NCT05065203已完成不适用
Evaluation of Inpatient Sleep and Activity Following Childbirth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Assessment of inpatient postpartum sleep using actigraphy
研究概览
简要总结
Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Little is known about sleep and activity levels in inpatients during nighttime and daytime following childbirth and how this may affect their mental and physical health and wellbeing. If abnormalities are identified, targeted interventions may be possible to optimize recovery following delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over 18 years old
- •live pregnancy
- •Single or multiple gestation
- •all gestational ages
排除标准
- •Weekend delivery
- •admitted to critical care
- •unable to speak or understand English
- •known sleeping disorder
- •opioid requirement prior to admission
- •long term steroids use
- •significant autoimmune or neurological disease
- •significant psychiatric or neurodevelopment disorder
结局指标
主要结局
Assessment of inpatient postpartum sleep using actigraphy
时间窗: During inpatient stay (up to 7 days)
Participants will wear an acitgraphy watch during their inpatient stay to measure sleep.
次要结局
- Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors(During inpatient stay and outpatient follow up (up to 7 days))
- Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)(Day 1-7, 6 and 12 weeks)
- Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors(6 and 12 weeks)
- Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs(Day 1-7, 6 and 12 weeks)
- Determine population norms of objective and subjective sleep measures in the postpartum population.(Day 1-7, 6 and 12 weeks)
- Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures(Day 1-7, 6 and 12 weeks)
研究者
PSultan
Associate Professor
Stanford University
研究点 (1)
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