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临床试验/NCT03334097
NCT03334097已完成不适用

Educational Intervention in the Fear-Avoidance Delivery: a Prospective Study.

University of Malaga1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Responsiveness of WDEQ-A-Sp after an educational intervention

研究概览

简要总结

The aim of this research is to study the responsiveness of the Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A) in pregnant women after an educational intervention.

详细描述

The Wijma Delivery Expectancy/Experience Questionnaire is a self-report instrument designed to measure the fear of childbirth in terms of the woman's cognitive appraisal of childbirth, which is now the most commonly used measure of fear of childbirth. The version A, measures the fear before a delivery (WDEQ-A). It consists of 33 items on a 6-point Likert scale (0 = do not agree; 5 = totally agree). The total score ranges from 0 to 165; the higher the score, the greater the fear the pregnant women experience. A higher score (over 85) indicates a more intense fear of childbirth, and a score of over 100 is considered as a phobia; thus, the scale can measure individual degrees of fear among women before and after their deliveries In Spain, there is no specific instrument to test the effectiveness of different practices that are commonly used to reduce the fear of childbirth as the maternal education. Hence, after cross-cultural adaptation into Spanish of the questionnaire (WDEQ-A-Sp), the responsiveness after and educational intervention will be analysed.

Descriptive analyses will be applied to calculate means and standard deviations of the demographic variables. Distribution and normality will be determined by the one-sample Kolmogorov-Smirnov tests (significance >0.05). Responsiveness will calculated following COSMIN requirements.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

There will be no masking as the purpose of the study is to analyse responsiveness of a questionnaire after educational intervention

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

  • •Spanish women living in Málaga, > 18 years old, 26-30 weeks pregnant, to fill all the items of the questionnaires, to perform sessions the Maternal Education Protocol in Malaga

排除标准

  • •No performin inclusion criteria. No voluntary participation.

研究组 & 干预措施

Experimental arm

Experimental

There will only one experimental arm in order to study test-retest validity after having validate the questionnaire. The beginning of the maternal education takes place between 26 and 30 weeks of gestation and ends between 32 and 36 weeks of gestation. Hence, to study responsiveness, questionnaires will be filed at the beginning of the maternal education and after the two educational sessions related to childbirth.

干预措施: Prenatal education (Other)

结局指标

主要结局

Responsiveness of WDEQ-A-Sp after an educational intervention

时间窗: inmediate effect

Responsiveness of Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A-Sp) after an educational intervention in pregnant women

次要结局

  • Previous experience of pregnancy(baseline, inmediate effect and 2,4 and 12 weeks.)
  • Weeks of gestation(baseline)
  • Obstetric history(baseline)
  • evolution of pregnancy(baseline, inmediate effect and 2,4 and 12 weeks.)
  • Age(baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months)
  • civil status(baseline)
  • Weight(baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months)
  • Height(baseline)
  • Body Mass Index(aseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months)
  • Educational level(baseline)

研究者

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

Dr. Antonio I Cuesta-Vargas

Principal Researcher CTS631

University of Malaga

研究点 (1)

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