NCT07324356

Brief 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. 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).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress44%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 15, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 23, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

Vaccine hesitancy, Vaccination attitude, Vaccine education

Outcome Measures

Primary Outcomes (3)

  • 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)."

    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)."

    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.

    6 month

Study Arms (3)

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.

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.

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.

Interventions

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.

Group 1: Mothers receiving individual face-to-face educationGroup 2: Mothers receiving group education

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumeli Aile Sağlığı Merkezi

Istanbul, Bağcılar, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Songül ÇOLAK

    Istanbul Provincial Directorate of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwifery

Study Record Dates

First Submitted

November 23, 2025

First Posted

January 7, 2026

Study Start

November 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations