Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT05185466
Status:
UNKNOWN
Last Update Posted:
2022-01-19
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-15', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Attention', 'timeFrame': 'First Month', 'description': 'Psychomotor Vigilance Test'}, {'measure': 'Sleep Quality', 'timeFrame': 'First Month', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Sleepiness', 'timeFrame': 'First Month', 'description': 'Epworth Sleepiness Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Quality', 'Attention', 'Nurses']}, 'referencesModule': {'references': [{'pmid': '41188198', 'type': 'DERIVED', 'citation': 'Colak M, Esin MN. The Effect of Nurse-Led Self-Management Program on Psychomotor Vigilance and Sleep of Nurses Working Night Shifts: A Randomised Controlled Trial. Int J Nurs Pract. 2025 Dec;31(6):e70076. doi: 10.1111/ijn.70076.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurses working in shifts\n* Those between the ages of 18-65\n* Those who agree to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant and having suspicion of pregnancy\n* Having vision and hearing problems\n* Having diagnosed sleep disorder\n* Having a chronic disease that will prevent participation in the study\n* Having a diagnosed mental health problem'}, 'identificationModule': {'nctId': 'NCT05185466', 'briefTitle': 'Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'The Effect of Nurse-Supported Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses Working at Night Shift', 'orgStudyIdInfo': {'id': '61351342/Ocak 2021-88'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Experimental Group', 'interventionNames': ['Behavioral: Nurse-Supported Self Management Programme']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control Group'}], 'interventions': [{'name': 'Nurse-Supported Self Management Programme', 'type': 'BEHAVIORAL', 'description': 'Training and incentives to improve nutrition habits and sleep health.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul / Turkey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Merve Çolak, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'T.C. Üsküdar Üniversitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Merve Çolak', 'investigatorAffiliation': 'Uskudar University'}}}}