Female TeachersNCT06464523
HPV Education, Early Diagnosis and Knowledge
A study testing Face to face education and Online education in people with Female Teachers, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of health education given to female teachers on HPV knowledge and screening test. The population of the study consisted of all female teachers belonging to the Bucak Directorate of National Education between September 2021 and March 2022. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Teachers
- What is being tested?
- Face to face education and Online education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 14 Mar 2022
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to volunteer to participate in the study,
- To be between the ages of 30-65,
- being a woman teacher,
- being married
- to be able to make video calls.
Who cannot join
- being pregnant or in the postnatal period,
- a history of cervical cancer,
- to have hysterectomy operation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, Bucak, 15000
About this study
Official title: The Effect of HPV Training on Early Diagnosis Screening and Knowledge Levels of Female Teachers
The aim of this study was to determine the effect of health education given to female teachers on HPV knowledge and screening test. The population of the study consisted of all female teachers belonging to the Bucak Directorate of National Education between September 2021 and March 2022. The sample of the study consisted of 144 healthy female teachers who were registered in the institutions affiliated to the District Directorate of National Education between the specified dates, met the inclusion criteria and volunteered to participate in the study. In this study area, with the assumption that the rate of cervical cancer screening test of 70% of the women in the Healthy Life Centre after the trainings would be considered significant, the effect size d=0.18 was calculated to include at least 98 women in 3 groups at 95% power and 0.05 error level. The calculation was performed with the 'G Power 3.1.9.2' package programme. In this context, the total sample of the study was determined as 156 participants, 52 in each group.
- Conditions
- Female Teachers
- Being tested
- Face to face education, Online education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to face educationBehavioural
In addition to the standard cervical cancer screening programme service, participants in this group received individual face-to-face health education on HPV and cervical cancer prevention through home visits and were given educational brochures. Participants in this group were interviewed a total of four times (four times face-to-face) during the research period.
Online educationBehavioural
In addition to the standard cervical cancer screening programme service, participants in this group received individual health education on HPV and cervical cancer prevention online via video call via WhatsApp application and were given a digital education brochure. Participants in this group were interviewed a total of four times (four times remotely) during the research process.
| Study group | Role | What they receive |
|---|---|---|
| Face to face education | Experimental | In addition to the standard cervical cancer screening programme service, participants in this group received individual face-to-face health education on HPV and cervical cancer prevention through home visits and were given educational brochures. Participants in this group were interviewed a total of four times (four times face-to-face) during the research process. Receives: Behavioral: Face to face education |
| Online education | Experimental | In addition to the standard cervical cancer screening programme service, participants in this group received individual health education on HPV and cervical cancer prevention online via video call via WhatsApp application and were given a digital education brochure. Participants in this group were interviewed a total of four times (four times remotely) during the research process. Receives: Behavioral: Online education |
| Control | No intervention | During the research process, the participants in the control group did not receive any intervention other than the standard cervical cancer screening programme service. During the research process, the participants in the control group were interviewed face-to-face twice. After the termination of the study, health education on protection against HPV and cervical cancer was provided to the volunteer participants by a method they specified and an educational brochure was given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papilloma Virus (HPV) Knowledge Scale:
HPV Knowledge Scale is a knowledge test developed by Waller et al. (2013) to determine the level of knowledge of individuals about HPV agent, HPV screening tests and vaccine. The scale, whose Turkish validity and reliability was conducted by Demir and Özdemir in 2019, has a total of 33 items. The HPV Knowledge Scale consists of four sub-dimensions: general HPV knowledge (items 1-16), HPV screening test knowledge (items 17-22), general HPV vaccine knowledge (items 23-27) and knowledge of the current HPV vaccination programme (items 28-33).
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start15 Sep 2021
- Primary completion10 Feb 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female TeachersStudies 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
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464523
- Sponsor's protocol ID
- GO 2020/71)
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
Bayik Temel A, Daghan S, Kaymakci S, Ozturk Donmez R, Arabaci Z. Effect of structured training programme on the knowledge and behaviors of breast and cervical cancer screening among the female teachers in Turkey. BMC Womens Health. 2017 Dec 7;17(1):123. doi: 10.1186/s12905-017-0478-8.
PubMed 29216918Kocaoz S, Ozcelik H, Talas MS, Akkaya F, Ozkul F, Kurtulus A, Unlu F. The Effect of Education on the Early Diagnosis of Breast and Cervix Cancer on the Women's Attitudes and Behaviors Regarding Participating in Screening Programs. J Cancer Educ. 2018 Aug;33(4):821-832. doi: 10.1007/s13187-017-1193-8.
PubMed 28285418Keten HS, Ucer H, Dalgaci AF, Isik O, Ercan O, Guvenc N. Knowledge, Attitude, and Behavior of Teachers Regarding HPV (Human Papillomavirus) and Vaccination. J Cancer Educ. 2021 Jun;36(3):584-590. doi: 10.1007/s13187-019-01668-2.
PubMed 31840211
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HPV Training on Early Diagnosis Screening and Knowledge Levels of Female Teachers
- ClinicalTrials.gov ID
- NCT06464523
- Acronym / sponsor ID
- GO 2020/71)
- Conditions
- Female Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 18 Jun 2024 (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.
The aim of this study was to determine the effect of health education given to female teachers on HPV knowledge and screening test. The population of the study consisted of all female teachers belonging to the Bucak Directorate of National Education between September 2021 and March 2022. The sample of the study consisted of 144 healthy female teachers who were registered in the institutions affiliated to the District Directorate of National Education between the specified dates, met the inclusion criteria and volunteered to participate in the study. In this study area, with the assumption that the rate of cervical cancer screening test of 70% of the women in the Healthy Life Centre after the trainings would be considered significant, the effect size d=0.18 was calculated to include at least 98 women in 3 groups at 95% power and 0.05 error level. The calculation was performed with the 'G Power 3.1.9.2' package programme. In this context, the total sample of the study was determined as 156 participants, 52 in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face to face education | Experimental | Behavioral: Face to face educationIn addition to the standard cervical cancer screening programme service, participants in this group received individual face-to-face health education on HPV and cervical cancer prevention through home visits and were given educational brochures. Participants in this group were interviewed a total of four times (four times face-to-face) during the research process. |
| Online education | Experimental | Behavioral: Online educationIn addition to the standard cervical cancer screening programme service, participants in this group received individual health education on HPV and cervical cancer prevention online via video call via WhatsApp application and were given a digital education brochure. Participants in this group were interviewed a total of four times (four times remotely) during the research process. |
| Control | No intervention | –During the research process, the participants in the control group did not receive any intervention other than the standard cervical cancer screening programme service. During the research process, the participants in the control group were interviewed face-to-face twice. After the termination of the study, health education on protection against HPV and cervical cancer was provided to the volunteer participants by a method they specified and an educational brochure was given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- to volunteer to participate in the study,
- To be between the ages of 30-65,
- being a woman teacher,
- being married
- to be able to make video calls.
Key exclusion criteria (3 listed)
- being pregnant or in the postnatal period,
- a history of cervical cancer,
- to have hysterectomy operation.
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 |
|---|---|---|
| Face to face educationIn addition to the standard cervical cancer screening programme service, participants in this group received individual face-to-face health education on HPV and cervical cancer prevention through home visits and were given educational brochures. Participants in this group were interviewed a total of four times (four times face-to-face) during the research period. | Behavioural | Face to face education |
| Online educationIn addition to the standard cervical cancer screening programme service, participants in this group received individual health education on HPV and cervical cancer prevention online via video call via WhatsApp application and were given a digital education brochure. Participants in this group were interviewed a total of four times (four times remotely) during the research process. | Behavioural | Online education |
Primary outcome
Human Papilloma Virus (HPV) Knowledge Scale:
Time frame: 5-10 minutes
HPV Knowledge Scale is a knowledge test developed by Waller et al. (2013) to determine the level of knowledge of individuals about HPV agent, HPV screening tests and vaccine. The scale, whose Turkish validity and reliability was conducted by Demir and Özdemir in 2019, has a total of 33 items. The HPV Knowledge Scale consists of four sub-dimensions: general HPV knowledge (items 1-16), HPV screening test knowledge (items 17-22), general HPV vaccine knowledge (items 23-27) and knowledge of the current HPV vaccination programme (items 28-33).
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 18 Jun 2024.
- Results publication: PubMed 29216918Bayik Temel A, Daghan S, Kaymakci S, Ozturk Donmez R, Arabaci Z. Effect of structured training programme on the knowledge and behaviors of breast and cervical cancer screening among the female teachers in Turkey. BMC Womens Health. 2017 Dec 7;17(1):123. doi: 10.1186/s12905-017-0478-8.
- Results publication: PubMed 28285418Kocaoz S, Ozcelik H, Talas MS, Akkaya F, Ozkul F, Kurtulus A, Unlu F. The Effect of Education on the Early Diagnosis of Breast and Cervix Cancer on the Women's Attitudes and Behaviors Regarding Participating in Screening Programs. J Cancer Educ. 2018 Aug;33(4):821-832. doi: 10.1007/s13187-017-1193-8.
- Results publication: PubMed 31840211Keten HS, Ucer H, Dalgaci AF, Isik O, Ercan O, Guvenc N. Knowledge, Attitude, and Behavior of Teachers Regarding HPV (Human Papillomavirus) and Vaccination. J Cancer Educ. 2021 Jun;36(3):584-590. doi: 10.1007/s13187-019-01668-2.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to face education and Online education in people with Female Teachers, run by Mehmet Akif Ersoy University 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 5 inclusion and 3 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 18 Jun 2024. 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?
Human Papilloma Virus (HPV) Knowledge Scale: (time frame: 5-10 minutes). 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 NCT06464523, which also lists 3 linked publications.
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 18 Jun 2024.