Sleep Health Care in Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Sleep by actigraphy
研究概览
简要总结
Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.
详细描述
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •During the first trimester of pregnancy
- •Singleton pregnancies
排除标准
- •Women have pregnancy-related complications
- •Women have diagnosed a psychiatric or sleep disorder
研究组 & 干预措施
Experimental
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
干预措施: Sleep intervention (Behavioral)
Control
Women in the control group will receive standard obstetric care.
结局指标
主要结局
Sleep by actigraphy
时间窗: Through study completion, an average of 16 weeks
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist
次要结局
未报告次要终点