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NOT YET RECRUITING
NCT07458035
NA

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

Sponsor: Karabuk University

View on ClinicalTrials.gov

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.

Official title: The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-06

Completion Date

2027-03

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

Locations (1)

Karabuk University

Karabük, Turkey (Türkiye)