ACTRN12619001166167已完成未知
The Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •(a)Nulliparous mothers in the 3rd trimester of pregnancy (i.e., 26-32 weeks gestation and no older children).
- •(b)Singleton pregnancy;
- •(c)Age >= 18 years.
- •(d)Able to read and write in English.
- •(e)Have regular access to a smartphone, email, and internet.
- •(f)Score > 7 on the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).
排除标准
- •(a)Participants who use medications or substance that directly effect sleep (including sleep medications, melatonin, steroid inhalers, antidepressant medications, cannabis, etc.)
- •(b)Unstable medical conditions that directly affect sleep;
- •(c)Participants who show the following symptoms of sleep disorders:
- •a.Sleep apnea: loud snoring OR observed gasping or pauses in breathing OR previously diagnosed with apnea hypopnea index >15 but not/inadequately treated
- •b.Previously diagnosed Periodic Limb Movement Disorder with arousal index > 15
- •c.Restless Legs Syndrome (RLS; based on structured interview) occurring greater than or equal to 3 times/week, with duration of at least one month and onset prior to pregnancy. Include even if RLS increased or emerged during pregnancy (as long as pre-pregnancy frequency was no more than once a week before pregnancy and duration criterion was met).
- •d.Circadian rhythm disorders (based on structured interview):
- •Irregular Sleep Wake Disorder
- •Non-24-Hour Sleep-Wake Syndrome
- •Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8 pm and habitual wake time is earlier than 4 am. Occasional deviation from this schedule is allowed.)
- •Delayed Sleep-Phase Syndrome (if habitual bed time is later than 3 am and habitual wake time is later than 11 am. Occasional deviation from this schedule is allowed.)
- •Fixed night shift work between midnight and 5 a.m., or rotating work schedules that require night shifts during the course of their pregnancy or during their participation.
- •Narcolepsy.
- •e.Other previously diagnosed sleep disorders – if severe (discuss with PI)
- •(d)Report severe current psychopathology, including posttraumatic stress disorder, panic disorder (if > 4 nocturnal panic attacks in the past month), substance abuse/dependence disorders; OR life-time bipolar or psychotic disorders; OR having high risk of harm to self or others. Those with current suicidal ideation/self-harm behaviours or those who pose a high risk of harm to others will be excluded and referred to appropriate services.
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