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临床试验/NCT07031622
NCT07031622已完成不适用

Determining the Effect of Yoga Exercises on Psychological Health and Childbirth Trauma in Pregnant Women

Sakarya University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
pre-test post-test

研究概览

简要总结

This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.

Study Design:

A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.

Population and Sample:

The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta.

A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.

详细描述

Title: The Effect of Yoga on Mental Health and Trauma in Pregnant Women

Study Description (Brief Summary):

This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.

Study Design:

A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

In this study, after the participants agreed to participate, they were assigned to the intervention and control groups using the simple randomization method. In the randomization process, participants were assigned odd and even numbers according to the order of application to the center. Those given odd numbers formed the intervention group. In contrast, those given even numbers formed the control group. This method was used to ensure equal distribution of the groups and to prevent selection bias. In the blinding process, the study was conducted with a single-blind design. Participants knew which group they were in, but the researchers who implemented the intervention and the statistical expert who analyzed the data were unaware of the groups' distribution, except for the person who performed the randomization. Thus, observer bias and assessment bias were minimized during the statistical analysis phase.

This method was preferred to prevent factors that may affect participation in the i

入排标准

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

入选标准

  • Over 18 years old
  • Over 16 weeks
  • Without a diagnosis of high-risk pregnancy
  • Not exercising before pregnancy
  • Planned pregnancy

排除标准

  • Hypertension
  • Gestational diabetes
  • Short cervical length
  • Low-lying placenta

结局指标

主要结局

pre-test post-test

时间窗: 1 year

This study was conducted using the "pre-post test matched group model" to investigate the effects of yoga exercises on the reduction or prevention of childbirth trauma.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GÜLESER ADA

Dr

Bartın Unıversity

研究点 (2)

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