Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes

NCT05425823 | Completed

• 1 other identifier: 221430001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of pregnant women aged 18 years and older who have completed their 28th week of pregnancy and received intervention based on the Health Belief Model, on encouraging childhood vaccinations and influencing their vaccination attitudes, compared to pregnant women who receive standard care group. The 12-month vaccination rate of newborns and the change in their attitudes will be determined according to the Public Attitude Towards Vaccination Scale - Health Belief Model.

Conditions

Vaccine Hesitancy; Childhood Vaccination

Keywords

Vaccine hesitancy; childhood vaccination; health belief model; parental attitudes; education

Outcome Measures

Primary Outcomes (3)

• Children's vaccination rates 1st

  Childhood vaccination rates of intervention groups and standard care group in the study were similar at the end of the 1st month.

  1.month

• Children's vaccination rates 6th

  Childhood vaccination rates of intervention groups and standard care group in the study were similar at the end of the 6th month.

  6th.month

• Children's vaccination rates 12th

  Childhood vaccination rates of intervention groups and standard care group in the study were similar at the end of the 12th months.

  12.month

Secondary Outcomes (3)

• Scores from the Public Attitude Towards Vaccination Scale - Health Belief Model

  1.month

• Scores from the Public Attitude Towards Vaccination Scale - Health Belief Model

  6.month

• Scores from the Public Attitude Towards Vaccination Scale - Health Belief Model

  12.month

Study Arms (3)

Education and message

EXPERIMENTAL

In Intervention Group 1, a face-to-face training session based on the Health Belief Model will be given once a week and SMS-based short messages will be sent to the spouse. Vaccination rates of children in the intervention group-1 in the study at the end of the 1st, 6th and 12th months will be evaluated. Public Attitudes Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the intervention group-1 at the 1st, 6th, and 12th months after birth will be evaluated.

Other: Health Belief Model Based Intervention

Education

EXPERIMENTAL

In Intervention Group 2, face-to-face training will be provided one day a week based on the Health Belief Model. Vaccination rates of children in the intervention group-2 in the study at the end of the 1st, 6th and 12th months will be evaluated. Public Attitudes Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the intervention group-2 at the 1st, 6th, and 12th months after birth will be evaluated.

Other: Health Belief Model Based Intervention

Standard Care Group

NO INTERVENTION

Standard information about childhood vaccines will be provided to the Standard Care Group at the Family Health Care Center. Vaccination rates of children in the Standard Care Group in the study at the end of the 1st, 6th and 12th months will be evaluated. Public Attitudes Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the Standard Care Group at the 1st, 6th, and 12th months after birth will be evaluated.

Interventions

Health Belief Model Based Intervention OTHER

In intervention group-1, Information Form and PAVS-HBM will be applied as a pre-test to pregnant women who have completed their 28th gestational week. Childhood Vaccination Training Based on the Health Belief Model will be given in the prenatal period by organizing 2 face-to-face and individual sessions for the researcher's pregnant women. Each session will take approximately 30-45 minutes, with each session being in a different week. In addition, at the end of each session, HBM-based short messages will be sent to the pregnant woman's husband and recorded with the Short Message Tracking Form. Intervention group-2 will receive the same training, but no text messages will be sent.

Education; Education and message

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy, completing the 28th week of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The pregnant woman and her spouse are Turkish literate,
• Completing the 28th week of pregnancy,
• Desire to participate in the study,
• The pregnant's spouse has any type of mobile phone.

You may not qualify if:

• The pregnant woman has any mental problem that causes learning difficulties or has been diagnosed (if detected in the pregnancy outpatient clinic record).
• weeks of pregnancy and above
• Living outside of the 3 central districts of Konya (Selçuklu, Meram, Karatay)

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Konya/MEram, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Filiz S Hisar

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: parallel randomized controlled trial

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: July 4, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 19, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)