Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:43 AM
Study NCT ID:
NCT07458035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070263', 'term': 'Sleep Hygiene'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-06', 'size': 199483, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-28T05:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nTo 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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nThe 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.\n\nThe control group will receive routine antenatal care without any additional structured sleep-related education.\n\nRandomization 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental self-efficacy regarding infant sleep', 'timeFrame': 'Baseline (prenatal), 1 month, 3 months, and 6 months postpartum', 'description': "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."}, {'measure': 'Brief Infant Sleep Questionnaire-Revised (BISQ-R)', 'timeFrame': '1 months, 3 months, and 6 months postpartum', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant sleep', 'sleep hygiene', 'parent education', 'educational program', 'comfort theory'], 'conditions': ['Sleep Hygiene', 'Infant Sleeping Habits', 'Parent Education', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': '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.\n\nPregnant 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.\n\nSecondary 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.\n\nThis study aims to provide evidence for an ethical, developmentally appropriate, and preventive infant sleep education model integrated into routine prenatal care.', 'detailedDescription': "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.\n\nThis 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:\n\ndevelopmentally 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.\n\nPrimary 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.\n\nProcess 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.\n\nThis 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Pregnant women of any self-identified gender who are biologically female are eligible to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being a primiparous pregnant woman (first pregnancy)\n2. Being between 24 and 32 weeks of pregnancy\n3. Having a risk-free pregnancy\n4. Not having a mental disorder\n5. Speaking and understanding Turkish as a native language\n6. Being literate\n7. Not having received training on infant sleep\n8. Agreeing to participate in the study\n\nExclusion Criteria:\n\n1. The baby being born outside of the 38th to 42nd week of pregnancy\n2. The baby having a birth weight of less than 2,500 grams or more than 4,000 grams\n3. The baby being admitted to the neonatal intensive care unit after birth\n4. The baby having a condition that affects sleep, such as colic or hernia\n5. The baby having a chronic illness\n6. The parent wanting to leave work'}, 'identificationModule': {'nctId': 'NCT07458035', 'briefTitle': 'The Impact of a Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy', 'orgStudyIdInfo': {'id': 'E-77192459-050.99-466663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: Infant Sleep Hygiene Education Program', 'description': '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.', 'interventionNames': ['Behavioral: Infant Sleep Hygiene Education Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control: Routine Antenatal Care', 'description': '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': [{'name': 'Infant Sleep Hygiene Education Program', 'type': 'BEHAVIORAL', 'otherNames': ['Prenatal Parent Sleep Education Program'], 'description': '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.', 'armGroupLabels': ['Intervention: Infant Sleep Hygiene Education Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Karabuk University', 'role': 'CONTACT', 'email': 'sbf@karabuk.edu.tr', 'phone': '+90 444 0 478'}], 'facility': 'Karabuk University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'centralContacts': [{'name': 'Emine Uzuntarla Güney, PhD student', 'role': 'CONTACT', 'email': 'emineguney@karabuk.edu.tr', 'phone': '+90(370)418-9415'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Emine Uzuntarla Güney', 'investigatorAffiliation': 'Karabuk University'}}}}