Patient-centered tool to measure pain during cesarean delivery
Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
This project will try to create a simple tool to measure pain felt during elective cesarean delivery for people who had neuraxial (spinal/epidural) anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT07409012 on ClinicalTrials.gov |
What this trial studies
The team will review existing literature and combine clinical expert opinion with direct patient experiences to create a standardized intraoperative pain measure for cesarean delivery. Experts from multiple disciplines will take part in a structured Delphi consensus process to identify and refine key assessment items. Researchers will conduct interviews with recent cesarean patients to ensure the tool reflects patient priorities and wording. The final product aims to be a brief, patient-centered instrument usable in clinical care and research.
Who should consider this trial
Good fit: Adults over 18 who can give informed consent, speak German or Swiss German, had an elective cesarean under neuraxial anesthesia within the past 48–72 hours, and delivered a healthy infant of at least 35+1 weeks' gestation.
Not a fit: People with known fetal abnormalities or neonatal death, neonatal ICU admission, severe postpartum hemorrhage (>1000 mL), preeclampsia, current severe psychiatric disease, substance abuse, or chronic pain disorders are excluded and unlikely to benefit from this tool.
Why it matters
Potential benefit: If successful, the tool could help clinicians and researchers better recognize and document pain during cesarean delivery, improving pain management and study quality.
How similar studies have performed: The protocol uses established methods (literature review, Delphi consensus, and patient interviews) commonly used to develop clinical measurement tools, but a dedicated patient-centered intraoperative cesarean pain instrument is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age \> 18 years * Proficient in German or Swiss German * Elective cesarean delivery under neuraxial anesthesia in last 48-72 hours * Delivery of an healthy infant of at least 35+1 weeks of gestation Exclusion Criteria: * Known fetal abnormalities or neonatal death * Admission of the neonate to the ICU * Severe postpartum hemorrhage of \>1000ml blood loss * Preeclampsia * Current psychiatric disease, e.g. schizophrenia, personality disorders * Substance abuse * Chronic pain disease
Where this trial is running
Basel, Canton of Basel-City
- University Hospital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lena Gschwandtner
- Email: lenaanna.gschwandtner@usb.ch
- Phone: +41 61 328 33 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.