Development of a Patient-Centered Assessment Tool for Pain During Cesarean Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Elective Cesarean Delivery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
Overview
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.
Primary outcome measures
- The development of an assessment tool with a consensus-based item set for pain during caesarean delivery. [Time frame: 48-72 hours postoperatively]
Secondary outcome measures (1)
- Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery. [Time frame: 48-72 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07409012 · PDCD