- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04992741
Health Belief Model-based Education and Motivational Interview Regarding the HPV Vaccination Decision
The Effect of Health belıef Model Based educatıon and motıvatıonal intervıewıng on Mothers' Knowledge, belıef and attıtudes Towards Hpv vaccıne
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods: In order to determine the sample size of the study, it was planned to work with a total of 54 patients, at least 27 patients in each group, in the power analysis performed by taking the reference information of the statistician and previous studies, and the study was completed with a total of 63 people (31 in the experimental group, 32 in the control group). The Health Belief Model-based motivational interview will be conducted over the phone and will last 15-20 minutes. One week after each motivational interview, a questionnaire and scale form will be applied to the mothers. After the third meeting, the study will be completed by applying the questionnaire and scale forms. Finally, the questionnaire for measurement will be filled and the research will be completed.
The control group will be subjected to routine processing without any intervention. Questionnaire forms were applied to the control group simultaneously with the experimental group. At the end of the study, a single-session motivational interview will be held by the researcher, since the patients in the control group have equal ethical rights. The primary result expected from the study is that mothers' perceptions of the benefit, sensitivity and severity of HPV vaccine increase, and their perception of barriers decreases. The secondary result expected from the study is the increase in mothers' knowledge about HPV infection and vaccination. The tertiary expected outcome of the study is that the mother sees her daughter at risk of HPV infection and decides to have her daughter vaccinated against HPV.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey, 33343
- Mersin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Those who live in Mersin and are female students in two high schools determined between 15.03.2020 and 15.06.2021.,
- Daughter not vaccinated against HPV,
- Undecided about getting her daughter vaccinated against HPV,
- Who doesn't plan to have their daughter vaccinated against HPV,
- who agreed to participate in the research,
- Literate,
- Can speak Turkish,,
- Having no hearing or sight impairment that will prevent communication,,
- Able to talk on the phone and use whatsapp,,
- Participants without a diagnosed psychiatric problem were included in the study..
Exclusion Criteria:
- Having her daughter vaccinated against HPV,
- Thinking of getting her daughter vaccinated against HPV,
- Who refused to participate in the research,
- Illiterate,
- Don't speak Turkish,
- People with hearing or sight impairments that may interfere with communication,
- Can't talk on the phone and can't use whatsapp,
- Participants with diagnosed psychiatric problems were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental
Health Belief Model Based Motivational Interview Group The application will be made by the researcher who has been trained in motivational interviewing techniques.
Motivational interviews based on Health Belief Model will be made by telephone to mothers who have daughters studying in high school.
There will be 3 interviews with mothers based on the benefits, barriers, sensitivity and severity perception structures of the Health Belief Model regarding HPV infection and vaccination, and each interview will last 15-20 minutes.
One week after each interview, the questionnaire/scale forms will be sent via whatsapp and applied.
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The control group will remain subject to the routine process without any intervention.
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No Intervention: other
The control group will remain subject to the routine process without any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary Outcome Measures: Health Belief was assessed with the Health Belief Model Scale for Human Papilloma Virus Infection and Vaccination
Time Frame: Change from before implementation, 1th week, 2th week and 3th week of practice
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It was developed by Kim (2012) to measure health beliefs towards the HPV vaccine.
The scale consists of 4 subscales: benefits (1-3 items), perceived disability (10-14 items), sensitivity (4-5 items), severity (6-9 items) and a total of 14 items.
The scale items are interpreted as four-point likert type, with 1 as "not at all", 2 as "a little", 3 as "quite a lot", and 4 as "a lot".
The total score range of the scale is 14-56.
As the scale score increases, the perception also increases.
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Change from before implementation, 1th week, 2th week and 3th week of practice
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HPV information assessed with HPV information scale
Time Frame: Change from before implementation, Change from before implementation, 1th week, 2th week and 3th week of practice
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The HPV knowledge scale was developed by Waller et al (2013) to measure the knowledge levels of individuals about HPV, HPV vaccine and screening tests.
In the scale with a total of 33 items; It consists of four sub-dimensions: general HPV information (1-16 items), HPV screening test information (17-22 items), general HPV vaccine information (23-27 items) and information about the current HPV vaccination program (28-33 items).
Participants are expected to mark each item of the scale as "Yes", "No" and "I don't know".
In the evaluation phase, each correct answer is scored with=1, while incorrect answers and I don't know are scored with=0.
In order to avoid bias in the answers, the correct and incorrect answers were mixed as in the original scale.
The total score to be obtained from the scale is between 0-33, and a high score indicates a high level of knowledge about HPV, HPV screening tests and HPV vaccine.
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Change from before implementation, Change from before implementation, 1th week, 2th week and 3th week of practice
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yasemin Ateşeyan, Turkey, Mersin University, Mersin, Yenişehir, Turkey, 33343
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YASEMIN-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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