Childhood ImmunizationNCT07324356
Effects of Individual and Group Education on Mothers' Attitudes and Decisions About Childhood Vaccination
A study testing Vaccination attitude in people with Childhood Immunization, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their vaccination attitudes and decisions. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Childhood Immunization
- What is being tested?
- Vaccination attitude
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being registered at Rumeli Family Health Center, Bağcılar, Istanbul
- Ability to speak and understand Turkish
- Ability to read and write
- Having a child within the age range covered by the national vaccination schedule (0-13 years)
- Being 18 years of age or older
- Willingness to participate in the study
Who cannot join
- Not attending one or more of the educational sessions
- Participating in any training other than the vaccination education program
- Failing to complete the data collection forms in full
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Rumeli Aile Sağlığı Merkezi
Istanbul, Bağcılar, 34200
About this study
Official title: The Effect of Face-to-Face and Group Education Given to Mothers on Their Attitudes and Decisions Regarding Childhood Vaccinations
This study was planned to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their vaccination attitudes and decisions. It is believed that the education provided will help eliminate mothers' misconceptions and false beliefs about vaccines in the short term, and contribute to positive changes in their attitudes and decisions regarding vaccination. Moreover, it is anticipated that in the long term, this intervention will contribute to achieving better immunization rates and protecting children from vaccine-preventable diseases. This study is also important in terms of emphasizing the role of midwives in protecting and improving infant and community health.This study will be carried out as a randomized controlled experimental study to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. Mothers who have children within the age range in which childhood vaccinations are administered will be contacted and informed about the purpose and scope of the study, and they will be asked whether they agree to participate. Mothers who consent to participate will be randomly assigned into three groups using computer-assisted randomization (https://www.random.org/
): Group 1: Mothers receiving individual face-to-face education, Group 2: Mothers receiving group education, and Group 3: Control group (receiving the routine unit-based information).
Read the detailed description
Experimental Group 1
(Group 1: Mothers Receiving Individual Face-to-Face Education)
After identifying the mothers to whom the education will be provided, they will be contacted by phone using their contact information and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC). Before the education, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first session of individual face-to-face education will then be conducted using previously prepared educational content. An educational brochure related to the content of the training will be given to the mothers. After the education session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
The second education session will be conducted two weeks later. In this session, the previously provided information will be reviewed and reinforced, and the mothers' questions will be answered. Following the session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
Experimental Group 2
(Group 2: Mothers Receiving Group Education)
After identifying the mothers to whom the education will be provided, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the FHC to attend group education sessions scheduled at appropriate dates and times. Before the education, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first session of the group education will be conducted using previously prepared educational content. An educational brochure related to the content of the training will be given to the mothers. After the education session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
The second education session will be conducted two weeks later. In this session, the previously provided information will be reviewed and reinforced, and the mothers' questions will be answered. Following the session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
Control Group
(Group 3: Mothers Receiving Routine Education)
After identifying the mothers who will receive routine education at the FHC, they will be contacted by phone and informed about the study. The mothers will be invited to the FHC, where the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered prior to the education.
Subsequently, the routine education provided by the FHC will be delivered, and an educational brochure will also be given to the mothers in the control group. After the education, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
Two weeks later, the mothers will be invited to the FHC again, the routine education will be repeated, and after the education, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
- Conditions
- Childhood Immunization
- Being tested
- Vaccination attitude
- Keywords
- Vaccine hesitancy, Vaccination attitude, Vaccine education
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination attitudeBehavioural
This study was planned to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. It is thought that the education provided will help eliminate mothers' misconceptions and false beliefs about vaccines in the short term and contribute to positive changes in their attitudes and decisions regarding vaccination. Moreover, it is anticipated that, in the long term, this intervention will contribute to achieving better immunization rates and protecting children from vaccine-preventable diseases. This study is also important in terms of emphasizing the midwife's role in protecting and improving infant and community health.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Mothers receiving individual face-to-face education | Experimental | After identifying eligible mothers, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC). Before the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first session of individual face-to-face education will be conducted using pre-prepared training content. An educational brochure related to the training content will be provided. After the session, the same forms and scales will be re-administered.
Two weeks later, a second individual training session will be conducted to review and reinforce the previous education, and mothers' questions will be answered. Following the session, the data collection form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. Receives: Behavioral: Vaccination attitude |
| Group 2: Mothers receiving group education | Experimental | After identifying eligible mothers, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC) on scheduled dates for group training sessions. Before the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first group education session will be conducted using pre-prepared training content, and an educational brochure will be provided. After the session, the same forms and scales will be re-administered.
Two weeks later, a second group education session will be conducted to review and reinforce the previous education, and participants' questions will be answered. After the session, the data collection form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. Receives: Behavioral: Vaccination attitude |
| Group 3: Control group (receiving the routine unit-based information) | No intervention | After identifying mothers who will receive routine informational training at the Family Health Center (FHC), they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the FHC. Before the routine training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered. Routine training provided by the FHC will then be conducted. After the training, the same data collection form and scales will be re-administered. Two weeks later, participants will be invited again to receive routine training once more, and following the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Opposition Scale
The total score of the long form ranges from 21 to 105, while the total score of the short form ranges from 12 to 60. Higher scores on the scale indicate higher levels of vaccine hesitancy among participants."The long form of the scale demonstrated high internal consistency (Cronbach's alpha = 0.905)."
Measured: 6 month
Vaccine Attitudes Scale
Each item on the Vaccine Attitudes Scale is scored as agree = 1, undecided = 2, and disagree = 3. The total score is calculated by summing the item scores. The possible total score ranges from 11 to 33, where a score of 11 indicates a positive parental attitude toward vaccination, and a score of 33 indicates a negative attitude toward vaccination.
The scale does not have a cut-off point. As the total score increases, parental vaccine hesitancy increases, reflecting a more negative attitude toward vaccination.
"The Turkish version of the scale demonstrated acceptable internal consistency (Cronbach's alpha = 0.66)."
Measured: 6 month
Data Collection Form
This form was developed by the researcher and the advisor based on the relevant literature (Yorulmaz et al., 2024; Ünsal, 2020; Yiğit et al., 2020; Hazır, 2018) and consists of 27 questions. It will be used in the study to determine mothers' demographic and descriptive characteristics and their decisions regarding vaccination.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Nov 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ImmunizationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be carried out as a randomized controlled experimental study to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. Mothers who have children within the age range in which childhood vaccinations are administered will be contacted and informed about the purpose and scope of the study, and they will be asked whether they agree to participate. Mothers who consent to participate will be randomly assigned into three groups using computer-assisted randomization (https://www.random.org/ ): Group 1: Mothers receiving individual face-to-face education, Group 2: Mothers receiving group education, and Group 3: Control group (receiving the routine unit-based information).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Çolak, Istanbul University - Cerrahpasa
- Investigators
- Songül ÇOLAK, Principal investigator, Istanbul Provincial Directorate of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324356
- Sponsor's protocol ID
- Istanbul University-Cerrahpa
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Face-to-Face and Group Education Given to Mothers on Their Attitudes and Decisions Regarding Childhood Vaccinations
- ClinicalTrials.gov ID
- NCT07324356
- Acronym / sponsor ID
- Istanbul University-Cerrahpa
- Conditions
- Childhood Immunization
- Keywords
- Vaccine hesitancy, Vaccination attitude, Vaccine education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 7 Jan 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 was planned to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their vaccination attitudes and decisions. It is believed that the education provided will help eliminate mothers' misconceptions and false beliefs about vaccines in the short term, and contribute to positive changes in their attitudes and decisions regarding vaccination. Moreover, it is anticipated that in the long term, this intervention will contribute to achieving better immunization rates and protecting children from vaccine-preventable diseases. This study is also important in terms of emphasizing the role of midwives in protecting and improving infant and community health.This study will be carried out as a randomized controlled experimental study to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. Mothers who have children within the age range in which childhood vaccinations are administered will be contacted and informed about the purpose and scope of the study, and they will be asked whether they agree to participate. Mothers who consent to participate will be randomly assigned into three groups using computer-assisted randomization (https://www.random.org/
): Group 1: Mothers receiving individual face-to-face education, Group 2: Mothers receiving group education, and Group 3: Control group (receiving the routine unit-based information).
Detailed description
Experimental Group 1
(Group 1: Mothers Receiving Individual Face-to-Face Education)
After identifying the mothers to whom the education will be provided, they will be contacted by phone using their contact information and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC). Before the education, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first session of individual face-to-face education will then be conducted using previously prepared educational content. An educational brochure related to the content of the training will be given to the mothers. After the education session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
The second education session will be conducted two weeks later. In this session, the previously provided information will be reviewed and reinforced, and the mothers' questions will be answered. Following the session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
Experimental Group 2
(Group 2: Mothers Receiving Group Education)
After identifying the mothers to whom the education will be provided, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the FHC to attend group education sessions scheduled at appropriate dates and times. Before the education, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered.
The first session of the group education will be conducted using previously prepared educational content. An educational brochure related to the content of the training will be given to the mothers. After the education session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
The second education session will be conducted two weeks later. In this session, the previously provided information will be reviewed and reinforced, and the mothers' questions will be answered. Following the session, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
Control Group
(Group 3: Mothers Receiving Routine Education)
After identifying the mothers who will receive routine education at the FHC, they will be contacted by phone and informed about the study. The mothers will be invited to the FHC, where the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered prior to the education.
Subsequently, the routine education provided by the FHC will be delivered, and an educational brochure will also be given to the mothers in the control group. After the education, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be administered again.
Two weeks later, the mothers will be invited to the FHC again, the routine education will be repeated, and after the education, the data collection form, vaccine attitudes scale, and vaccine hesitancy scale will be re-administered.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study will be carried out as a randomized controlled experimental study to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. Mothers who have children within the age range in which childhood vaccinations are administered will be contacted and informed about the purpose and scope of the study, and they will be asked whether they agree to participate. Mothers who consent to participate will be randomly assigned into three groups using computer-assisted randomization (https://www.random.org/ ): Group 1: Mothers receiving individual face-to-face education, Group 2: Mothers receiving group education, and Group 3: Control group (receiving the routine unit-based information).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Mothers receiving individual face-to-face education | Experimental | Behavioral: Vaccination attitudeAfter identifying eligible mothers, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC). Before the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered. The first session of individual face-to-face education will be conducted using pre-prepared training content. An educational brochure related to the training content will be provided. After the session, the same forms and scales will be re-administered. Two weeks later, a second individual training session will be conducted to review and reinforce the previous education, and mothers' questions will be answered. Following the session, the data collection form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. |
| Group 2: Mothers receiving group education | Experimental | Behavioral: Vaccination attitudeAfter identifying eligible mothers, they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the Family Health Center (FHC) on scheduled dates for group training sessions. Before the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered. The first group education session will be conducted using pre-prepared training content, and an educational brochure will be provided. After the session, the same forms and scales will be re-administered. Two weeks later, a second group education session will be conducted to review and reinforce the previous education, and participants' questions will be answered. After the session, the data collection form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. |
| Group 3: Control group (receiving the routine unit-based information) | No intervention | –After identifying mothers who will receive routine informational training at the Family Health Center (FHC), they will be contacted by phone and informed about the study. Mothers who agree to participate will be invited to the FHC. Before the routine training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered. Routine training provided by the FHC will then be conducted. After the training, the same data collection form and scales will be re-administered. Two weeks later, participants will be invited again to receive routine training once more, and following the training, the Data Collection Form, Vaccine Attitudes Scale, and Vaccine Hesitancy Scale will be administered again. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being registered at Rumeli Family Health Center, Bağcılar, Istanbul
- Ability to speak and understand Turkish
- Ability to read and write
- Having a child within the age range covered by the national vaccination schedule (0-13 years)
- Being 18 years of age or older
Key exclusion criteria (3 listed)
- Not attending one or more of the educational sessions
- Participating in any training other than the vaccination education program
- Failing to complete the data collection forms in full
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 |
|---|---|---|
| Vaccination attitudeThis study was planned to determine the effect of face-to-face and group education given to mothers regarding childhood vaccinations on their attitudes and decisions about vaccination. It is thought that the education provided will help eliminate mothers' misconceptions and false beliefs about vaccines in the short term and contribute to positive changes in their attitudes and decisions regarding vaccination. Moreover, it is anticipated that, in the long term, this intervention will contribute to achieving better immunization rates and protecting children from vaccine-preventable diseases. This study is also important in terms of emphasizing the midwife's role in protecting and improving infant and community health. | Behavioural | Group 1: Mothers receiving individual face-to-face education, Group 2: Mothers receiving group education |
Primary outcome
Vaccine Opposition Scale
Time frame: 6 month
The total score of the long form ranges from 21 to 105, while the total score of the short form ranges from 12 to 60. Higher scores on the scale indicate higher levels of vaccine hesitancy among participants."The long form of the scale demonstrated high internal consistency (Cronbach's alpha = 0.905)."
Vaccine Attitudes Scale
Time frame: 6 month
Each item on the Vaccine Attitudes Scale is scored as agree = 1, undecided = 2, and disagree = 3. The total score is calculated by summing the item scores. The possible total score ranges from 11 to 33, where a score of 11 indicates a positive parental attitude toward vaccination, and a score of 33 indicates a negative attitude toward vaccination. The scale does not have a cut-off point. As the total score increases, parental vaccine hesitancy increases, reflecting a more negative attitude toward vaccination. "The Turkish version of the scale demonstrated acceptable internal consistency (Cronbach's alpha = 0.66)."
Data Collection Form
Time frame: 6 month
This form was developed by the researcher and the advisor based on the relevant literature (Yorulmaz et al., 2024; Ünsal, 2020; Yiğit et al., 2020; Hazır, 2018) and consists of 27 questions. It will be used in the study to determine mothers' demographic and descriptive characteristics and their decisions regarding vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Childhood Immunization
RecruitingObservational study
A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Microvideos for Improving HPV Vaccination Among Childhood Cancer Survivors
HPV Vaccination
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Not yet recruiting
Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study
Anxiety, Vaccination Hesitancy
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.
Songül ÇOLAK principal investigator
Istanbul Provincial Directorate of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination attitude in people with Childhood Immunization, run by Istanbul University - Cerrahpasa 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 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?
This study is still under way. Results are not available in the source record yet.
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 Opposition Scale (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.