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临床试验/NCT04888013
NCT04888013已完成不适用

The Impact of Birth Environment and Childbirth-stress, Birth Control & Outcome

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
2
主要终点
Visual Analogue Stress Scale

研究概览

简要总结

This research improves the correlation between birth control and birth outcomes by understanding the childbirth environment and birth stress. A Quasi Experiment research . The sample size was calculated using a two-tailed test, the significance level α was 0.05, the power was 80%, three groups of repeated measurements were taken three times, the effect size (effect size) was set to medium.25, and the required number of samples was 108 people, resulting in a 20% wastage rate, a total of 129 people are needed, so each of the three groups is expected to accept 43 people.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Be at least 20 years old,
  • Those who agree to participate in this research and can read and write Chinese,
  • vaginal delivery
  • Those who have no high-risk complications or chronic diseases during pregnancy and childbirth.

排除标准

  • Those who have been diagnosed with mental illness by a doctor, including those with depression and mood disorders
  • Exclude stillbirths and newborns with congenital abnormalities

结局指标

主要结局

Visual Analogue Stress Scale

时间窗: From latent phase to postpartum 2 hours

The visual analogue scale for stress is a horizontal line of 0-10 cm. It is divided into the maximum level of stress. 0 means no stress at all, and 10 means extreme stress. The individual will point out the most suitable value for the feeling at this moment. Centimeters represent one point, and fractions gradually represent a decrease in the score

salivary amylase

时间窗: From latent phase to postpartum 2 hours

he measurement standard values are as follows: 30 kIU/L is no pressure; 31\~45 kIU/L is a small amount of pressure; 46\~60 kIU/L is a moderate pressure; more than 61 kIU/L is a severe pressure.

Heart rate variability

时间窗: From latent phase to postpartum 2 hours

The heart rate variability measurement uses TS-0411 sample, wrist-type physiological monitor (approved by the Department of Health No. 5200277), with multiple built-in biological sensors, which have been calibrated before leaving the factory to achieve high accuracy.

次要结局

  • Perception of Childbirth Environment Scale(through study completion, an average of Postpartum 24 hours)

研究者

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

Li-li Chen

RN PhD student

National Taipei University of Nursing and Health Sciences

研究点 (2)

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