Sleep Disruption in New Parents: An Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Maternal Sleep Quantity (Objective)
研究概览
简要总结
The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women expecting first singleton birth
- •able to speak, read, and write in English
- •willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum
- •willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization
排除标准
- •history of affective illness prior to pregnancy
- •current use of medications that may alter sleep
- •history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy
- •plan to employ live-in help with child care
- •working the night-shift
- •multiple pregnancy with twins or more
研究组 & 干预措施
Dietary information & standard care
Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive no intervention beyond standard immunization care.
干预措施: Dietary information (Behavioral)
Sleep hygiene & standard care
Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive standard immunization care.
干预措施: Sleep hygiene (Behavioral)
Sleep hygiene & acetaminophen
Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.
干预措施: Sleep hygiene (Behavioral)
Sleep hygiene & acetaminophen
Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Maternal Sleep Quantity (Objective)
时间窗: 1-month postpartum (approximately)
Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
Maternal Sleep Quality (Objective)
时间窗: 1 month postpartum (approximately)
Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.
Change in Infant Sleep Quantity (Objective)
时间窗: 24 hours before and 24 hours after immunizations at approximately 2 months of age
Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.
次要结局
- Maternal Sleep Disturbance (Subjective)(1 month postpartum (approximately))
- Maternal Well-being(1 month postpartum (approximately))