Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT04780633
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2021-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2021-02-21', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior.', 'timeFrame': '5 weeks', 'description': 'Linear regression analysis was performed to determine the factors that are independently effective in determining the Genital Hygiene Behavior Inventory (GHBI) score differences between the pre-test and post-test measurements of the women in the experimental group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genital hygiene behavior', "Women's health", 'Precede-Proceed model', 'Health education', 'Nursing'], 'conditions': ['Genital Infection Female']}, 'descriptionModule': {'briefSummary': 'The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018. Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group. The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group. The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks. The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study was conducted women who diagnosed with genital infections.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-49,\n* married,\n* At least primary school graduate,\n* No mental and communication problems,\n* No chronic disease,\n* Non-pregnant.\n\nExclusion Criteria:\n\n* Women who have entered menopause,\n* Women who had received any training on genital hygiene before'}, 'identificationModule': {'nctId': 'NCT04780633', 'briefTitle': 'PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Approval No: 2017-3/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precede-Proceed based Training Program', 'description': 'The experimental group is the group in which five training sessions interventions are applied.', 'interventionNames': ['Behavioral: Precede-Proceed based Training Program on Genital Hygiene Behaviors']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group is the group in which have no educational intervention.'}], 'interventions': [{'name': 'Precede-Proceed based Training Program on Genital Hygiene Behaviors', 'type': 'BEHAVIORAL', 'description': 'A Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group. The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week. At the end of the five-week training, a post-test was applied. In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended. At the end of the training, women were given a training booklet prepared by the researcher.', 'armGroupLabels': ['Precede-Proceed based Training Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35210', 'city': 'Izmir', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'Manolya Parlas', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manolya Parlas', 'investigatorAffiliation': 'Ataturk University'}}}}