Elective Cesarean Delivery
Conditions
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.
Interventions
None listed
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The development of an assessment tool with a consensus-based item set for pain during caesarean delivery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery. | 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. |
Countries
Switzerland
Contacts
CONTACTLena Gschwandtner
Outcome results
None listed