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

April 23, 2026 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland
        • Recruiting
        • University Hospital Basel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
Time Frame: 48-72 hours postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery.
Time Frame: 48-72 hours postoperatively
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.
48-72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PDCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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