Vaccine HesitancyNCT07381088
Effect of Primary Care Education on Parents' Health-Related Perceptions and Attitudes
A study testing Structured Education Program in people with Vaccine Hesitancy and Health Education, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Health Education, Digital Health Literacy
- What is being tested?
- Structured Education Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 9 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Provided in Primary Health Care Services on Vaccine Hesitancy, Digital Vaccine Literacy, Eco-Anxiety, and Perceived Vulnerability to Diseases Among Parents of Children Aged 0-2 Years
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.
Read the detailed description
Childhood vaccination is one of the most effective and cost-efficient public health interventions for preventing infectious diseases. However, vaccine hesitancy among parents has emerged as a significant public health concern, particularly in the context of misinformation disseminated through digital media. Parents' attitudes toward vaccination are influenced not only by face-to-face communication with health professionals but also by their ability to access, evaluate, and use vaccine-related information from online sources. In addition, environmental concerns and climate-related health risks have increased levels of eco-anxiety, which may influence individuals' perceptions of vulnerability to diseases and health-related decision-making.
This study is designed as a quasi-experimental, pre-test-post-test, control-group study to evaluate the effect of a structured education program delivered in primary health care services on parents of children aged 0-2 years. The study will be conducted at a Family Health Center in Van, Türkiye. Parents who meet the inclusion criteria and provide written informed consent will be enrolled in the study.
Participants will be assigned to either an intervention group or a control group. Parents in the intervention group will receive a structured education program consisting of three face-to-face sessions delivered once per week, with each session lasting approximately 30-40 minutes. The education program includes: (1) childhood vaccines, vaccine hesitancy, and common misconceptions; (2) digital vaccine literacy, reliable information sources, and coping with misinformation; and (3) eco-anxiety, environmental health concerns, perceived vulnerability to diseases, and coping strategies. The control group will receive routine services provided by the Family Health Center and will not receive any additional educational intervention.
Data will be collected using validated self-report instruments administered before the intervention and 15 days after completion of the final education session. The primary outcomes include changes in vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases. Sociodemographic information will also be collected. All data will be collected through face-to-face interviews in a private setting, and participant confidentiality will be ensured by using coded identifiers instead of personal information.
The study aims to determine whether education provided within primary health care services can effectively improve parents' attitudes and perceptions related to vaccination and child health. The results are expected to inform future public health education strategies targeting parents during early childhood.
- Conditions
- Vaccine Hesitancy, Health Education, Digital Health Literacy, Eco-anxiety, Vulnerability to Disease, Childhood Immunization
- Being tested
- Structured Education Program
- Keywords
- Primary Health Care, Family Health Center, Parents, Children aged 0-2 years, Structured education program, Pretest-posttest, Misinformation, Health beliefs
- Medical subject headings
- Vaccination Hesitancy, Health Education, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 15 days after completion of the education program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jan 2026
- Primary completion20 Feb 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Faruk Yigit, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381088
- Sponsor's protocol ID
- 12.01.2026-228398
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Betsch C, Brewer NT, Brocard P, Davies P, Gaissmaier W, Haase N, Leask J, Renkewitz F, Renner B, Reyna VF, Rossmann C, Sachse K, Schachinger A, Siegrist M, Stryk M. Opportunities and challenges of Web 2.0 for vaccination decisions. Vaccine. 2012 May 28;30(25):3727-33. doi: 10.1016/j.vaccine.2012.02.025. Epub 2012 Feb 22.
PubMed 22365840World 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Provided in Primary Health Care Services on Vaccine Hesitancy, Digital Vaccine Literacy, Eco-Anxiety, and Perceived Vulnerability to Diseases Among Parents of Children Aged 0-2 Years
- ClinicalTrials.gov ID
- NCT07381088
- Acronym / sponsor ID
- 12.01.2026-228398
- Conditions
- Vaccine Hesitancy, Health Education, Digital Health Literacy, Eco-anxiety, Vulnerability to Disease, Childhood Immunization
- Keywords
- Primary Health Care, Family Health Center, Parents, Children aged 0-2 years, Structured education program, Pretest-posttest, Misinformation, Health beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood vaccination is one of the most effective and cost-efficient public health interventions for preventing infectious diseases. However, vaccine hesitancy among parents has emerged as a significant public health concern, particularly in the context of misinformation disseminated through digital media. Parents' attitudes toward vaccination are influenced not only by face-to-face communication with health professionals but also by their ability to access, evaluate, and use vaccine-related information from online sources. In addition, environmental concerns and climate-related health risks have increased levels of eco-anxiety, which may influence individuals' perceptions of vulnerability to diseases and health-related decision-making.
This study is designed as a quasi-experimental, pre-test-post-test, control-group study to evaluate the effect of a structured education program delivered in primary health care services on parents of children aged 0-2 years. The study will be conducted at a Family Health Center in Van, Türkiye. Parents who meet the inclusion criteria and provide written informed consent will be enrolled in the study.
Participants will be assigned to either an intervention group or a control group. Parents in the intervention group will receive a structured education program consisting of three face-to-face sessions delivered once per week, with each session lasting approximately 30-40 minutes. The education program includes: (1) childhood vaccines, vaccine hesitancy, and common misconceptions; (2) digital vaccine literacy, reliable information sources, and coping with misinformation; and (3) eco-anxiety, environmental health concerns, perceived vulnerability to diseases, and coping strategies. The control group will receive routine services provided by the Family Health Center and will not receive any additional educational intervention.
Data will be collected using validated self-report instruments administered before the intervention and 15 days after completion of the final education session. The primary outcomes include changes in vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases. Sociodemographic information will also be collected. All data will be collected through face-to-face interviews in a private setting, and participant confidentiality will be ensured by using coded identifiers instead of personal information.
The study aims to determine whether education provided within primary health care services can effectively improve parents' attitudes and perceptions related to vaccination and child health. The results are expected to inform future public health education strategies targeting parents during early childhood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Experimental): Structured Education | Experimental | Behavioral: Structured Education ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Education ProgramA 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. | Behavioural | Arm 1 (Experimental): Structured Education |
Primary outcome
Vaccine Hesitancy Level
Time frame: Baseline (pre-intervention) and 15 days after completion of the education program
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.
Digital Vaccine Literacy Level
Time frame: Baseline and 15 days after completion of the education program
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.
Eco-Anxiety Level
Time frame: Baseline and 15 days after completion of the education program
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.
Perceived Vulnerability to Disease
Time frame: Baseline and 15 days after completion of the education program
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Results publication: PubMed 22365840Betsch C, Brewer NT, Brocard P, Davies P, Gaissmaier W, Haase N, Leask J, Renkewitz F, Renner B, Reyna VF, Rossmann C, Sachse K, Schachinger A, Siegrist M, Stryk M. Opportunities and challenges of Web 2.0 for vaccination decisions. Vaccine. 2012 May 28;30(25):3727-33. doi: 10.1016/j.vaccine.2012.02.025. Epub 2012 Feb 22.
- Results publicationWorld 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
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Education Program in people with Vaccine Hesitancy and Health Education, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Hesitancy Level (time frame: Baseline (pre-intervention) and 15 days after completion of the education program). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.