HPV VACCINATIONNCT04992741
Health Belief Model-based Education and Motivational Interview Regarding the HPV Vaccination Decision
A study testing education and motivational interview in people with HPV VACCINATION, run by Yasemin ATEŞEYAN at 1 site in Turkey (Türkiye).
Trial summary
This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers' knowledge, beliefs and attitudes towards HPV vaccine. . Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV VACCINATION
- What is being tested?
- education and motivational interview
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health belıef Model Based educatıon and motıvatıonal intervıewıng on Mothers' Knowledge, belıef and attıtudes Towards Hpv vaccıne
This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers' knowledge, beliefs and attitudes towards HPV vaccine. . The hypotheses of the research; The experimental group that received training and motivational interviews within the framework of SIM had higher knowledge and perception of HPV infection and vaccination in the posttest than the control group that did not receive any application.
Read the 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.
- Conditions
- HPV VACCINATION
- Being tested
- education and motivational interview
- Keywords
- HPV, Health Belief Model, Motivational Interview, Nursing
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and motivational interviewOther
The control group will remain subject to the routine process without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: education and motivational interview |
| other | No intervention | The control group will remain subject to the routine process without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures: Health Belief was assessed with the Health Belief Model Scale for Human Papilloma Virus Infection and Vaccination
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.
Measured: Change from before implementation, 1th week, 2th week and 3th week of practice
HPV information assessed with HPV information scale
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.
Measured: Change from before implementation, Change from before implementation, 1th week, 2th week and 3th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Sep 2020
- Primary completion1 Jan 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV VACCINATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasemin ATEŞEYAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasemin ATEŞEYAN, University of Gaziantep
- Investigators
- Yasemin Ateşeyan, Study chair, Turkey, Mersin University, Mersin, Yenişehir, Turkey, 33343
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992741
- Sponsor's protocol ID
- YASEMIN-001
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ateseyan Y, Gungormus Z. Web and theory-based motivational interviews in encouraging mothers for HPV vaccination of their daughters: A randomized controlled study. J Pediatr Nurs. 2024 Sep-Oct;78:e279-e288. doi: 10.1016/j.pedn.2024.07.016. Epub 2024 Jul 26.
PubMed 39060172
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health belıef Model Based educatıon and motıvatıonal intervıewıng on Mothers' Knowledge, belıef and attıtudes Towards Hpv vaccıne
- ClinicalTrials.gov ID
- NCT04992741
- Acronym / sponsor ID
- YASEMIN-001
- Conditions
- HPV VACCINATION
- Keywords
- HPV, Health Belief Model, Motivational Interview, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yasemin ATEŞEYANUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers' knowledge, beliefs and attitudes towards HPV vaccine. . The hypotheses of the research; The experimental group that received training and motivational interviews within the framework of SIM had higher knowledge and perception of HPV infection and vaccination in the posttest than the control group that did not receive any application.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: education and motivational interviewHealth 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. |
| other | No intervention | –The control group will remain subject to the routine process without any intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education and motivational interviewThe control group will remain subject to the routine process without any intervention. | Other | Experimental |
Primary outcome
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Derived from this study: PubMed 39060172Ateseyan Y, Gungormus Z. Web and theory-based motivational interviews in encouraging mothers for HPV vaccination of their daughters: A randomized controlled study. J Pediatr Nurs. 2024 Sep-Oct;78:e279-e288. doi: 10.1016/j.pedn.2024.07.016. Epub 2024 Jul 26.
Related trials for HPV VACCINATION
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Active, not recruitingPhase 4
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
HPV Infection
Active, not recruiting
Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care
Human Papillomavirus Infection
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Ateşeyan study chair
Turkey, Mersin University, Mersin, Yenişehir, Turkey, 33343
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and motivational interview in people with HPV VACCINATION, run by Yasemin ATEŞEYAN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.