Elective Cesarean DeliveryNCT07409012
Development of a Patient-Centered Assessment Tool for Pain During Cesarean Delivery
An observational study of Elective Cesarean Delivery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to develop a standardized tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. 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
- Elective Cesarean Delivery
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2026to Sep 2026
- Phase
- Observational
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: In-Hospital patients which stay at the maternity ward at the University Hospital Basel after cesarean delivery.
Who may be able to join
- Signed informed consent
- Age > 18 years
- Proficient in German or Swiss German
- Category 2-4 Cesarean delivery under neuraxial anesthesia within last 48-72 hours
- Delivery of an healthy infant of at least 35+1 weeks of gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City
Lena Anna Gschwandtner, Doctoral candidate, +41 61 32 83351, lenaanna.gschwandtner@usb.ch
About this study
Official title: Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
This study aims to develop a standardized tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. Experts from multiple disciplines will participate in a structured consensus process (Delphi process) to identify and refine key assessment items. Patient interviews will be conducted to ensure that the tool reflects patient priorities and experiences.
- Conditions
- Elective Cesarean Delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
As this is a study focusing on methodological development, the primary outcome is the establishment of a consensus-based, patient-centered assessment tool. This tool is derived from a literature review and finalized through a Delphi process (expert consensus) and patient-centered via cognitive interviews. As the outcome of this study is the finalized set of items, the tool will not be clinically applied to measure the incidence of pain during cesarean delivery within this study. It serves as a foundation for future psychometric validation and clinical application.
Measured: 48-72 hours postoperatively
Secondary outcomes (1)
Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery.
The secondary measure will be assessed in the qualitative interviews with patients after cesarean delivery, during which the items for the assessment tool will be discussed as well. Patients will be asked to share their informational priorities and what they want to know before undergoing a cesarean delivery. To measure this outcome, inductive coding and thematic analysis will be used to identify themes that describe these priorities.
Measured: 48-72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start11 May 2026
- Primary completion30 Jun 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cesarean DeliveryStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409012
- Sponsor's protocol ID
- PDCD
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No