Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT07299903
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000070263', 'term': 'Sleep Hygiene'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Baseline and 10 weeks after intervention', 'description': 'Change in sleep quality measured using the Menopause-Specific Sleep Quality Scale before and after the sleep hygiene education intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menopause', 'Sleep quality', 'Sleep hygiene', 'Depression', "Women's health", 'Randomized controlled trial'], 'conditions': ['Insomnia', 'Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in women during menopause. Women will be randomly assigned to either an education group or a control group. The education group will receive training based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the education. The results will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression in menopausal women.', 'detailedDescription': 'This study aims to evaluate the effects of sleep hygiene education on sleep quality and depression in menopausal women. The study will be conducted in two phases. In the first phase, a menopause-specific sleep quality scale will be developed to assess sleep habits, nighttime awakenings, sleep disruptors, and sleep hygiene behaviors in this population. In the second phase, participants will be randomly assigned to either a control group or an intervention group receiving sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep quality and depression levels will be measured before and after the intervention using validated psychological and physiological assessments. Daily sleep tracking logs will also be used to monitor adherence and intervention effectiveness. The findings will provide insight into whether sleep hygiene education can improve sleep quality and reduce depression among menopausal women, and will serve as a resource for developing nursing interventions and informing health policies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being in menopause\n* Being between 40 and 60 years of age\n* Having a low sleep quality score according to the Menopause-Specific Sleep Quality Scale.\n* Being willing to participate in the study.\n* Having no physical or mental disabilities that would hinder communication.\n* Having technology (smartphone, tablet, or computer) with internet access and the ability to participate in online training.\n\nExclusion Criteria:\n\n* Having a history of receiving psychological support.\n* Having been diagnosed with a chronic psychiatric illness (previously diagnosed depression, anxiety disorder, etc.).\n* Having a neurological or chronic systemic illness that may affect sleep quality.\n* Being treated for a sleep disorder (receiving medication or psychotherapy).\n* Receiving hormone replacement therapy (HT).\n* Having received sleep hygiene training/therapy within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT07299903', 'briefTitle': 'IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'The Effect of Information, Motivation, Behavioral Skills (IMB) Model-Based Sleep Hygiene Education on Sleep Quality and Depression Level in Menopausal Women: A Methodological and Experimental Study', 'orgStudyIdInfo': {'id': '20.11.2025-09/1541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Hygiene Education', 'description': 'Participants will receive sleep hygiene education based on the Information-Motivation-Behavioral Skills (IMB) Model. Sleep habits, routines, and behaviors to improve sleep quality will be taught. Sleep quality and depression will be measured before and after the intervention, and participants will maintain daily sleep logs.', 'interventionNames': ['Behavioral: Sleep Hygiene Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will receive standard care without additional sleep hygiene education. Sleep quality and depression will be measured at the same time points as the intervention group.'}], 'interventions': [{'name': 'Sleep Hygiene Education', 'type': 'BEHAVIORAL', 'description': 'Education based on the IMB Model targeting sleep habits, routines, and sleep hygiene behaviors to improve sleep quality.', 'armGroupLabels': ['Sleep Hygiene Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ankara Atatürk Sanatorium Training and Research Hospital', 'role': 'CONTACT', 'email': 'busrakaragol22@gmail.com', 'phone': '+90 544 574 56 95'}, {'name': 'Aytebn ARIÖZ DÜZGÜN', 'role': 'CONTACT'}], 'facility': 'Ankara Atatürk Sanatorium Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Busra Karagol', 'role': 'CONTACT', 'email': 'busrakaragol22@gmail.com', 'phone': '+90 544 574 56 95'}], 'overallOfficials': [{'name': 'Ayten ARIÖZ DÜZGÜN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Start Date9 months following article publication End Date36 months following article publication', 'ipdSharing': 'YES', 'description': 'IPD Sharing Plan: Yes. De-identified IPD (protocol, SAP, and raw outcome datasets for MSSQS and BDI) will be shared with researchers submitting a methodologically sound proposal. Data will be available starting 9 months post-publication and for 36 months. Access requires a signed Data Access Agreement (DAA). Contact the Principal Investigator at \\[busrakaragol22@gmail.com\\] for proposals.', 'accessCriteria': "Access is limited to qualified external researchers who submit a methodologically sound research proposal to the Principal Investigator at \\[busrakaragol22@gmail.com\\].\n\nResearchers will access de-identified IPD (including MSSQS/BDI data, Protocol, SAP, and Analytic Code).\n\nAccess is conditional upon two requirements:\n\nExecution of a Data Access Agreement (DAA).\n\nProvision of ethical approval (IRB/IEC) for secondary analysis from the requester's institution.\n\nData is strictly for non-commercial use."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}