Efficacy of Parent-child Sleep Intervention to Improve Sleep Quality, Psychological Health, and Infant Health in Parents of Neonates.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Change from Baseline in insomnia severity on the Chinese Version of the Insomnia Severity Index (ISI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum
研究概览
简要总结
Background: Parents of healthy neonates commonly face sleep disruptions and disturbances after delivery. Notably, increasing challenges are evident among parents of ill infants who required clinical care after birth . These challenges can adversely affect psychological adaptation and parental efficacy which consequently impacting the infant's development. It is crucial to develop an effective parent-child sleep intervention for improving parent-infant sleep and mental well-being and uneventful family health outcomes.
Aim: To develop and evaluate the effects of parent-child sleep intervention on improving sleep quality, psychological health, and infant health in parents of infants at intermediate care nursery.
Methods: A randomized controlled trial will be conducted at the intermediate care nursery of a level III medical center at Taipei city. A total of 102 pairs of parents and infants will be recruited and randomly assigned to the experimental group or the control group. The intervention program consists of (1) parent-child sleep education, (2) heart rate variability biofeedback training, and (3) counseling and support. Data collection will be multiple time points, including baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum.
Anticipated results: Developing and evaluating a parent-child sleep intervention for postpartum parents and their infants. The findings will be an empirical evidence for pediatric care and family health promotion.
详细描述
The following measures will be used, including Insomnia Severity Index, Pittsburgh Sleep Quality Index, Brief Infant Sleep Questionnaire-Revised short form, Parental Efficacy Scale, State-Trait Anxiety Inventory, Infant Health Outcome Questionnaire. Objective data included actigraphy, and heart rate variability. Data will be analyzed using descriptive statistics and One-Way repeated measure ANOVA to examine the effectiveness of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Postpartum women aged 18 years or older.
- •Postpartum women with a singleton pregnancy, and the gestational age of their infant is at least 32 weeks.
- •Postpartum women with a severe insomnia severity index score of ≥8 points.
- •Postpartum women and their husbands or partners capable of reading, understanding, and communicating in Mandarin.
- •Postpartum women and their husbands or partners with internet access and the ability to operate resources using a smartphone, tablet, or computer.
- •Both postpartum women and their husbands or partners are willing to participate in the research process.
排除标准
- •Postpartum women diagnosed with Insomnia Disorder, Anxiety Disorders, or Depression.
- •Postpartum women suffering from arrhythmia or cardiovascular diseases.
- •Postpartum women working in shifts.
- •Infants with congenital abnormalities, neurological impairments (such as hydrocephalus, periventricular leukomalacia), requiring the use of tubes or respirators after discharge, or using medications that might affect sleep (such as caffeine, sedatives, muscle relaxant, anti-epileptic drugs, or pain medications).
结局指标
主要结局
Change from Baseline in insomnia severity on the Chinese Version of the Insomnia Severity Index (ISI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum
时间窗: Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum
The ISI is a validated, self-reported questionnaire assessing insomnia severity over the past month period. Possible scores range from 0 (absence of insomnia) to 28 (severe insomnia).
次要结局
- Change from Baseline in parenting efficacy and satisfaction on the Chinese Version of the Parenting Sense of Competence Scale (PSOC-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Infant health outcome(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Change from Baseline in sleep quality on the Chinese Version of the Pittsburgh sleep quality index (PSQI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Satisfaction questionnaire(immediately after intervention)
- Change from Baseline in heart rate variability (HRV) at 1 month postpartum, 3 months postpartum, and 6 months postpartum(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Change from Baseline in infant sleep quality on the Chinese Version of the Brief Infant Sleep Questionnaire-Revised Revised Short Form (BISQ-R-C SF) at 1 month postpartum, 3 months postpartum, and 6 months postpartum(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Change from Baseline in anxiety symptoms on the Chinese Version of State-Trait Anxiety Inventory (STAI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
- Activity and sleep monitor(Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum)
研究者
VGHuser_Chien-Hui Chan
Principal investigator
Taipei Veterans General Hospital, Taiwan