Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
时间窗: 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.
次要结局
- Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery.(48-72 hours postoperatively)