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临床试验/NCT05474248
NCT05474248Unknown不适用

Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial

Ministry of Science and Technology, Taiwan2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年2月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
128
试验地点
2
主要终点
Postpartum anxiety

研究概览

简要总结

This is a two-group pretest-posttest, triple-blinded and randomized controlled trial examining the effects of a biofeedback-assisted diaphragmatic breathing training on postpartum anxiety. This study will include full-term postpartum women, aged from 20 to 49, who experienced anxious symptoms with State Anxiety Inventory (A-State) scored 40 or more at the first postpartum day. Participants will be randomly assigned to either an experimental group (n = 64) or a control group (n = 64). The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily. Participants in the control condition receive postpartum usual care. The outcome measures include anxiety measured by State-Trait Anxiety Inventory (STAI) and the physiological parameters expressed by blood pressure (BP) and heart rate (HR). Measurements will be taken at the first postpartum day and one month postpartum. We except this breathing training design is able to improve women's postpartum anxiety, and in turn improve their physio-psychological health, breastfeeding and baby care skills.

详细描述

Ditto

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • full-term postpartum women
  • aged from 20 to 49
  • STAI-S scored 40 or more at the first postpartum day

排除标准

  • newborn with severe illness or stillbirth
  • maternal suicide or self-harm
  • drug use: sedatives, hypnotics or antipsychotic drugs

结局指标

主要结局

Postpartum anxiety

时间窗: Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum

Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms

次要结局

  • Blood pressure(Post-test: Change from baseline heart rate at 4 weeks postpartum)
  • Heart rate(Post-test: Change from baseline heart rate at 4 weeks postpartum)

研究者

发起方
Ministry of Science and Technology, Taiwan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yuh-Kae Shyu

Assistant Professor

Ministry of Science and Technology, Taiwan

研究点 (2)

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