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

Primary Purpose

Health Education

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Health Education
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Education focused on measuring Human Papilloma Virus vaccine, Health education, Nursing, Adolescent Health

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

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

Sites / Locations

  • Serpil Özdemir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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".

Secondary Outcome Measures

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".
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.

Full Information

First Posted
August 2, 2019
Last Updated
October 2, 2019
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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1. Study Identification

Unique Protocol Identification Number
NCT04113902
Brief Title
The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Education
Keywords
Human Papilloma Virus vaccine, Health education, Nursing, Adolescent Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Health education is given intervention group and 12 weeks follow up.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group takes standard health care and 12 weeks follow up.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Belief Model Scale for Human Papilloma Virus and Vaccine
Description
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
Title
Human Papilloma Virus Knowledge Scale
Description
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 Outcome Measure Information:
Title
Human Papilloma Virus Knowledge Scale
Description
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
Title
Health Belief Model Scale for Human Papilloma Virus and Vaccine
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Serpil Özdemir
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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