About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Infant Sleep Hygiene Education Program
Treatment groups
Sponsors and collaborators
Karabuk University
Lead sponsor
Zonguldak Bulent Ecevit University
Collaborator