The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Parental self-efficacy regarding infant sleep
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a structured, Infant Sleep Hygiene Education Program initiated during pregnancy on infant sleep habits and parental self-efficacy related to infant sleep in the postpartum period. The program is grounded in developmental science and attachment-sensitive principles and focuses on promoting healthy sleep habits through responsive caregiving, consistent bedtime routines, and evidence-based sleep hygiene practices.
Pregnant women will be randomly assigned to either an intervention group receiving a multi-session prenatal education program with postnatal follow-up support, or a control group receiving routine antenatal care. Primary outcomes include parental self-efficacy regarding infant sleep and infant sleep habits (e.g., night awakenings, sleep duration, sleep onset latency, and routine consistency), assessed at 1, 3, and 6 months postpartum.
Secondary outcomes include adherence to recommended sleep-supportive parenting practices and infant sleep diary indicators. In addition, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined. Program evaluation outcomes will assess parental knowledge before and after the education, participation and adherence to the sessions, and parental satisfaction with the education program.
This study aims to provide evidence for an ethical, developmentally appropriate, and preventive infant sleep education model integrated into routine prenatal care.
详细描述
Sleep is a critical determinant of infants' neurodevelopment, emotional regulation, and physical health, and early sleep problems are associated with adverse outcomes for both children and families. Parental perceptions of infant sleep and parental self-efficacy play a central role in shaping sleep-related caregiving practices. Although various infant sleep interventions exist, many are heterogeneous in content and intensity, and some behaviorally oriented approaches raise ethical and developmental concerns due to potential negative effects on parent-infant attachment and stress regulation. Moreover, structured, attachment-sensitive, and sleep hygiene-based educational interventions initiated during pregnancy remain limited in the literature.
This randomized controlled trial will evaluate the effectiveness of a structured Infant Sleep Hygiene Education Program delivered prenatally to pregnant women, with continued postnatal follow-up, on infant sleep habits and parental self-efficacy related to infant sleep. The intervention is grounded in developmental and attachment-informed principles and emphasizes ethical, responsive caregiving strategies rather than extinction-based sleep training methods. Core components of the program include:
developmentally appropriate sleep expectations, infant temperament-sensitive approaches, establishment of consistent and predictable bedtime routines, environmental sleep hygiene (light, noise, temperature), responsive soothing strategies, and parental coping and stress regulation skills. Participants will be randomly allocated to an intervention group or a control group receiving routine antenatal care. The education program will be delivered in multiple structured sessions during pregnancy and reinforced with postnatal follow-up support. Outcomes will be assessed at baseline (prenatal) and at 1, 3, and 6 months postpartum.
Primary outcomes are parental self-efficacy regarding infant sleep and infant sleep habits (e.g., night waking frequency, sleep duration, sleep onset latency, and routine consistency). Secondary outcomes include adherence to recommended sleep-supportive parenting practices and infant sleep diary indicators. In addition, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined.
Process and program evaluation outcomes will assess parental knowledge about infant sleep hygiene before and after the education program, adherence to the intervention content, completion of sleep diaries, and parental satisfaction with the education sessions.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the behavioral and educational intervention, participants and intervention providers cannot be blinded to group allocation. Therefore, the study is conducted as an open-label trial.
To reduce assessment and analysis bias, participants will be assigned unique study codes, and all datasets will be anonymized using pseudonyms. The researcher responsible for data entry and statistical analysis will be blinded to group allocation. Group labels will be concealed and revealed only after completion of the primary analyses.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being a primiparous pregnant woman (first pregnancy)
- •Being between 24 and 32 weeks of pregnancy
- •Having a risk-free pregnancy
- •Not having a mental disorder
- •Speaking and understanding Turkish as a native language
- •Being literate
- •Not having received training on infant sleep
- •Agreeing to participate in the study
排除标准
- •The baby being born outside of the 38th to 42nd week of pregnancy
- •The baby having a birth weight of less than 2,500 grams or more than 4,000 grams
- •The baby being admitted to the neonatal intensive care unit after birth
- •The baby having a condition that affects sleep, such as colic or hernia
- •The baby having a chronic illness
- •The parent wanting to leave work
研究组 & 干预措施
Intervention: Infant Sleep Hygiene Education Program
Participants in this arm will receive a structured, parent-centred Infant Sleep Hygiene Education Program delivered in multiple sessions during pregnancy, followed by standardized postnatal follow-up support. The program is grounded in developmental and attachment-informed principles and focuses on responsive caregiving, establishment of consistent bedtime routines, and evidence-based sleep hygiene practices.
干预措施: Infant Sleep Hygiene Education Program (Behavioral)
Control: Routine Antenatal Care
Participants in this arm will receive routine antenatal care according to standard clinical practice, without any additional structured education related to infant sleep or postnatal follow-up support.
结局指标
主要结局
Parental self-efficacy regarding infant sleep
时间窗: Baseline (prenatal), 1 month, 3 months, and 6 months postpartum
Parental confidence in managing and supporting their infant's sleep will be assessed using the validated Turkish version of the Uppsala Parental Self-Efficacy about Infant Sleep Instrument (UPPSEISI). The UPPSEISI is an 11-item, two-factor, 5-point Likert-type scale that assesses parental self-efficacy related to infant sleep. It consists of two subscales: Child Sleep Needs (6 items), which measures parents' self-efficacy in managing difficulties related to ensuring that the child sleeps sufficiently at appropriate times, and Difficult Parenting (5 items), which assesses parents' self-efficacy in coping with practical challenges of putting the child to sleep and difficulties arising from the parent's own disrupted sleep. Total scores range from 11 to 55, with higher scores indicating greater parental self-efficacy in managing infant sleep-related challenges.
Brief Infant Sleep Questionnaire-Revised (BISQ-R)
时间窗: 1 months, 3 months, and 6 months postpartum
The scale is a parent-reported questionnaire used to assess infants' and toddlers' sleep patterns and sleep-related behaviors. The Brief Infant Sleep Questionnaire-Revised (BISQ-R) assesses sleep over the previous two weeks in children aged 0-36 months and includes items on demographic characteristics and infant sleep. The questionnaire evaluates three main domains: Infant Sleep, Parent Perception, and Parent Behavior. Scores are scaled from 0 to 100, with higher scores indicating better sleep quality, more positive parental perceptions of infant sleep, and parental behaviors that support healthy and
次要结局
未报告次要终点
研究者
Emine Uzuntarla Güney
Research Assistant
Karabuk University