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临床试验/NCT05933993
NCT05933993已完成不适用

Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.

Sygehus Lillebaelt2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Pain

研究概览

简要总结

Background and aim:

In Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover.

The Danish national anesthesiological research network, CEPRA (Collaboration for Evidence based Practice and Research in Anesthesia) is planning a national study on pain following elective cesarean sections. In order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how Danish women experience pain, recovery and function following an elective cesarean section.

Methods:

This is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.

The study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).

Women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.

Women will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. Participation is completely voluntary. If they to participate, participants will sign a consent form. The investigators will include and interview participants until data saturation occurs. It is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals.

Interviews will be held by telephone, recorded digitally and transscribed verbatim. Transscribed interviews will be coded for categories and themes using the NVivo software. Data will be analysed using manifest content analysis.

Baseline characteristics will be handled with descriptive statistics.

The primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing an elective cesarean section under spinal anesthesia
  • speaking/writing Danish

排除标准

  • cesarean section performed under general anesthesia

结局指标

主要结局

Pain

时间窗: 4 to 7 days after the elective cesarean section

The primary outcome of the study is a thematic analysis of Danish womens experience of pain following an elective cesarean section. As the study is qualitative, no scale will be used to measure pain, but instead the experience of pain as described by the participants.

次要结局

  • Recovery(4 to 7 days after the elective cesarean section)
  • Physical function(4 to 7 days after the elective cesarean section)

研究者

发起方
Sygehus Lillebaelt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helene Korvenius Nedergaard

Primary investigator

Sygehus Lillebaelt

研究点 (2)

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