiting their ability to inform real-time intraoperative management and quality improvement efforts. This study will therefore employ qualitative interviews to elicit patient-reported intraoperative experiences of discomfort to inform development of a novel patient-reported outcome measure of intraoperative discomfort, tentatively called The Intraoperative Comfort Assessment Tool (ICAT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have a Cesarean delivery | – | Other: InterviewPatients who had Cesarean delivery, who experienced intraoperative pain or discomfort, and those who required intraoperative intravenous analgesic or sedative supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
Key inclusion criteria (2 listed)
- Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia
- Able to communicate in English.
Key exclusion criteria (4 listed)
- Severe maternal illness preventing participation
- Cognitive impairment or inability to complete study procedures
- > 36 hours since cesarean delivery
- -
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 |
|---|---|---|
| InterviewPatients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended. | Other | Patients who have a Cesarean delivery |
Primary outcome
Patient interview
Time frame: 36 hours
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
Fernanda Septimio Lanza Oliveira, 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 Discomfort and Psychological Well Being, 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Septimio Lanza Oliveira, MD (416-586-4800 ext. 5270, Fernanda.Oliveira@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient interview (time frame: 36 hours). 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 9 Oct 2026.