NCT07458035

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Mar 2027

First Submitted

Initial submission to the registry

February 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 28, 2026

Last Update Submit

March 4, 2026

Conditions

Sleep HygieneInfant Sleeping HabitsParent EducationSelf Efficacy

Keywords

infant sleepsleep hygieneparent educationeducational programcomfort theory

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline (prenatal), 1 month, 3 months, and 6 months postpartum

  • 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

    1 months, 3 months, and 6 months postpartum

Study Arms (2)

Intervention: Infant Sleep Hygiene Education Program

EXPERIMENTAL

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.

Behavioral: Infant Sleep Hygiene Education Program

Control: Routine Antenatal Care

NO INTERVENTION

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.

Interventions

Infant Sleep Hygiene Education ProgramBEHAVIORAL

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.

Also known as: Prenatal Parent Sleep Education Program
Intervention: Infant Sleep Hygiene Education Program

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women of any self-identified gender who are biologically female are eligible to participate.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Emine Uzuntarla Güney, PhD student

CONTACT

+90(370)418-9415emineguney@karabuk.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a parallel-group randomized controlled trial. Eligible pregnant women will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured Infant Sleep Hygiene Education Program delivered in multiple prenatal sessions, followed by standardized postnatal follow-up support. The program is parent-centred, developmentally informed, and attachment-sensitive, focusing on responsive caregiving, establishment of consistent bedtime routines, and evidence-based sleep hygiene practices. The control group will receive routine antenatal care without any additional structured sleep-related education. Randomization will be conducted at the individual level. Outcomes will be assessed at baseline during pregnancy and at 1, 3, and 6 months postpartum. The parallel design allows comparison of changes in parental self-efficacy related to infant sleep and infant sleep habits between the intervention and control groups over time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 28, 2026

First Posted

March 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data collected in this study will be analyzed and reported in aggregate form in the thesis and related publications. Individual participant-level data will not be shared with external researchers. All analyses will use anonymized data to protect participant privacy.

Locations

TU(1)