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

March 4, 2026 updated by: Emine Uzuntarla Güney, Karabuk University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sleep is a critical determinant of infants' neurodevelopment, emotional regulation, and physical health, and early sleep problems are associated with adverse outcomes for both children and families. Parental perceptions of infant sleep and parental self-efficacy play a central role in shaping sleep-related caregiving practices. Although various infant sleep interventions exist, many are heterogeneous in content and intensity, and some behaviorally oriented approaches raise ethical and developmental concerns due to potential negative effects on parent-infant attachment and stress regulation. Moreover, structured, attachment-sensitive, and sleep hygiene-based educational interventions initiated during pregnancy remain limited in the literature.

This randomized controlled trial will evaluate the effectiveness of a structured Infant Sleep Hygiene Education Program delivered prenatally to pregnant women, with continued postnatal follow-up, on infant sleep habits and parental self-efficacy related to infant sleep. The intervention is grounded in developmental and attachment-informed principles and emphasizes ethical, responsive caregiving strategies rather than extinction-based sleep training methods. Core components of the program include:

developmentally appropriate sleep expectations, infant temperament-sensitive approaches, establishment of consistent and predictable bedtime routines, environmental sleep hygiene (light, noise, temperature), responsive soothing strategies, and parental coping and stress regulation skills. Participants will be randomly allocated to an intervention group or a control group receiving routine antenatal care. The education program will be delivered in multiple structured sessions during pregnancy and reinforced with postnatal follow-up support. Outcomes will be assessed at baseline (prenatal) and at 1, 3, and 6 months postpartum.

Primary outcomes are parental self-efficacy regarding infant sleep and infant sleep habits (e.g., night waking frequency, sleep duration, sleep onset latency, and routine consistency). 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.

Process and program evaluation outcomes will assess parental knowledge about infant sleep hygiene before and after the education program, adherence to the intervention content, completion of sleep diaries, and parental satisfaction with the education sessions.

This study aims to contribute to the development of an ethical, developmentally appropriate, and preventive infant sleep education model that supports healthy sleep habits while strengthening parental competence and promoting sustainable sleep-supportive caregiving practices. Findings may inform maternal-child health services and early preventive interventions integrated into routine prenatal care.

In addition to primary and secondary clinical outcomes, a process evaluation framework will be used to assess the implementation quality and feasibility of the education program. This will include assessment of parental knowledge about infant sleep before and after the education sessions, adherence to recommended sleep-supportive parenting practices, completion of infant sleep diaries, and participant satisfaction with each education session. Furthermore, the mediating role of parental self-efficacy in the relationship between the intervention and infant sleep outcomes will be examined to better understand the mechanisms of change.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Infant Sleep Hygiene Education Program
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
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.
Other Names:
  • Prenatal Parent Sleep Education Program
No Intervention: Control: Routine Antenatal Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental self-efficacy regarding infant sleep
Time Frame: Baseline (prenatal), 1 month, 3 months, and 6 months postpartum
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)
Time Frame: 1 months, 3 months, and 6 months postpartum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karabuk University

Collaborators

Zonguldak Bulent Ecevit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-77192459-050.99-466663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Self Efficacy

Clinical Trials on Infant Sleep Hygiene Education Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe