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临床试验/NCT04693130
NCT04693130已完成不适用

Effects of Mindfulness-based Prenatal Education on Biopsychological Health for Prenatal Mental Disorders Women

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2020年12月24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
102
试验地点
1
主要终点
stress

研究概览

简要总结

The purpose of this study is to explore the differences between stress, anxiety, depression, mindfulness, mother and infants bonding, salivary amylase activity, and postnatal maternal outcomes for prenatal mental disorders in women with mindfulness prenatal education program

详细描述

The aim of this study was to test the efficacy of a Mindfulness prenatal education program in reducing pregnant women's perceived stress, anxiety, depression, mindfulness, mother and infant bonding, and salivary alpha-amylase compared to a control group. The investigators hypothesize that using the mindfulness prenatal education program by the study group will lead to improved related mood symptoms compared with the control group.

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 30%, total 102 samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Subjects were at the age over 20
  • Could speak and read Chinese fluently
  • Willing and be ale to attend the education program

排除标准

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

研究组 & 干预措施

Mindfulness-based prenatal 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: Mindfulness-based prenatal education (Behavioral)

Hospital-based antenatal education

Placebo Comparator

Hospital-based antenatal education program.

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

结局指标

主要结局

stress

时间窗: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

Perceived stress scale, that was 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress

次要结局

  • depression(baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum)

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

研究点 (1)

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