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Enrolling by invitationNCT06530875Updated Jul 31, 2024

Vaccination Hesitation in Expectant Mothers

An interventional study of training on hesitations regarding childhood vaccinations in Vaccine Hesitation, sponsored by Yuzuncu Yıl University. Enrolling by invitation at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The aim of this study is to increase the awareness of vaccination with the training on childhood vaccine hesitancy given to expectant mothers by a nurse during pregnancy. In addition, it is aimed to evaluate the effect of the training given to expectant mothers on vaccine hesitancy and vaccine literacy.

Hypotheses of the study

H0: Training on Childhood Vaccine Hesitancy does not affect vaccine hesitancy and vaccine literacy in expectant mothers.

H1a: Education on Childhood Vaccine Hesitancy affects vaccine hesitancy in expectant mothers.

H1b: Education on Childhood Vaccine Hesitancy affects vaccine literacy in expectant mothers.

Read the detailed description

Vaccination, which is one of the basic elements of preventive health services, is the most effective, safe and cost-effective health practice in protecting human health and preventing infectious diseases. Vaccination has been recognized as the most effective method for people to cope with infectious diseases. Vaccines protect infants and children against many diseases. Every year, 1 million 700 thousand people die in the world due to vaccine-preventable diseases (Odabaş \& Kuzlu Ayyıldız, 2021).

Despite scientific and historical evidence of the safety and effectiveness of vaccines and immunization, some groups are still hesitant and reluctant to accept vaccines and immunization. The concept of vaccine hesitancy was defined by the World Health Organization Strategic Advisory Group of Experts on Immunization (SAGE) Vaccine Hesitancy Working Group: "vaccine hesitancy is recognized as the delay or refusal to accept vaccines despite the availability of immunization services". These behaviors include refusal, delay or reluctant acceptance despite active concerns (Etesaminia \& Derinpınar, 2021). In our country, since 2010, negative media news about vaccines started to affect families and "vaccine refusal" started to be observed. As of 2015, the rates of vaccine refusal started to increase with the winning of the lawsuit on "obtaining parental consent for vaccine administration". While 183 families refused vaccination in 2011, 980 families in 2013, 5,400 families in 2015, 12,000 families in 2016 and 23,000 families in 2018 refused to vaccinate their children. It is stated that if the number of families refusing vaccines reaches 50 thousand, childhood infectious diseases that have been reduced or eradicated may cause an epidemic (Çıtak \& Aksoy, 2020). In this context, scientific studies should be conducted on the effects and side effects of vaccines, and effective communication and trust between parents and health personnel will be one of the most effective ways to eliminate hesitations about vaccination. In addition, the use of mass media and social media in informing and raising public awareness about the results of scientific studies on vaccines and their effects will enable rapid progress in the fight against "anti-vaccination". It is suggested that health personnel should be informed and raised awareness about the subject in order to make parents more aware of vaccine administration, appropriate vaccine counseling services should be provided for families against those who make anti-vaccine discourses, and educational programs can be prepared to increase the level of knowledge of parents about vaccines. (Argın et al., 2022).

Vaccine literacy encompasses the knowledge, motivation and competence to access, understand, evaluate and apply health information in order to make the right health decisions in daily life. Individuals with adequate vaccine literacy accept vaccination as a sine qua non of a functioning health system, undertake the task of vaccine advocacy in every environment they are in, and develop an uncomplicated system to ensure vaccine communication with other people (Şahin \& Baran Aksakal, 2022).

In a study, most of the participants stated that they obtained information about vaccines from the internet. Mothers emphasized that they frequently used social media for vaccines and other health issues, and that they were concerned about the information accessed and doubted about vaccines (Çıklar \& Döner, 2020). In a study examining the relationship between parents' e-health literacy and confidence in vaccines, it was found that parents' confidence in vaccines decreased as the e-health literacy level increased (Ceylan et al., 2022), while in another study examining the relationship between parents' health literacy and their attitudes and behaviors towards childhood vaccines, it was found that parents' health literacy level was not related to their attitudes and behaviors towards childhood vaccines (Ertuğrul \& Albayrak, 2021). In another study conducted with university students, it was found that as the health literacy level of university students increased, their anti-vaccine attitudes decreased (Ertaş \& Göde, 2021).

In a study, it was stated that the rate of vaccine refusal has reached serious dimensions, that this rate will increase further if measures are not taken, and that the most important of these measures is education. Therefore, it was reported that it is important to organize trainings on vaccines, especially in family health centers that provide primary health care services, and that active use of the media by health personnel on vaccination and vaccination is also required. at the same time, it was suggested that these trainings can also be done by meeting face to face with parents. as a result, it was reported that parents will be made aware of vaccination and a decrease in the rate of vaccine refusal will be observed (Huseynov, 2021).

The aim of this study is to increase the awareness of vaccination with the training on childhood vaccine hesitancy given to expectant mothers by a nurse during pregnancy. In addition, it is aimed to evaluate the effect of the training given to expectant mothers on vaccine hesitancy and vaccine literacy.

02

Conditions studied

  • Vaccine Hesitation

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Keywords

  • Vaccine Hesitancy
  • Vaccine Literacy
  • Immunization
  • Child
  • Pediatric Nursing
03

In context

Vaccination Hesitancy

121 studies on the registry are indexed under Vaccination Hesitancy; 14 are open to participants now.

This study's planned enrollment of 80 is below the median of 516 across 98 interventional studies indexed under Vaccination Hesitancy.

Browse Vaccination Hesitancy studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnancy over 18 years of age
  • Literacy
  • Volunteering to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Adolescent pregnancy (under 18 years of age)
  • Communication problems
  • Having any psychiatric problem
  • Having a chronic disease
  • illiteracy
  • Not volunteering to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Arms

    The experimental group will be trained on hesitations in childhood vaccines.

    Behavioral: training on hesitations regarding childhood vaccinations

  • No intervention
    Control

    there will be no interference

Interventions

  • Behavioraltraining on hesitations regarding childhood vaccinations

    Training will be given to expectant mothers on childhood vaccination hesitations

06

What researchers measure

Primary outcomes

  1. Vaccine Literacy Scale for Childhood Vaccines

    The Vaccine Literacy Scale consists of 3 sub-dimensions and 13 items in total: Functional Health Literacy, Communicative Health Literacy and Critical Health Literacy.

    Time frame: 3 weeks

Secondary outcomes

  1. Vaccine Hesitation Scale

    The vaccine hesitancy scale consists of 10 items. Items 1, 2, 3, 4, 6, 7 and 8 contain positive statements, while items 5, 9 and 10 contain negative statements. While the level of vaccine hesitancy decreases as the degrees given by the participants to the positive statements increase, the level of vaccine hesitancy increases as the degrees given to the negative statements increase.

    Time frame: 3 weeks

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Oct 2024, 3 months after the start.

Of 82 non-industry interventional studies with no phase under Vaccination Hesitancy, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 3 months is below that.

Counting every sponsor, half of 83 studies reached it within 5 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2024
First posted
Jul 31, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Oct 1, 2024
CompletionEst.
Nov 30, 2024
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06530875
Responsible party
Eda Nur MUHAFİZ (NURSE, Yuzuncu Yıl University) — Principal investigator
First posted
Jul 31, 2024
Start date
Jul 1, 2024
Primary completion
Oct 1, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

Yuzuncu Y University
study director · Yuzuncu Yıl University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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