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Vaccine HesitancyNCT05425823

Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes

A study testing Health Belief Model Based Intervention in people with Vaccine Hesitancy and Childhood Vaccination, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vaccine Hesitancy, Childhood Vaccination
What is being tested?
Health Belief Model Based Intervention
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Jul 2022to 19 Jan 2024
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necmettin Erbakan University

    Konya, Konya/MEram, 42130

Other trials in Turkey (Türkiye)

About this study

Official title: Randomized Controlled Trial Of A Health Belief Model-Based Intervention To Prompt To Take Up The Childhood Vaccines And Effect On Vaccination Attitudes

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.

Read the detailed description

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.

Being tested
Health Belief Model Based Intervention
Keywords
Vaccine hesitancy, childhood vaccination, health belief model, parental attitudes, 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.

  • Health Belief Model Based InterventionOther

    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.

Study groups in NCT05425823
Study groupRoleWhat they receive
Education and messageExperimentalIn 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.
Receives: Other: Health Belief Model Based Intervention
EducationExperimentalIn 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.
Receives: Other: Health Belief Model Based Intervention
Standard Care GroupNo interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1.month

  2. 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.

    Measured: 6th.month

  3. 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.

    Measured: 12.month

Secondary outcomes (3)
  1. Scores from the Public Attitude Towards Vaccination Scale - Health Belief Model

    The Public Attitude Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the intervention groups (1 and 2) were similar the standard care group's at the 1st months postpartum.

    Evaluation of the scale cannot be made over the total score. It consists of a total of 26 questions and 5 sub-dimensions. When all five sub-dimensions and sub-dimensions with a five-point Likert response are evaluated separately; Susceptibility and severity sub-dimension consists of 4 items (lowest 4, highest 20 points), benefit and health responsibility sub-dimension 5 items (lowest 5 points, highest 25 points), barrier sub-dimension consists of 8 items (lowest 8, highest 40 points). While a decrease in the score in the obstacle sub-dimension indicates a positive attitude, an increase in the score in the other sub-dimensions indicates a positive attitude.

    Measured: 1.month

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

    The Public Attitude Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the intervention groups (1 and 2) were similar the standard care group's at the 6th months postpartum.

    Evaluation of the scale cannot be made over the total score. It consists of a total of 26 questions and 5 sub-dimensions. When all five sub-dimensions and sub-dimensions with a five-point Likert response are evaluated separately; Susceptibility and severity sub-dimension consists of 4 items (lowest 4, highest 20 points), benefit and health responsibility sub-dimension 5 items (lowest 5 points, highest 25 points), barrier sub-dimension consists of 8 items (lowest 8, highest 40 points). While a decrease in the score in the obstacle sub-dimension indicates a positive attitude, an increase in the score in the other sub-dimensions indicates a positive attitude.

    Measured: 6.month

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

    The Public Attitude Towards Vaccination Scale-Health Belief Model sub-dimensions (severity, susceptibility, benefit, barrier, health motivation) scores of the intervention groups (1 and 2) were similar the standard care group's at the 12th months postpartum.

    Evaluation of the scale cannot be made over the total score. It consists of a total of 26 questions and 5 sub-dimensions. When all five sub-dimensions and sub-dimensions with a five-point Likert response are evaluated separately; Susceptibility and severity sub-dimension consists of 4 items (lowest 4, highest 20 points), benefit and health responsibility sub-dimension 5 items (lowest 5 points, highest 25 points), barrier sub-dimension consists of 8 items (lowest 8, highest 40 points). While a decrease in the score in the obstacle sub-dimension indicates a positive attitude, an increase in the score in the other sub-dimensions indicates a positive attitude.

    Measured: 12.month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start4 Jul 2022
  3. Primary completion30 Dec 2023
  4. Study completion19 Jan 2024

Resources

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
parallel randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425823
Sponsor's protocol ID
221430001
Status last verified
Feb 2024
First submitted
13 Jun 2022
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Health Belief Model Based Intervention in people with Vaccine Hesitancy and Childhood Vaccination, run by Necmettin Erbakan 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 4 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?

Children's vaccination rates 1st (time frame: 1.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 20 Feb 2024.

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