Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial
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
- 是
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
Yuh-Kae Shyu
Assistant Professor
Ministry of Science and Technology, Taiwan
