Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT01310634
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-12-02', 'releaseDate': '2022-04-09'}], 'estimatedResultsFirstSubmitDate': '2022-04-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental anxiety symptoms', 'timeFrame': '3 weeks', 'description': 'Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonates', 'Parenting', 'Anxiety', 'Depression'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '23480505', 'type': 'RESULT', 'citation': 'Kong LP, Cui Y, Qiu YF, Han SP, Yu ZB, Guo XR. Anxiety and depression in parents of sick neonates: a hospital-based study. J Clin Nurs. 2013 Apr;22(7-8):1163-72. doi: 10.1111/jocn.12090.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.', 'detailedDescription': 'Parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. Parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in Chinese parents of hospitalized neonates. The aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a Chinese hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Speaks and reads Chinese\n* No severe handicapping conditions or mental diseases\n* Informed consent, no medical dispute\n* Infants born within 28 days to be cared in the neonatal ward for at least 24 hours\n\nExclusion Criteria:\n\n* Significant mental health history\n* Newborns died within a week after hospitalization'}, 'identificationModule': {'nctId': 'NCT01310634', 'briefTitle': 'Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates', 'orgStudyIdInfo': {'id': 'NMU-FY2011-236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comprehensive intervention', 'description': 'Parents of hospitalized neonates received Comprehensive intervention program.', 'interventionNames': ['Behavioral: Comprehensive intervention']}, {'type': 'OTHER', 'label': 'Conventional treatment', 'description': 'Usual educational program', 'interventionNames': ['Behavioral: Comprehensive intervention']}], 'interventions': [{'name': 'Comprehensive intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Comprehensive intervention program.'], 'description': 'Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.', 'armGroupLabels': ['Comprehensive intervention', 'Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Shuping Han, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhangbin Yu', 'investigatorAffiliation': 'Nanjing Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-09', 'type': 'RELEASE'}, {'date': '2022-12-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zhangbin Yu, Director, Nanjing Medical University'}}}}