Tips for Infant and Parent Sleep (TIPS) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks.
研究概览
简要总结
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.
详细描述
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Hours 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton baby born at GA >37 weeks
- •baby 8 hours to 7 days old
- •Mother age 16-50 years
- •Normal, healthy infant as described in newborn examination
- •First time parents living in the Greater Toronto Area
- •Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home
排除标准
- •Maternal or infant complications requiring prolonged hospital stay
- •Previous stillbirth or neonatal death
- •Maternal chronic illness
- •Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
- •Known drug or alcohol use beyond occasional social use
- •Smoking two packs a day or more
- •Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
- •Mother's partner is working night shifts
- •Mother unable to read or understand English
- •No telephone in the home
- •Involvement in another research protocol involving sleep
研究组 & 干预措施
Usual care
TIPS Intervention
干预措施: TIPS Intervention (Behavioral)
结局指标
主要结局
Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks.
时间窗: 6 weeks postpartum
次要结局
- Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks(6 weeks postpartum)
- depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks(6 weeks postpartum)
- Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)(6 weeks postpartum)
- Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night(6 weeks postpartum)
- levels of relatively transient, situation-related (state) anxiety as measured by the State-Trait Anxiety Inventory, state-anxiety subscale (Spielberger, 1970)at baseline and 6 weeks(6 weeks postpartum)
- intervention use, perceived helpfulness of interventions, satisfaction with TIPS Pilot study involvement, and preferences for interventions and data collection methods will be assessed using a questionnaire at 6 weeks(6 weeks postpartum)
研究者
Robyn Stremler
Nursing Research Associate
The Hospital for Sick Children