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临床试验/NCT03185910
NCT03185910Unknown不适用

The Efficacy of a Mindfulness-Based Childbirth and Parenting Education on Pregnant Women's Childbirth Self-efficacy, Psychological Health and Maternal Outcomes: A Randomized Controlled Trial

National Taipei University of Nursing and Health Sciences0 个研究点目标入组 104 人开始时间: 2016年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
104
主要终点
change of prenatal and postnatal stress

研究概览

简要总结

The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.

详细描述

Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes.

Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group).

The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
  • •Subjects were at the age over 20
  • •Could speak and read Chinese fluently
  • •Willing and be able to attend the education program
  • •Determined to have a vaginal birth

排除标准

  • •Taking medication for diagnosing mental illness
  • •With complicated or high-risk pregnancies

研究组 & 干预措施

MBCP education

Experimental

The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.

干预措施: MBCP education (Behavioral)

Hospital-based antenatal education

Placebo Comparator

Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.

干预措施: Hospital-based antenatal education (Behavioral)

结局指标

主要结局

change of prenatal and postnatal stress

时间窗: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale

次要结局

  • change of mindfulness(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)
  • postpartum medical records(After the childbirth within 24 hours will be collected)
  • change of the childbirth self-efficacy(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)
  • change of symptoms with depression and anxiety(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)

研究者

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

Wan-Lin Pan

Nursing department

National Taipei University of Nursing and Health Sciences

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