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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
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.

Time frame
48-72 hours postoperatively

Other outcomes

Sponsors and contacts

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