Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04009902
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2019-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Depression and Sleep Disorders in Endometriosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Scale', 'timeFrame': '1 week', 'description': 'postoperative depression in endometriosis patients will be evaluated. Consists of 21 questions scored between 0-3.\n\nHIGH SCORE SHOWS TO HIGH DEPRESSION. (0-63 POINTS)'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '1 week', 'description': 'postoperative sleep disorders of endometriosis patients will be evaluated. Consists of 9 questions scored between 0-3.\n\nHIGH SCORE SHOWS BAD SLEEP QUALITY. (0-27 POINTS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Sleep', 'Depression']}, 'descriptionModule': {'briefSummary': "The aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation. The main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected. In this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period. As a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study group included patients with indications for operation and who agreed to test for depression and sleep disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-49 years of age with no known psychiatric disorder and\n* Endometriosis patients with indications for operation\n\nExclusion Criteria:\n\n* Patients receiving only medical treatment without any indication for operation,\n* those with a known psychiatric disease,\n* patients with sleep disorders due to another reason,\n* Patients over the age of 49, patients under the age of 18,\n* Patients with malignancy,\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT04009902', 'briefTitle': 'Evaluation of Depression and Sleep Disorders in Endometriosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively', 'orgStudyIdInfo': {'id': '2019.03.77'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Beck Depression Scale and Pittsburgh Sleep Quality Index', 'type': 'BEHAVIORAL', 'description': 'postoperative depression and sleep disorders in patients with endometriosis will be evaluated'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pınar Kadiroğulları', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, M.D, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}