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CompletedNCT04113902Updated Oct 3, 2019

The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors

An interventional study of Health Education in Health Education, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed at 1 site in Turkey. Open to female participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2018, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
9 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Health Education

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Keywords

  • Human Papilloma Virus vaccine
  • Health education
  • Nursing
  • Adolescent Health
03

In context

Papilloma

234 studies on the registry are indexed under Papilloma; 28 are open to participants now.

This study's enrollment of 216 is above the median of 100 across 159 interventional studies indexed under Papilloma.

Browse Papilloma studies →

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (actual)

Study arms

  • Experimental
    intervention group

    Health education is given intervention group and 12 weeks follow up.

    Behavioral: Health Education

  • No intervention
    control group

    Control group takes standard health care and 12 weeks follow up.

Interventions

  • BehavioralHealth Education

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: three months

  2. 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".

    Time frame: three months

Secondary outcomes

  1. 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".

    Time frame: three months

  2. 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.

    Time frame: three months

07

Study locations

1 site
  • Serpil Özdemir
    Ankara, 06010, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04113902
Lead sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party
Serpil Ozdemir, PhD, RN (Assistant Professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted
Oct 3, 2019
Start date
Dec 18, 2018
Primary completion
Apr 15, 2019
Completion
May 15, 2019
Last update
Oct 3, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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