Nurse's RoleNCT06495359
Effect of Immunization Education Program on Parental Vaccine Hesitation
A study testing immunization education program in people with Nurse's Role, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nurse's Role
- What is being tested?
- immunization education program
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having a child between the ages of 0-6,
- admitted to the pediatric ward,
- who have not previously received training on immunization
- Parents who volunteered to participate in the study
Who cannot join
- illiterate
- parents with mental retardation, vision and hearing impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Asli Akdeniz Kudubeş
Bilecik
ASLI AKDENİZ KUDUBEŞ, PHD, 5432715190, asli.akdeniz@bilecik.edu.tr
About this study
Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Made works; It shows that healthcare professionals and physicians establishing trust and communicating effectively with vaccine recipients and parents is one of the most effective ways to eliminate vaccine hesitations. They stated that in order for childhood vaccines to be administered at a high rate, effective communication should first be established with parents. This project aimed to determine the effect of the immunization education program on parents' vaccine hesitancy. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program regarding immunization will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the immunization education program applied to parents whose children are hospitalized on vaccine hesitancy. Although studies on vaccine hesitancy in parents have increased in recent years, most of them consist of descriptive studies aimed at determining the level of vaccine hesitancy and affecting factors. No intervention studies on the effect of immunization education in parents on vaccine hesitancy have been found.
Read the detailed description
The aim of the research will be carried out using a parallel group (experiment-control) randomized controlled design, which is one of the experimental methods, to determine the effect of the immunization education program on parents' vaccine hesitancy.
Goals:
- To examine the effect of the immunization education program on parents' vaccine hesitancy,
- To compare the average scores of the vaccine hesitancy scale between the parents in the experimental group and the control group in the project.
- Conditions
- Nurse's Role
- Being tested
- immunization education program
- Keywords
- Immunization, Parents, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunization education programOther
The content of the immunization education program for parents was created by researchers based on the literature. Expert opinions will be obtained from 7 people who are experts in the fields of child health and disease nursing and public health nursing for the training program. The training program consists of 30 minutes. The education program will be delivered to parents in the form of a 30-minute training session using the face-to-face education model. Interactive education methods that enable parents' participation will be used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Researchers will administer the immunization education program to parents. Receives: Other: immunization education program |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Vaccination Hesitancy Scale mean score
The effect of the applied education on the mean score of the Parental Vaccination Hesitancy Scale will be evaluated.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group (experiment-control) randomized controlled design, which is one of the experimental methods
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Aslı Akdeniz Kudubeş, Bilecik Seyh Edebali Universitesi
- Investigators
- AKDENİZ KUDUBEŞ, Study director, BİLECİK ŞEYH EDEBALİ UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495359
- Sponsor's protocol ID
- aslıkudubes
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immunization Education Program on Parental Vaccine Hesitation
- ClinicalTrials.gov ID
- NCT06495359
- Acronym / sponsor ID
- aslıkudubes
- Conditions
- Nurse's Role
- Keywords
- Immunization, Parents, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 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.
Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Made works; It shows that healthcare professionals and physicians establishing trust and communicating effectively with vaccine recipients and parents is one of the most effective ways to eliminate vaccine hesitations. They stated that in order for childhood vaccines to be administered at a high rate, effective communication should first be established with parents. This project aimed to determine the effect of the immunization education program on parents' vaccine hesitancy. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program regarding immunization will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the immunization education program applied to parents whose children are hospitalized on vaccine hesitancy. Although studies on vaccine hesitancy in parents have increased in recent years, most of them consist of descriptive studies aimed at determining the level of vaccine hesitancy and affecting factors. No intervention studies on the effect of immunization education in parents on vaccine hesitancy have been found.
Detailed description
The aim of the research will be carried out using a parallel group (experiment-control) randomized controlled design, which is one of the experimental methods, to determine the effect of the immunization education program on parents' vaccine hesitancy.
Goals:
- To examine the effect of the immunization education program on parents' vaccine hesitancy,
- To compare the average scores of the vaccine hesitancy scale between the parents in the experimental group and the control group in the project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A parallel group (experiment-control) randomized controlled design, which is one of the experimental methods
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: immunization education programResearchers will administer the immunization education program to parents. |
| Control group | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having a child between the ages of 0-6,
- admitted to the pediatric ward,
- who have not previously received training on immunization
- Parents who volunteered to participate in the study
Key exclusion criteria (2 listed)
- illiterate
- parents with mental retardation, vision and hearing impairment
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 |
|---|---|---|
| immunization education programThe content of the immunization education program for parents was created by researchers based on the literature. Expert opinions will be obtained from 7 people who are experts in the fields of child health and disease nursing and public health nursing for the training program. The training program consists of 30 minutes. The education program will be delivered to parents in the form of a 30-minute training session using the face-to-face education model. Interactive education methods that enable parents' participation will be used. | Other | Experimental group |
Primary outcome
Parental Vaccination Hesitancy Scale mean score
Time frame: up to 10 months
The effect of the applied education on the mean score of the Parental Vaccination Hesitancy Scale will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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.
AKDENİZ KUDUBEŞ study director
BİLECİK ŞEYH EDEBALİ 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 immunization education program in people with Nurse's Role, run by Bilecik Seyh Edebali Universitesi 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 2 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 10 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?
Contact AKDENİZ KUDUBEŞ, PHD (5432715190, asli.akdeniz@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Vaccination Hesitancy Scale mean score (time frame: up to 10 months). 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 10 Jul 2024.