Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06044220
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testicular Self-examination Training Given to Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013736', 'term': 'Testicular Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intervention and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Theory of Planned Behavior scale for testicular self-examination', 'timeFrame': 'three months', 'description': 'The Theory of Planned Behavior Scale on Testicular Self-Examination was applied as a follow-up test.'}], 'primaryOutcomes': [{'measure': 'survey form and Theory of Planned Behavior scale for testicular self-examination', 'timeFrame': 'one week', 'description': 'A survey form consisting of 21 questions, prepared by the researcher by reviewing the literature, and the Theory of Planned Behavior scale adapted to Turkish on Testicular Self-Examination were applied as a pretest.'}], 'secondaryOutcomes': [{'measure': 'Planned behavior theory scale related to testicular self-examination', 'timeFrame': 'one week', 'description': 'The Theory of Planned Behavior Scale on Testicular Self-Examination was applied as a posttest.\n\nThe minimum score to be obtained from the scale is 16 and the maximum is 112. Each dimension of the scale is evaluated separately, and as the score increases, positive behavior increases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testicular Cancer', 'Testicular self-exam', 'Planned behavior theory scale'], 'conditions': ['Testicular Neoplasm']}, 'descriptionModule': {'briefSummary': "The aim of this quasi-experimental control group study was to evaluate the effectiveness of testicular self-examination training given to male university students.\n\nHypotheses; H1a: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale intention sub-dimension scores related to Testicular Self-Examination will increase.\n\nH1b: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale attitude sub-dimension scores related to Testicular Self-Examination will increase.\n\nH1c: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale subjective norm sub-dimension scores on Testicular Self-Examination will increase.\n\nH1d: Immediately after the training and three months after the training, the experimental and control groups' Planned Behavior Theory scale perceived behavioral control sub-dimension scores will increase.\n\nH1e: Immediately after the training and three months after the training, the scores of the Planned Behavior Theory scale self-efficacy sub-dimension related to Testicular Self-Examination will increase in the experimental and control groups.\n\nH1f: Immediately after the training and three months after the training, the experimental and control group's Planned Behavior Theory scale total scores on Testicular Self-Examination will increase.\n\nA questionnaire will be administered to the participants before and after the training of male health promotion and testicular self-examination, and the retest will be filled after the reminders about the smallpox given for 3 months.\n\nThe researcher will compare the intervention and control group to see if the behavior of performing testicular self-examination regularly occurs.", 'detailedDescription': 'The data of the research were obtained from the students of Medical Documentation and Secretarial Program, Medical Promotion and Marketing Program and Optician Program affiliated to Bartın University Vocational School of Health Services Medical Services and Techniques Department between 27 December - 5 April 2022. The research was carried out in 3 stages.\n\npre-enterprise phase; Data collection forms were applied to n=102 participants who met the inclusion criteria and accepted the study (pretest). One participant with varicocele and one participant with a history of undescended testicles were excluded from the study. Experiment (n=51) and control (n=49) groups were formed by drawing lots between the primary and secondary education programs.\n\nInitiative stage; The "Male Health Promotion Training Program for Self-Testicular Examination" prepared by the researcher as a result of literature review (Power, et al. 2021; Taylor, 2004), was carried out in two sessions on different days in the same week. In the first session (30 minutes), the Anatomy of Male Reproductive Organs, Testicular Cancer and Risky Situations Caused by Testicular Cancer, in the second session (30 minutes) Testicular Self-Examination, the Importance of Regular Testicular Examination, and Fields of Expertise in Suspicion of Testicular Cancer were discussed. Data collection forms were applied for the second time immediately after the intervention (posttest). After the intervention, once a month for 3 months, the participants in the experimental group were reminded via mobile phone with the question "Have you done your Testicular Self Examination this month?".\n\nPost-intervention stage; At the end of the third month after the intervention, the data collection forms were applied again and the research process was completed (Follow-up).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being a continuous student at Vocational School of Health Services,\n2. Being over 18 years of age,\n3. Volunteering.\n\nExclusion Criteria:\n\n1. Those with a history of TC,\n2. Those with a family history of TC and\n3. Those with a history of testicular surgery such as undescended testicles, varicocelectomy and hydrocelectomy.'}, 'identificationModule': {'nctId': 'NCT06044220', 'briefTitle': 'Testicular Self-examination Training Given to Students', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Evaluation of the Effectiveness of Testicular Self-examination Training Given to Male University Students', 'orgStudyIdInfo': {'id': 'OKIRMIZIAY-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention group is given a 3-month reminder after the TSE training.', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'OTHER', 'label': 'control', 'description': 'No training or reminders are given to the control group', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention group was given training on male reproductive health and testicular self-examination after the pretest. Posttest was administered after the training. He was reminded to perform TSE for 3 months after the training. After the reminders, a follow-up test was applied.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Pretest and posttest were administered to the control group at the same time as the intervention group. After reminding the intervention group to perform TSI for 3 months, a follow-up test was performed in the control group.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78050', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Karabuk University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}], 'overallOfficials': [{'name': 'Gülcan KAR ŞEN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assist. Prof. Dr., Department of Nursing Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Öznur KIRMIZI AY', 'investigatorAffiliation': 'Karabuk University'}}}}