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临床试验/NCT01177046
NCT01177046已完成不适用

Development of a Multi-attribute Health Index to Measure the Quality of Labour Analgesia: Psychometric Development of a Quality of Neuraxial Labour Analgesia Scale

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
752
试验地点
1
主要终点
Psychometric instrument development study

研究概览

简要总结

The findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

详细描述

The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Use of neuraxial labour analgesia during the current pregnancy
  • Native English-speakers
  • Term pregnancies (>37-42weeks)
  • The ability to read and write in English
  • Provision of written informed consent.

排除标准

  • Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement
  • Women with evidence or history of maternal cognitive impairment
  • Women who experienced a neonatal death during the current pregnancy

结局指标

主要结局

Psychometric instrument development study

时间窗: 5-6 years

Exploration and description of language, nature, and variability of women's pain experiences during labour and delivery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pamela Angle

Anesthesiologist

Sunnybrook Health Sciences Centre

研究点 (1)

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