About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known fetal abnormalities or neonatal death
Admission of the neonate to the ICU
Severe postpartum hemorrhage of >1000ml blood loss
Preeclampsia
Trial population
In-Hospital patients which stay at the maternity ward at the University Hospital Basel after cesarean delivery.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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