The Impact of a Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorKarabuk University
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Infant Sleep Hygiene Education Program
BehavioralParticipants 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Intervention: Infant Sleep Hygiene Education ProgramExperimental treatment 1 intervention
Group B: Control: Routine Antenatal CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Parental self-efficacy regarding infant sleep
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.
Time frame
Baseline (prenatal), 1 month, 3 months, and 6 months postpartum2
Brief Infant Sleep Questionnaire-Revised (BISQ-R)
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
Time frame
1 months, 3 months, and 6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karabuk University
Lead sponsor
Zonguldak Bulent Ecevit University
Collaborator
Source ClinicalTrials.gov
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