Sleep Disruption in New Mothers: An Intervention Trial (MOMS)
Sleep Disruption in New Parents: An Intervention Trial
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
San Francisco、California、美国、94143-0606
- University of California
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器: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. |
This intervention consists of dietary information aimed at improving postpartum sleep.
The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods.
|
实验性的: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. |
This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation. It is administered to women during their last month of pregnancy. |
实验性的: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. |
This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation. It is administered to women during their last month of pregnancy.
51-90mg depending on infant weight (12.5mg per kg infant weight).
Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maternal Sleep Quantity (Objective)
大体时间:1-month postpartum (approximately)
|
Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
|
1-month postpartum (approximately)
|
Maternal Sleep Quality (Objective)
大体时间: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.
|
1 month postpartum (approximately)
|
Change in Infant Sleep Quantity (Objective)
大体时间: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.
|
24 hours before and 24 hours after immunizations at approximately 2 months of age
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maternal Sleep Disturbance (Subjective)
大体时间:1 month postpartum (approximately)
|
Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS).
The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week.
GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.
|
1 month postpartum (approximately)
|
Maternal Well-being
大体时间:1 month postpartum (approximately)
|
Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D).
The CES-D measures depressive symptoms in the past week.
CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.
|
1 month postpartum (approximately)
|
合作者和调查者
调查人员
- 首席研究员:Kathryn A. Lee, RN, PhD、University of California, San Francisco
出版物和有用的链接
一般刊物
- Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. Res Nurs Health. 2011 Feb;34(1):7-19. doi: 10.1002/nur.20413. Epub 2010 Nov 17.
- Goyal D, Gay C, Lee KA. How much does low socioeconomic status increase the risk of prenatal and postpartum depressive symptoms in first-time mothers? Womens Health Issues. 2010 Mar-Apr;20(2):96-104. doi: 10.1016/j.whi.2009.11.003. Epub 2010 Feb 4.
- Kennedy HP, Gardiner A, Gay C, Lee KA. Negotiating sleep: a qualitative study of new mothers. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):114-22. doi: 10.1097/01.JPN.0000270628.51122.1d.
- Franck L, Gay CL, Lynch M, Lee KA. Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. Pediatrics. 2011 Dec;128(6):1100-8. doi: 10.1542/peds.2011-1712. Epub 2011 Nov 28.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.