Health EducationNCT04113902
The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors
A study testing Health Education in people with Health Education, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Education
- What is being tested?
- Health Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2018to 15 May 2019
- 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 9 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To 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
Who cannot join
- to 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Background: To combat with cervical cancer, it is urgent that prevention Human Papilloma Virus related disease all around the world.
Read more
Design: A randomized trial with a control group (n=108) and an intervention group (n=108).
Methods: 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.
Impact: 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.
- Conditions
- Health Education
- Being tested
- Health Education
- Keywords
- Human Papilloma Virus vaccine, Health education, Nursing, Adolescent Health
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Health education is given intervention group and 12 weeks follow up. Receives: Behavioral: Health Education |
| control group | No intervention | Control group takes standard health care and 12 weeks follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Belief Model Scale for Human Papilloma Virus and Vaccine
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.
Measured: three months
Human Papilloma Virus Knowledge Scale
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".
Measured: three months
Secondary outcomes (2)
Human Papilloma Virus Knowledge Scale
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".
Measured: three months
Health Belief Model Scale for Human Papilloma Virus and Vaccine
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start18 Dec 2018
- Primary completion15 Apr 2019
- Study completion15 May 2019
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 Health EducationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Ozdemir, PhD, RN, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113902
- Sponsor's protocol ID
- 2018/15- 18/331
- Status last verified
- Dec 2018
- First submitted
- 2 Aug 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozdemir S, Caglayan R. Health education on HPV vaccination and cervical cancer prevention: A randomised controlled trial on knowledge, attitudes, beliefs, and behaviours. J Pak Med Assoc. 2026 Feb;76(2):140-150. doi: 10.47391/JPMA.22482.
PubMed 41830346
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04113902
- Acronym / sponsor ID
- 2018/15- 18/331
- Conditions
- Health Education
- Keywords
- Human Papilloma Virus vaccine, Health education, Nursing, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 3 Oct 2019 (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.
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.
Background: To combat with cervical cancer, it is urgent that prevention Human Papilloma Virus related disease all around the world.
Design: A randomized trial with a control group (n=108) and an intervention group (n=108).
Methods: 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.
Impact: 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Health EducationHealth education is given intervention group and 12 weeks follow up. |
| control group | No intervention | –Control group takes standard health care and 12 weeks follow up. |
Who may qualify
- Ages
- 9 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- To 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
Key exclusion criteria (1 listed)
- to 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
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 |
|---|---|---|
| Health Educationthe 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. | Behavioural | intervention group |
Primary outcome
Health Belief Model Scale for Human Papilloma Virus and Vaccine
Time frame: three months
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.
Human Papilloma Virus Knowledge Scale
Time frame: three months
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".
2 secondary outcomes
Human Papilloma Virus Knowledge Scale
Time frame: three months
Health Belief Model Scale for Human Papilloma Virus and Vaccine
Time frame: three months
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 3 Oct 2019.
- Derived from this study: PubMed 41830346Ozdemir S, Caglayan R. Health education on HPV vaccination and cervical cancer prevention: A randomised controlled trial on knowledge, attitudes, beliefs, and behaviours. J Pak Med Assoc. 2026 Feb;76(2):140-150. doi: 10.47391/JPMA.22482.
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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 Health Education in people with Health Education, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 1 inclusion and 1 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 3 Oct 2019. 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?
Health Belief Model Scale for Human Papilloma Virus and Vaccine (time frame: three months). 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 NCT04113902, 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 3 Oct 2019.