Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 4:17 PM
Study NCT ID:
NCT05595759
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Violence Against Women in Patients With Alcohol Substance Addiction Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-27', 'size': 162827, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-23T07:40', 'hasProtocol': True}, {'date': '2013-11-28', 'size': 174623, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-14T02:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'In this study, the names of the patients hospitalized in the two wards will be sorted and numbered in alphabetical order. After the numbering process, the patients will be selected to the experimental and control group by using the "https://www.randomizer.org/" site by an independent specialist.\n\nIn this study, the names of the patients hospitalized in the two wards will be sorted and numbered in alphabetical order. After the numbering process, the patients will be divided into an experimental and control group using the "https://www.randomizer.org/" site by an independent specialist.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-10-23', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pretest final test scores on violence against women', 'timeFrame': '10 day', 'description': 'Developed by Yalçın Kanbay in 2016, it is a 5-piece Likert type measurement tool consisting of two factors and 30 items. The scale has two sub-dimensions: "attitudes towards the body" and "attitudes towards identity". The total score of the scale is obtained by collecting the scores from two factors. On the scale, there are five answer options. In the scoring of the scale, each question is scored between 1-5. The high scores indicate that they are against violence against women, while the low scores indicate that they are not against violence against women. From the general scale, the lowest score is 30 and the highest score is 150. Kanbay found the Cronbach α value of the scale 0.86 for the overall scale. It is stated that the scale can be applied to individuals with at least primary school graduation and age between 15-65 years of age.'}, {'measure': 'Pretest final test scores', 'timeFrame': '10 days', 'description': 'Developed by Yalçın Kanbay in 2016, it is a 5-piece Likert type measurement tool consisting of two factors and 30 items. The scale has two sub-dimensions: "attitudes towards the body" and "attitudes towards identity". The total score of the scale is obtained by collecting the scores from two factors. On the scale, there are five answer options. In the scoring of the scale, each question is scored between 1-5. The high scores indicate that they are against violence against women, while the low scores indicate that they are not against violence against women. From the general scale, the lowest score is 30 and the highest score is 150. Kanbay found the Cronbach α value of the scale 0.86 for the overall scale. It is stated that the scale can be applied to individuals with at least primary school graduation and age between 15-65 years of age.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Violence', 'Women', 'Addiction', 'Creative drama'], 'conditions': ['Woman Abuse', 'Addiction', 'Violence', 'Men']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ASAM. (2022, July 5). What is the definition of addiction? . File:///C:/Users/Lenovo/Desktop/B0209701-2099-441a-92c3-Eb60c4a387cb.Pdf.'}, {'pmid': '30056376', 'type': 'BACKGROUND', 'citation': 'Bacchus LJ, Ranganathan M, Watts C, Devries K. Recent intimate partner violence against women and health: a systematic review and meta-analysis of cohort studies. BMJ Open. 2018 Jul 28;8(7):e019995. doi: 10.1136/bmjopen-2017-019995.'}, {'type': 'RESULT', 'citation': 'Aksoy, Y. D., Nacar, G., & Taşhan, S. T. (2018). Examine the attitudes toward spouse violence of health sciences faculty students Sağlık bilimleri fakültesi öğrencilerinin eş tarafından uygulanan şiddete ilişkin tutumları. Journal of Human Sciences, 15(2), 919-930'}, {'pmid': '40375196', 'type': 'DERIVED', 'citation': 'Tok HH, Kesgin MT. Effect of drama-education for alcohol/substance user on attitudes toward violence against women: randomized controlled design. BMC Public Health. 2025 May 15;25(1):1781. doi: 10.1186/s12889-025-23012-8.'}]}, 'descriptionModule': {'briefSummary': 'This study was planned as a randomized controlled trial in order to determine the effect of creative drama training for alcohol-substance dependent male patients on their attitudes towards violence against women.', 'detailedDescription': 'This study was planned as a randomized controlled trial in order to determine the effect of creative drama training for alcohol-substance dependent male patients on their attitudes towards violence against women.\n\nThe study was planned to be fully experimental. The participants to be included in the study will be selected from men who are followed up with a diagnosis of addiction in a mental health hospital. In the experimental group, male patients will be given violence against women training supported by creative drama five days a day. It will be used as an improved scale-measuring tool for women before and after the training. In the control group, the trainings applied in the service operation will be applied. It will be used as an improved scale-measuring tool for women before and after the training.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate,\n* Male inclusion,\n* Have reached the age of 18,\n* do not have an acute psychotic illness,\n* Patients without symptoms of delirium tremens or intense withdrawal made up the study group of this study.\n\nExclusion Criteria:\n\n* Illiterate,Woman,\n* Have an acute psychotic illness,\n* Delirium tremens or those with symptoms of intense withdrawal,\n* Patients who did not agree to participate in the study were not included in this study.'}, 'identificationModule': {'nctId': 'NCT05595759', 'briefTitle': 'Violence Against Women in Patients With Alcohol Substance Addiction Training', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'The Effect of Creative Drama Training for Alcohol-Substance Addicted Male Patients on Attitudes Towards Violence Against Women: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AİBÜ-HEM-HHT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Male patients with a diagnosis of alcohol and substance abuse', 'description': 'Male patients with a diagnosis of alcohol and substance abuse', 'interventionNames': ['Other: Violence against women education supported by creative drama']}, {'type': 'OTHER', 'label': 'Routine service operation', 'description': 'Male patients with a diagnosis of alcohol and substance abuse', 'interventionNames': ['Other: Routine service operation']}], 'interventions': [{'name': 'Violence against women education supported by creative drama', 'type': 'OTHER', 'description': 'Violence against women supported by creative drama training will be applied to male patients diagnosed with addiction every day for 5 days.', 'armGroupLabels': ['Male patients with a diagnosis of alcohol and substance abuse']}, {'name': 'Routine service operation', 'type': 'OTHER', 'description': 'No additional training will be applied to the control group and SAMBA trainings in the service operation will be applied.', 'armGroupLabels': ['Routine service operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'hülya ensari, dr', 'role': 'CONTACT', 'email': 'hulyaensari@gmail.com', 'phone': '3742752525', 'phoneExt': '4105'}, {'name': 'ayşegül koç, dr', 'role': 'CONTACT', 'email': 'agulkoc@hotmail.com', 'phone': '3742752525', 'phoneExt': '4114'}], 'facility': 'Mental Health and Diseases Hospital', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'centralContacts': [{'name': 'hülya ensari, doç.', 'role': 'CONTACT', 'email': 'hulyaensari@gmail.com', 'phone': '3742752525', 'phoneExt': '4104'}, {'name': 'Ayşegül koç, DR', 'role': 'CONTACT', 'email': 'agulkoc@hotmail.com', 'phone': '3742752525', 'phoneExt': '4114'}], 'overallOfficials': [{'name': 'hümeyra Hançer tok, msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abant Izzet Baysal University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'DATA WILL BE COLLECTED FOR 1 MONTH', 'ipdSharing': 'YES', 'description': 'WE WILL PREPARE THE STUDY AS A THESIS. THEN WE WILL TURN IT INTO A PUBLICATION IN AN INTERNATIONAL MAGAZINE', 'accessCriteria': 'CAN BE CONTACTED THROUGH YÖK-THESIS CENTER'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Otolaryngology', 'investigatorFullName': 'HUMEYRA HANCER TOK', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}