- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447245
Parent Education About Human Papillomavirus (HPV) ((HPV))
Effect of a Health Belief Model-Based Parent Education Intervention on Human Papillomavirus Knowledge and Vaccination Intention: A Randomized Controlled Trial
Human papillomavirus (HPV) vaccination is an effective strategy for preventing HPV-related diseases; however, parental knowledge and vaccination intention may influence vaccine uptake among children and adolescents. This randomized controlled trial evaluated the effect of a Health Belief Model (HBM)-based parent education intervention on HPV knowledge and HPV vaccination intention among parents of children aged 9-14 years.
A total of 64 parents were enrolled and randomly assigned to an intervention group (n=32) or a control group (n=32). Following baseline assessment, the intervention group received a single, approximately 40-minute, face-to-face, nurse-led educational session based on the constructs of the Health Belief Model. The control group received no educational intervention during the five-week comparison period.
HPV knowledge and vaccination intention were assessed at baseline and five weeks later. After completion of the five-week assessment, the control group received the same educational session for ethical reasons.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This parallel-group randomized controlled trial was conducted among parents of children aged 9-14 years. A total of 64 eligible parents completed the baseline assessment and were allocated to two parallel groups, with 32 participants in the intervention group and 32 participants in the control group.
Following the baseline assessment, participants assigned to the intervention group received a single, face-to-face, nurse-led educational session based on the Health Belief Model. The approximately 40-minute session addressed HPV transmission, HPV-related diseases and cancers, HPV vaccination, vaccine effectiveness, recommended vaccination schedules, screening, common misconceptions, and barriers to vaccination. The educational content was structured according to the Health Belief Model constructs of perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.
Participants in both groups were invited to return five weeks after the baseline assessment. To reduce interaction between groups during follow-up assessment, the intervention and control groups attended at different times on the same day. The intervention group attended first, followed by the control group. HPV knowledge and vaccination intention were reassessed at the five-week follow-up.
All 32 participants in the intervention group completed the follow-up assessment. Of the 32 participants assigned to the control group, 30 completed the follow-up assessment. After completion of the follow-up assessment, participants in the control group received the same educational session provided to the intervention group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey (Türkiye), 42020
- Özel Bilgi Dünyası Etüt Merkezi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Parent aged 18-49 years
- Being a parent of a child aged 9-14 years
- Being able to read and write in Turkish
- Having no hearing or communication problems that would prevent participation in the educational session
- Providing voluntary informed consent to participate in the study
Exclusion Criteria:
• Having a child who had received any dose of the HPV vaccine before enrollment in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parent group that will receive HPV training
Participants assigned to the intervention group received a single, face-to-face, nurse-led educational session based on the Health Belief Model after completion of the baseline assessment.
The session lasted approximately 40 minutes and included information on HPV transmission, HPV-related cancers, HPV vaccination, vaccine effectiveness, vaccination schedules, screening, and common misconceptions.
Participants were invited to return five weeks later for post-intervention assessment.
|
Participants assigned to the intervention group received a single, face-to-face, nurse-led educational session based on the Health Belief Model after completion of the baseline assessment.
The approximately 40-minute session addressed HPV transmission, HPV-related cancers, HPV vaccination, vaccine effectiveness, recommended vaccination schedules, screening, and common misconceptions.
The educational content was structured according to the Health Belief Model constructs, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.
Participants were invited to return five weeks later for post-intervention assessment.
|
|
No Intervention: Control group to receive HPV training
Participants assigned to the control group completed the baseline assessment and received no educational intervention during the five-week comparison period.
They returned five weeks later for post-intervention assessment.
After completion of the post-intervention assessment, they received the same educational session as the intervention group for ethical reasons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Human Papillomavirus Knowledge Scale (HPV-KS)
Time Frame: Baseline and 5 weeks
|
HPV knowledge was assessed using the 33-item Human Papillomavirus Knowledge Scale (HPV-KS).
The scale includes items assessing general HPV knowledge, HPV testing knowledge, and HPV vaccination knowledge.
Items are answered as "Yes," "No," or "I don't know."
Each correct response is scored as 1, whereas incorrect and "I don't know" responses are scored as 0. Total scores range from 0 to 33, with higher scores indicating greater HPV-related knowledge.
|
Baseline and 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV Vaccination Intention
Time Frame: Baseline and 5 weeks
|
Parents' intention to vaccinate their child against HPV was assessed using the question, "Would you consider vaccinating your child against HPV?" Responses were recorded as "Yes" or "No."
Vaccination intention was assessed at baseline and again five weeks after the intervention.
|
Baseline and 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Pathological Conditions, Signs and Symptoms
- Papillomavirus Infections
Other Study ID Numbers
- KTO Karatay Ünivesitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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