Sleep HygieneNCT07458035
The Impact of a Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
A study testing Infant Sleep Hygiene Education Program in people with Sleep Hygiene and Infant Sleeping Habits, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Hygiene, Infant Sleeping Habits, Parent Education
- What is being tested?
- Infant Sleep Hygiene Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Karabuk University
Karabük, 78000
Karabuk University, +90 444 0 478, sbf@karabuk.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Sleep Hygiene, Infant Sleeping Habits, Parent Education, Self Efficacy
- Being tested
- Infant Sleep Hygiene Education Program
- Keywords
- infant sleep, sleep hygiene, parent education, educational program, comfort theory
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Sleep Hygiene Education ProgramBehavioural
Also called Prenatal Parent Sleep 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 months, 3 months, and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Responsible party
- Principal investigator, Emine Uzuntarla Güney, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458035
- Sponsor's protocol ID
- E-77192459-050.99-466663
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
- ClinicalTrials.gov ID
- NCT07458035
- Acronym / sponsor ID
- E-77192459-050.99-466663
- Conditions
- Sleep Hygiene, Infant Sleeping Habits, Parent Education, Self Efficacy
- Keywords
- infant sleep, sleep hygiene, parent education, educational program, comfort theory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Infant Sleep Hygiene Education Program | Experimental | Behavioral: Infant Sleep Hygiene Education ProgramParticipants 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Sleep Hygiene Education ProgramAlso: Prenatal Parent Sleep Education ProgramParticipants 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. | Behavioural | Intervention: Infant Sleep Hygiene Education Program |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Sleep Hygiene Education Program in people with Sleep Hygiene and Infant Sleeping Habits, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Uzuntarla Güney, PhD student (+90(370)418-9415, emineguney@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental self-efficacy regarding infant sleep (time frame: Baseline (prenatal), 1 month, 3 months, and 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.