NCT07381088

Brief Summary

This study aims to evaluate the effect of a structured education program delivered in primary health care settings on parents of children aged 0-2 years. The education focuses on childhood vaccination and related health perceptions. Parents will receive education covering childhood vaccines, vaccine hesitancy, evaluation of vaccine-related information obtained from digital sources, eco-anxiety, and perceived vulnerability to diseases. The study examines whether this education influences parents' levels of vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases. The findings are expected to contribute to the development of effective educational interventions in primary health care services to support informed parental decision-making regarding childhood vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2026

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

January 25, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Primary Health CareFamily Health CenterParentsChildren aged 0-2 yearsStructured education programPretest-posttestMisinformationHealth beliefs

Outcome Measures

Primary Outcomes (4)

  • Vaccine Hesitancy Level

    Change in parents' level of vaccine hesitancy measured using the Parent Vaccine Hesitancy Scale. The scale consists of 10 items and 2 subdimensions, with items 1, 2, 3, 4, 6, and 7 reverse-coded. It includes the Lack of Confidence subdimension (items 1, 2, 3, 4, 6, 7, and 8) and the Risks subdimension (items 5, 9, and 10). The scale is rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score is calculated by summing the item scores; higher total scores indicate lower levels of vaccine hesitancy.

    Baseline (pre-intervention) and 15 days after completion of the education program

  • Digital Vaccine Literacy Level

    Change in parents' digital vaccine literacy level measured using the Digital Vaccine Literacy Scale. The scale consists of a total of 7 items and 3 subdimensions: trust in and understanding of official information (items 1-2), trust in and understanding of information on social media (items 3-4), and evaluation and application of online vaccine information (items 5-7). Each item is rated on a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 7 to 28, with higher scores indicating a higher level of digital vaccine literacy.

    Baseline and 15 days after completion of the education program

  • Eco-Anxiety Level

    Change in parents' eco-anxiety level measured using the Hogg Eco-Anxiety Scale (HEAS-13) The scale consists of 13 items and four subdimensions (anxiety symptoms, rumination, behavioral symptoms, and concern about personal impact), with each item rated on a five-point Likert scale (0 = not at all, 1 = some days, 2 = most days, 3 = nearly every day). Higher scores on the scale indicate higher levels of eco-anxiety.

    Baseline and 15 days after completion of the education program

  • Perceived Vulnerability to Disease

    Change in parents' perceived vulnerability to disease measured using the Perceived Vulnerability to Disease Scale. The scale consists of a total of 15 items and two subdimensions: Perceived Infectability (items 2, 5, 6, 8, 10, 12, and 14) and Germ Aversion (items 1, 3, 4, 7, 9, 11, 13, and 15). Items 3, 5, 11, 12, 13, and 14 are reverse-scored. The total score obtainable from the scale ranges from 7 to 105. The scale is structured as a seven-point Likert type, ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate a higher perceived vulnerability to diseases.

    Baseline and 15 days after completion of the education program

Study Arms (2)

Arm 1 (Experimental): Structured Education

EXPERIMENTAL

Participants assigned to this arm will receive a structured, face-to-face education program delivered in a primary health care setting. The program consists of three weekly sessions, each lasting approximately 30-40 minutes. The education covers childhood vaccination, vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases.

Behavioral: Structured Education Program

Arm Type: Control Group (No Intervention)

NO INTERVENTION

Participants assigned to this arm will receive routine services provided by the Family Health Center. No additional educational intervention will be administered during the study period.

Interventions

A structured education program consisting of three face-to-face sessions delivered once per week in a primary health care setting. Each session lasts approximately 30-40 minutes and focuses on childhood vaccination, vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases.

Arm 1 (Experimental): Structured Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents who have at least one child aged 0-2 years
  • Attendance at the Van Tuşba Family Health Center
  • Ability to read and write in Turkish
  • Willingness to participate voluntarily in the study
  • Provision of written informed consent

You may not qualify if:

  • Individuals with a diagnosed psychiatric disorder
  • Individuals with cognitive or sensory impairments that prevent effective communication
  • Individuals who are unable to attend the education sessions
  • Individuals who do not complete the baseline assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University

Van, Van, 65100, Turkey (Türkiye)

Location

Related Publications (2)

  • Betsch C, Brewer NT, Brocard P, et al. Opportunities and challenges of Web 2.0 for vaccination decisions. Vaccine. 2018;36(25):3727-3733. doi:10.1016/j.vaccine.2018.02.025

    RESULT
  • World Health Organization. Ten threats to global health in 2019. World Health Organization; 2019. https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019

    RESULT

MeSH Terms

Conditions

Vaccination HesitancyHealth EducationCommunication

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study uses a quasi-experimental, pre-test-post-test, parallel-group design with an intervention group and a control group. Participants are assigned to either a structured education program delivered in primary health care settings or to routine care without additional education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor / Dr.

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

January 20, 2026

Primary Completion

February 20, 2026

Study Completion

March 9, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical considerations and the absence of explicit consent for data sharing in the informed consent process. Data will be used only for the purposes of the present study and reported in aggregate form to ensure participant confidentiality.

Locations