Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-28 @ 9:19 AM
Study NCT ID:
NCT05798559
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Hygiene Education in Mothers With Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006184', 'term': 'Habits'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D000070263', 'term': 'Sleep Hygiene'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial\n\nMothers of children with neurodevelopmental disorders will be included in the study.\n\nInclusion criteria for the study:\n\n* Having a child with a neurodevelopmental disorder\n* Be over 18 years old and literate\n* Having a child(s) of pre-school age (3-6 years old)\n* Communicating and collaborating\n\nIntervention and study group will be formed by simple randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Children's Sleep Habits Questionnaire", 'timeFrame': '1 month', 'description': 'Questionnaire that has been used in a number of studies to examine sleep behavior in young children. The Questionnaire includes items relating to a number of key sleep domains that encompass the major presenting clinical sleep complaints in this age group: bedtime behavior and sleep onset; sleep duration; anxiety around sleep; behavior occurring during sleep and night wakings; sleep-disordered breathing; parasomnias; and morning waking/daytime sleepiness.'}], 'secondaryOutcomes': [{'measure': 'Occupational Balance Questionnaire', 'timeFrame': '1 month', 'description': 'The purpose of the questionnaire is to measure satisfaction according to the amount and variety of daily activities of the individual and to define their occupational balance according to the obtained results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Hygiene', 'Neurodevelopmental Disorders'], 'conditions': ['Sleep', 'Habits', 'Neurodevelopmental Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are:\n\n* What is the importance of sleep routine and environment in children with neurodevelopmental disorders?\n* What kind of an effect does the awareness that mothers gain through sleep trainings have?\n\nParticipants will:\n\n* Evaluations will be applied to all participants\n* Divided into intervention and control groups\n* The intervention group will be given "Sleep Training" and followed up for about 1 month.\n* The results between the two groups will be compared\n\nResearchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'To be a mother', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a child with a neurodevelopmental disorder\n* Be over 18 years old and literate\n* Having a child(s) of pre-school age (3-6 years old)\n* Communicating and collaborating\n\nExclusion Criteria:\n\n* Having a neurological or psychiatric disease that prevents communication and cooperation'}, 'identificationModule': {'nctId': 'NCT05798559', 'briefTitle': 'Sleep Hygiene Education in Mothers With Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'CORAKCİ-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '* "Sleep Training" will be applied.\n* With the training, examples will be presented to mothers that they can apply in their daily lives.\n* 1 month will be followed', 'interventionNames': ['Behavioral: Sleep Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No training will be provided\n\nnote: "Sleep Training" will be given after the study is completed so that the control group is not victimized.'}], 'interventions': [{'name': 'Sleep Training', 'type': 'BEHAVIORAL', 'description': 'These are the trainings given by the researchers in order to regulate the sleep routine and environment. Content will be presented to improve sleep processes by arranging living habits.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34762', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Kardelen Yıldırım, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Gülşah Zengin, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Sultan Akel, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Sümeyye Sarışahin, Researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Beyzanur Demirci, Researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '9 months', 'ipdSharing': 'YES', 'description': 'It will be shared with researchers who offer suggestions to improve the the study being carried out', 'accessCriteria': 'Principal investigator will provide access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zeynep Çorakcı Yazıcıoğlu', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}