The Development and Evaluation of Sleep Intervention for Perinatal Family
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.
Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.
Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.
Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.
详细描述
The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First-time mothers and their partners aged 20 and older;
- •Currently 30 weeks gestation or more, singleton;
- •insomnia severity index score greater than 10;
- •living with a husband or partner;
- •Both women and their partners are willing to participate in and adhere to the research protocol;
- •be able to read and speak the Mandarin language
排除标准
- •sleep disorders, depression or anxiety disorders;
- •medical diseases with abnormal heart rate variability, or arrhythmia;
- •taking medicines that may affect the autonomic nervous system or
- •night shift workers;
- •obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
- •infants with fetal deformity, or neonatal complications;
- •no access to Internet resources
结局指标
主要结局
Insomnia Severity Index
时间窗: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum
The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms.
次要结局
- Sleep efficacy using actigraphy(baseline, postpartum 1 month, 3 months, and 6 months.)
- Infants sleep Questionnaire(postpartum 1 month, 3 months, 6 months, and 12-months)
- Heart rate variability (HRV) measures(at baseline, postpartum 1 month, 3 months, and 6 months)
- Sleep duration using actigraphy(baseline, postpartum 1 month, 3 months, and 6 months.)
- Wake after sleep onset using actigraphy(baseline, postpartum 1 month, 3 months, and 6 months.)
- Infant height(postpartum 3 months, 6 months, and 12-months)
- Satisfaction of sleep intervention(immediately after interventions)
- Sleep sleep onset latency using actigraphy(baseline, postpartum 1 month, 3 months, and 6 months.)
- Sleep quality(baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months)
- Depressive symptoms(baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months)
- Anxiety symptoms(baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months)
- Infant feeding(postpartum 1 month, 3 months, and 6 months, and 12 months)
- Infant weight(postpartum 3 months, 6 months, and 12-months)
- Infant development(postpartum 3 months, 6 months, and 12-months)