Vaccine HesitationNCT06530875
Vaccination Hesitation in Expectant Mothers
A study testing training on hesitations regarding childhood vaccinations in people with Vaccine Hesitation, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitation
- What is being tested?
- training on hesitations regarding childhood vaccinations
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Nov 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy over 18 years of age
- Literacy
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training on Childhood Vaccines Given to Expectant Mothers on Vaccine Hesitation and Vaccine Literacy: A Randomised Controlled Experimental Study
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.
- Conditions
- Vaccine Hesitation
- Being tested
- training on hesitations regarding childhood vaccinations
- Keywords
- Vaccine Hesitancy, Vaccine Literacy, Immunization, Child, Pediatric Nursing
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training on hesitations regarding childhood vaccinationsBehavioural
Training will be given to expectant mothers on childhood vaccination hesitations
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental | The experimental group will be trained on hesitations in childhood vaccines. Receives: Behavioral: training on hesitations regarding childhood vaccinations |
| Control | No intervention | there will be no interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was planned as a cross section (pre-test post-test, experimental and control group) randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Nur MUHAFİZ, Yuzuncu Yil University
- Investigators
- Yuzuncu Y University, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530875
- Sponsor's protocol ID
- Yüksek Lisans Tez
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Childhood Vaccines Given to Expectant Mothers on Vaccine Hesitation and Vaccine Literacy: A Randomised Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT06530875
- Acronym / sponsor ID
- Yüksek Lisans Tez
- Conditions
- Vaccine Hesitation
- Keywords
- Vaccine Hesitancy, Vaccine Literacy, Immunization, Child, Pediatric Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research was planned as a cross section (pre-test post-test, experimental and control group) randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Behavioral: training on hesitations regarding childhood vaccinationsThe experimental group will be trained on hesitations in childhood vaccines. |
| Control | No intervention | –there will be no interference |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnancy over 18 years of age
- Literacy
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Adolescent pregnancy (under 18 years of age)
- Communication problems
- Having any psychiatric problem
- Having a chronic disease
- illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training on hesitations regarding childhood vaccinationsTraining will be given to expectant mothers on childhood vaccination hesitations | Behavioural | Arms |
Primary outcome
Vaccine Literacy Scale for Childhood Vaccines
Time frame: 3 weeks
The Vaccine Literacy Scale consists of 3 sub-dimensions and 13 items in total: Functional Health Literacy, Communicative Health Literacy and Critical Health Literacy.
1 secondary outcome
Vaccine Hesitation Scale
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuzuncu Y University study director
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training on hesitations regarding childhood vaccinations in people with Vaccine Hesitation, run by Yuzuncu Yil 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 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?
Results are not available in the source record.
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?
Vaccine Literacy Scale for Childhood Vaccines (time frame: 3 weeks). 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 31 Jul 2024.