Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-03 @ 8:32 AM
Study NCT ID:
NCT04113902
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2019-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and 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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Belief Model Scale for Human Papilloma Virus and Vaccine', 'timeFrame': 'three months', 'description': 'In the four-point Likert scale, each item is scored between "none = 1" and "too much = 4.. The lowest score is 14 and the highest score is 56.'}, {'measure': 'Human Papilloma Virus Knowledge Scale', 'timeFrame': 'three months', 'description': 'True 1 "points are given to the correct answers given by the participants to each item, and" 0 "points are given to wrong and undecided\' \'answers with incorrect answers. The lowest score that can be obtained from the scale is "0" and the highest is "10".'}], 'secondaryOutcomes': [{'measure': 'Human Papilloma Virus Knowledge Scale', 'timeFrame': 'three months', 'description': 'rue 1 "points are given to the correct answers given by the participants to each item, and" 0 "points are given to wrong and undecided\' \'answers with incorrect answers. The lowest score that can be obtained from the scale is "0" and the highest is "10".'}, {'measure': 'Health Belief Model Scale for Human Papilloma Virus and Vaccine', 'timeFrame': 'three months', 'description': 'In the four-point Likert scale, each item is scored between "none = 1" and "too much = 4.. The lowest score is 14 and the highest score is 56.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Papilloma Virus vaccine', 'Health education', 'Nursing', 'Adolescent Health'], 'conditions': ['Health Education']}, 'descriptionModule': {'briefSummary': 'Aim: To determine the effects of health education about Human Papilloma Virus infection and cervical cancer prevention on knowledge, attitudes, beliefs and behaviors of adolescent girls and their mothers.\n\nBackground: To combat with cervical cancer, it is urgent that prevention Human Papilloma Virus related disease all around the world.\n\nDesign: A randomized trial with a control group (n=108) and an intervention group (n=108).\n\nMethods: The study was applied between January to June 2019 in the two different adolescent outpatient clinics in Turkey. The outpatient clinics were randomly assigned as intervention and control groups by numbering and opaque and sealed envelopes. Based on the intention-to-treat principle, all participants were analyzed according to the group they were assigned to, regardless of whether they received the intervention or not. In addition to the routine clinical practice, the adolescent girls and their mothers who participated in the intervention group were given health education twice in the first interview and in the fifth week. Follow-up continued for 12 weeks. The adolescent girls and their mothers in the control group received routine clinical practice. The effects of health education were evaluated with Human Papilloma Virus Knowledge Scale and Health Belief Model Scale for Human Papilloma Virus and its Vaccination.\n\nImpact: Human Papilloma Virus vaccine, which has an important place in primary protection from cervical cancer, is expected to provide effective results by facilitating access to vaccine accompanied with health education.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be a girl between the ages of 9 and 18, to be a mother of a girl between the ages of 9 and 18, to be fluent in Turkish, to be literate\n\nExclusion Criteria:\n\nto be male, to have previously received Human Papilloma Virus vaccination, to have hearing, speech impairment and mental disorder, not to follow the study regularly, to use medication due to psychotic treatments, to be an adolescent with sexual experience'}, 'identificationModule': {'nctId': 'NCT04113902', 'briefTitle': 'The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': 'The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors of Adolescent Girls and Their Mothers: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2018/15- 18/331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Health education is given intervention group and 12 weeks follow up.', 'interventionNames': ['Behavioral: Health Education']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Control group takes standard health care and 12 weeks follow up.'}], 'interventions': [{'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'the adolescent girls and their mothers who participated in the intervention group were given health education twice in the first interview and in the fifth week. Follow-up continued for 12 weeks. The adolescent girls and their mothers in the control group received routine clinical practice. The effects of health education were evaluated with Human Papilloma Virus Knowledge Scale and Health Belief Model Scale for Human Papilloma Virus and its Vaccination.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Serpil Özdemir', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Serpil Ozdemir, PhD, RN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}