Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes
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ClinicalTrials.gov Identifier: NCT05425823 |
Recruitment Status :
Completed
First Posted : June 21, 2022
Last Update Posted : February 20, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 13, 2022 | ||||||
First Posted Date ICMJE | June 21, 2022 | ||||||
Last Update Posted Date | February 20, 2024 | ||||||
Actual Study Start Date ICMJE | July 4, 2022 | ||||||
Actual Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Intervention to Promote Childhood Vaccinations and Influence Vaccination Attitudes | ||||||
Official Title ICMJE | Randomized Controlled Trial Of A Health Belief Model-Based Intervention To Prompt To Take Up The Childhood Vaccines And Effect On Vaccination Attitudes | ||||||
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. | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: parallel randomized controlled trial Masking: Single (Outcomes Assessor)Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Other: 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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
54 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | January 19, 2024 | ||||||
Actual Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Turkey | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05425823 | ||||||
Other Study ID Numbers ICMJE | 221430001 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kübra Sultan Dengiz, Necmettin Erbakan University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Necmettin Erbakan University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Necmettin Erbakan University | ||||||
Verification Date | February 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |