Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-23 @ 8:16 PM
Study NCT ID:
NCT03930303
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D004108', 'term': 'Dilatation, Pathologic'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information', 'timeFrame': '30 minutes before and 10 minutes after multimedia education/verbal information', 'description': 'Total score for both State anxiety inventory and Trait anxiety score (Range: 20 to 80 points, higher values represent a worse outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dilatation and curettage', 'multimedia based education', 'anxiety'], 'conditions': ['Abnormal Uterine Bleeding', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\\&C). State-Trait Anxiety Inventory will be asked by the nursing staff before and after multimedia-based education or verbal information to all patients. Then the patients will undergo (D\\&C) at an office setting. The impact of MME on patient anxiety will be evaluated by statistical analysis.', 'detailedDescription': 'Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\\&C) with diagnostic or treatment purpose will be randomized to two intervention arms. Multimedia-education Group (MME group) and verbal information group (Control Group). Both groups will receive State-Trait Anxiety Inventory before and after education and then will undergo D\\&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing staff. Multimedia-based education will be carried out using a 5 minutes video explaining the details of D\\&C. D\\&C will be carried out at office setting by an experienced gynecologist under sedation and analgesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study\n\nExclusion Criteria:\n\nPsychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit'}, 'identificationModule': {'nctId': 'NCT03930303', 'briefTitle': 'Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting', 'orgStudyIdInfo': {'id': 'Gulseren1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multimedia Arm', 'interventionNames': ['Behavioral: Multimedia- based patient education']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Multimedia- based patient education', 'type': 'BEHAVIORAL', 'description': 'Patients will receive a 5 minutes video education before D\\&C', 'armGroupLabels': ['Multimedia Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34005', 'city': 'Istanbul', 'state': 'Please Enter the State Or Province', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Huseyin Kiyak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kanuni Sultan Suleyman Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gulseren Yilmaz', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}