Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:18 AM
Study NCT ID:
NCT07450703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Health Belief Model-Based Education Given to Mothers of Children Aged 9-15 on HPV Knowledge Level and Child Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083342', 'term': 'Health Belief Model'}], 'ancestors': [{'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008960', 'term': 'Models, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HPV Knowledge Score', 'timeFrame': '1 month after the education program', 'description': 'Health Belief Model Scale(HPVA-SIM): The scale consists of 14 items and four sub-dimensions: perceived benefit (Items 1-3), perceived sensitivity (Items 4-5), perceived seriousness (Items 6-9), and perceived barrier (Items 10-14). The Cronbach Alpha reliability coefficient was calculated as .78 for perceived benefit, .72 for perceived sensitivity, .78 for perceived severity, and .71 for perceived barrier in the sub-dimensions of the scale http://dx.doi.org/10.1016 HPV Knowledge Scale (HPV-KÖ): The HPV-KÖ includes three sub-dimensions of 29 items.Factor 1: General HPV knowledge, Factor 2: Knowledge of HPV screening tests, Factor 3: General HPV vaccine knowledge, Factor 4: Knowledge of the current HPV vaccination program. The Cronbach α value for the 29 items of the original scale was reported as 0.83, and the consistency of the scale was reported to be high for this value doi.org/10.4274/jtgga.galenos.2023.2022-10-9'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HUMAN PAPİLLOMA VIRUS', 'WOMEN HEALTH', 'VACCINE EDUCATİON'], 'conditions': ['Cancer , Healthy', 'HPV - Anogenital Human Papilloma Virus Infection', 'Health Belief Model']}, 'descriptionModule': {'briefSummary': "This study aims to examine the effects of education provided to mothers of children aged 9-15 within the framework of the Health Belief Model on mothers' knowledge, attitudes, and behaviors about Human Papillomavirus (HPV), and their willingness to have their children vaccinated against HPV. The study, designed with a randomized controlled experimental design, will be conducted at three different Family Health Centers in Gaziantep and will consist of both experimental and control groups. Mothers in the experimental group will receive a three-session visually supported education program prepared by Yıldız USCA, while the control group will receive routine information using HPV brochures from the Ministry of Health. Data collection tools include a personal information form, an HPV knowledge scale, and an HPV Health Belief Model scale."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Only mothers of children aged 9-15 years will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate and able to understand and speak Turkish\n* Mother of a child aged 9-15 years\n* Did not receive any HPV-related education in the past 6 months\n* Has not had HPV vaccination previously\n* Willing to participate voluntarily\n\nExclusion Criteria:\n\n* Presence of serious physical or cognitive impairment preventing participation\n* Refusal to provide informed consent\n* Already vaccinated against HPV\n* Already received HPV-related education within the last 6 months'}, 'identificationModule': {'nctId': 'NCT07450703', 'briefTitle': 'The Effect of the Health Belief Model-Based Education Given to Mothers of Children Aged 9-15 on HPV Knowledge Level and Child Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'The Effect of Health Belief Model-Based Education on Mothers of Children Aged 9-15 Years: Impact on HPV Knowledge Level and Child Vaccination', 'orgStudyIdInfo': {'id': 'Other Identifier'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAMILY HEALTH CENTER NO. 19', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}, {'type': 'EXPERIMENTAL', 'label': 'FAMILY HEALTH CENTER NO. 31', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}, {'type': 'EXPERIMENTAL', 'label': 'BURAK FAMILY HEALTH CENTER', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BURAK FAMILY HEALTH CENTER- control grup', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FAMILY HEALTH CENTER NO. 19- control grup', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FAMILY HEALTH CENTER NO. 31- control grup', 'interventionNames': ['Behavioral: HEALTH BELİEF MODEL']}], 'interventions': [{'name': 'HEALTH BELİEF MODEL', 'type': 'BEHAVIORAL', 'description': "In social psychology, the health belief model (HBM) is a psychological framework used to explain and predict individuals' potentially detrimental behaviors, attitudes and beliefs on their health. Developed in the 1950s by social psychologists at the United States Public Health Service, the model examines how perceptions of susceptibility to illness, the severity of health conditions, the benefits of preventive care, and barriers to healthcare influence behavior. The HBM is widely used in health behavior research and public health interventions to understand and promote engagement in health-protective behaviors", 'armGroupLabels': ['BURAK FAMILY HEALTH CENTER', 'BURAK FAMILY HEALTH CENTER- control grup', 'FAMILY HEALTH CENTER NO. 19', 'FAMILY HEALTH CENTER NO. 19- control grup', 'FAMILY HEALTH CENTER NO. 31', 'FAMILY HEALTH CENTER NO. 31- control grup']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'YILDIZ USCA', 'role': 'CONTACT', 'email': 'yildizusca@gmail.com', 'phone': '05066736770'}, {'name': 'HATİCE SERAP KOÇAK', 'role': 'CONTACT', 'email': 'stasdemirmeister@gmail.com', 'phone': '5325920089'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mrs.', 'investigatorFullName': 'Yildiz Usca', 'investigatorAffiliation': 'University of Gaziantep'}}}}