Development of a Patient-Centered Assessment Tool for Pain During Cesarean Delivery

NCT07409012 | Recruiting

• 1 other identifier: PDCD
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  48-72 hours postoperatively

Secondary Outcomes (1)

• Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery.

  48-72 hours postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-Hospital patients which stay at the maternity ward at the University Hospital Basel after cesarean delivery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

RECRUITING

Central Study Contacts

Lena Gschwandtner

CONTACT

+41 61 328 33 51; lenaanna.gschwandtner@usb.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)