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Clinical Trials in Turkey / NCT07458035
Starting soon Not applicable

The Impact of a Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy

NCT07458035 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-06
Last updated
2026-03-09

Condition(s) studied

Sleep HygieneInfant Sleeping HabitsParent EducationSelf Efficacy

Investigational drug(s) / intervention(s)

Infant Sleep Hygiene Education Program

Infant Sleep Hygiene Education Program: Participants will receive a structured, parent-centred Infant Sleep Hygiene Education Program delivered in multiple sessions during pregnancy, with postnatal follow-up support. The program is based on developmental and attachment-informed principles and focuses on responsive caregiving, establishing consistent bedtime routines, and evidence-based sleep hygiene practices, including environmental adjustments, soothing strategies, and parental coping skills.

Study summary

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

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Being a primiparous pregnant woman (first pregnancy) 2. Being between 24 and 32 weeks of pregnancy 3. Having a risk-free pregnancy 4. Not having a mental disorder 5. Speaking and understanding Turkish as a native language 6. Being literate 7. Not having received training on infant sleep 8. Agreeing to participate in the study Exclusion Criteria: 1. The baby being born outside of the 38th to 42nd week of pregnancy 2. The baby having a birth weight of less than 2,500 grams or more than 4,000 grams 3. The baby being admitted to the neonatal intensive care unit after birth 4. The baby having a condition that affects sleep, such as colic or hernia 5. The baby having a chronic illness 6. The parent wanting to leave work

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Karabuk University Karabük Turkey (Türkiye)

More Karabuk University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07458035 on ClinicalTrials.gov ↗ ← All trials in Turkey