NCT04113902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

August 2, 2019

Last Update Submit

October 2, 2019

Conditions

Keywords

Human Papilloma Virus vaccineHealth educationNursingAdolescent Health

Outcome Measures

Primary Outcomes (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.

    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".

    three months

Secondary Outcomes (2)

  • Human Papilloma Virus Knowledge Scale

    three months

  • Health Belief Model Scale for Human Papilloma Virus and Vaccine

    three months

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: Health Education

control group

NO INTERVENTION

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

Interventions

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.

intervention group

Eligibility Criteria

Age9 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serpil Özdemir

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2019

First Posted

October 3, 2019

Study Start

December 18, 2018

Primary Completion

April 15, 2019

Study Completion

May 15, 2019

Last Updated

October 3, 2019

Record last verified: 2018-12

Locations