Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes

NCT ID: NCT05425823

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Today, vaccines are still recognized as one of the most important public health services, and millions of lives are saved each year. Despite the success of vaccination, such as eradicating certain diseases in the community and preventing epidemics, it is the fact that approximately 20 million infants/children have insufficient access to vaccines every year. The main reasons for this are vaccine hesitancy or vaccine rejection. Deaths from measles decreased by 73% worldwide between 2000 and 2018, preventing an estimated 23.2 million deaths. According to the Extended Immunization Program in our country, 13 routine vaccines in total are provided free of charge by primary health care services. According to the results of the Turkey Demographic and Health Surveys, the minimum vaccinations required for 12-23 month old children to be deemed to have received all age-appropriate vaccines are as follows; one dose of tuberculosis vaccine, three doses of pertussis-tetanus-polio-hemophilus influenza type b vaccine, three doses of hepatitis b vaccine, three doses of pneumococcal conjugate vaccine, one dose of oral polio vaccine. Considering both the vaccination card of the children (59%) and the personal statements (8%) of the mothers in our society, it was determined that only 67% of the children aged 12-23 months received all age-appropriate vaccinations. In addition, 2% of 12-23-month-old children have never been vaccinated. In addition, 50% of 24-35 months old children have all their age-appropriate vaccinations, while 3% have never been vaccinated. Looking at all these rates, it is seen that some babies/children are not vaccinated for various reasons, even in our country alone. To increase vaccination rates, preventive interventions should be developed to identify the causes of vaccine hesitations and reduce these hesitations. What needs to be done first to eliminate vaccine hesitations should be to increase the perceived sensitivity of individuals to the vaccine and decrease their expectations for negative results. At the same time, it is necessary to know the factors that cause negative attitudes about vaccination and to make them positive so that attitudes can turn into behaviors. According to the Health Belief Model, which is one of the models related to the development and maintenance of health behaviors, the probability of a person taking action to prevent the disease depends on the perceived susceptibility, perceived severity, perceived benefit, and perceived barrier factors, and indirectly includes the probability of exhibiting preventive health behavior. Among the factors affecting the vaccination decision of pregnant women, vaccine risk perceptions are effective; It has been determined that pregnant women who have general knowledge about the vaccine, those who know that there is a national vaccination policy, and those who believe that the vaccine is beneficial for their babies are more likely to be vaccinated. For this reason, it is recommended that the advice of healthcare professionals should be personalized. In line with all these data, the aim of the study is to examine the effectiveness of the intervention of training to be given to pregnant women about childhood vaccinations and sending messages to their spouses within the framework of the Health Belief Model; to evaluate the effect on childhood vaccination rates and vaccination attitudes in the postpartum period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaccine Hesitancy Childhood Vaccination

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education and message

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.

Group Type EXPERIMENTAL

Health Belief Model Based Intervention

Intervention Type 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

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.

Group Type EXPERIMENTAL

Health Belief Model Based Intervention

Intervention Type 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.

Standard Care Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Health Belief Model Based Intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kübra Sultan Dengiz

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Filiz S Hisar

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Necmettin Erbakan University

Konya, Konya/MEram, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

221430001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ARISe at UMass Chan
NCT07236034 RECRUITING NA
Measles Vaccine in HCW
NCT04357028 SUSPENDED PHASE3