Vaccine HesitancyNCT06680414
Impact of Supportive Vaccine Communication on Vaccine Desicion Processes
A study testing Supportive Vaccine Communication Using Motivational Interviewing in people with Vaccine Hesitancy, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of Supportive Vaccine Communication using Motivational Interviewing on the level of vaccination literacy, vaccine knowledge, and vaccine decision thought. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Supportive Vaccine Communication Using Motivational Interviewing
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 May 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be residing in Artvin city center
- To have applied to the gynecology and obstetrics clinic of a hospital in the city center for any reason.
- T o be in the first 28 weeks of pregnancy
- Being 18 years or older
- Turkish - speaking
- Volunteering to participate in research
Who cannot join
- 1. To reside outside of Artvin city center
- 2. To be 29 weeks or older in pregnancy
- 3. Being under 18 years old
- 4. Not know to speak Turkish
- 5. Not volunteering for research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Deniz S. Sümeyye YORULMAZ
Merkez, Artvin, 08000
About this study
Official title: The Effects of Supportive Vaccine Communication Using Motivational Interviewing on Vaccine Knowledge, Vaccine Literacy, and Vaccine Decision Processes of Pregnant Mothers: A Waiting-List Randomized Controlled Trial
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of Supportive Vaccine Communication using Motivational Interviewing on the level of vaccination literacy, vaccine knowledge, and vaccine decision thought. Research hypothesis "H0: Supportive Vaccine Communication using Motivational Interviewing does not affect vaccine decision processes (vaccine literacy, vaccine knowledge, and vaccine decision thought). At the end of the training, it is thought that the pregnant mothers in the experimental group will be different from the control group regarding vaccine literacy, vaccine knowledge, and vaccine decision-making thoughts included in the model.
Read the detailed description
In determining the sample size in the study, the smallest effect size value obtained for the Vaccine Literacy Scale result in a doctoral thesis based on another model on non-pregnant mothers in the same region was taken into consideration. In this thesis, the partial eta-squared value for Critical Vaccine Literacy was determined 0.260 (Yorulmaz, 2024). For this value, 95% power and 0.05% alpha type error margin and the total sample size required to estimate the interaction effects were determined as 48. Considering the sample losses, the sample was increased by 20% (9.6 people ~ 10 people), and a total of 58 people, 29 of which were experimental and 29 control, was determined. Pregnant mothers who apply to the obstetrics and gynecology clinic of the hospital's, which are research areas, will be evaluated according to the eligibility criteria. Then, a surveyor will obtain contact information from pregnant mothers, who met the inclusion criteria, volunteered for the study, and consented, and collect pre-test. In the study, pregnant mothers will be stratified as primiparous pregnant women (first pregnancy) and multiparous pregnant women (2 and more pregnancies). Participants will be divided into experimental and control groups using blind technique, stratification, and block randomization. The supportive vaccination communication using prepared on the motivational interview method for the pregnant mothers in the experimental group will be face-to-face training. The training will be in the form of 3-part and 6-sessions (with a 1-week interval) as group training for 3-5 people, and each session will last 40 minutes on average. After the Supportive Vaccine Communication process of the pregnant mothers in the experimental group is completed, the data collection forms will be applied again to the pregnant mothers in the experimental and control groups. After the last measurement, a 3-part, and 6-session supportive vaccine communication process will be applied to the pregnant mothers in the control group in the same way and within the same scope as the experimental group.
The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy, vaccine knowledge, and vaccine decision thought.
- Conditions
- Vaccine Hesitancy
- Being tested
- Supportive Vaccine Communication Using Motivational Interviewing
- Keywords
- Vaccines, pregnant woman, experimental model, randomized controlled trial
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Vaccine Communication Using Motivational InterviewingOther
Supportive Vaccine Communication using Motivational Interviewing will be administered to the pregnant mothers in the experimental group by the researcher. The training will take place in 3-part and 6-sessions, one week apart, and each session will last approximately 40 minutes. The training will be carried out as group training with 3-5 people. Data collection forms will be applied before and after the program.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Supportive Vaccine Communication using Motivational Interviewing will be administered to the pregnant mothers in the experimental group by the researcher. The training will take place in 3-part and 6-sessions, one week apart, and each session will last approximately 40 minutes. The training will be carried out as group training with 3-5 people. Data collection forms will be applied before and after the program. Receives: Other: Supportive Vaccine Communication Using Motivational Interviewing |
| control | No intervention | No intervention will be made to the pregnant mothers in the control group during the education process of the experimental group. After the training process of the pregnant mothers in the experimental group is completed and the post-test data are collected, all the interventions and training will be given to the pregnant mothers in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy.
Vaccine Literacy Scale: The scale evaluates the level of vaccine literacy. The Vaccine Literacy Scale was developed by Ahoran et al. (2017). The scale consists of 3 sub-dimensions and 13 items: Functional, Communicative, and Critical Health Literacy. The Functional Health Literacy subscale consists of 5 items, the Communicative Health Literacy subscale consists of 5 items, and the Critical Health Literacy subscale consists of 3 items (Ahoran et al., 2017). The Turkish evaluation of the scale was made by Yorulmaz and Kocoglu-Tanyer and, the Vaccine Literacy Scale for childhood vaccinations is a valid and reliable measurement tool for Turkish culture (Yorulmaz and Kocoglu-Tanyer, 2024).
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The primary outcome expected from the study is the change in pregnant mothers' vaccine knowledge.
Vaccine Knowledge Test: The test was developed by Yorulmaz and Kocoglu-Tanyer to assess adults' vaccine knowledge. In the Vaccine Knowledge Test, there are 28 questions answered as true, false, and do not know. Expert opinion was taken while creating the Vaccine Knowledge Test, and the content validity was evaluated. The lowest score that can be obtained from the Vaccine Knowledge Test is 0, and the highest score is 28; The increase in the total score indicates that the vaccination knowledge is high.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment. Block randomization will be used in the randomization process. Randomizer.org will be used to select block combinations with six blocks. Pregnant mothers will first be stratified according to their number of pregnancies. Eligible participants will be randomly assigned to the intervention or waitlist group using the permuted block randomization method on a 1:1 basis. The waiting list group will form the second set of the research, which is planned to be attempted two months later. The participant assignment list will be generated by a non-research statistician with a random distribution sequence. Assignment confidentiality will be ensured using opaque sealed envelopes containing sequence numbers. The data analyst/statistician will be blind to the participants' group assignments.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Sümeyye YORULMAZ, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680414
- Sponsor's protocol ID
- ArtvinCoruhUn
- Status last verified
- May 2025
- First submitted
- 5 Nov 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Supportive Vaccine Communication Using Motivational Interviewing on Vaccine Knowledge, Vaccine Literacy, and Vaccine Decision Processes of Pregnant Mothers: A Waiting-List Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06680414
- Acronym / sponsor ID
- ArtvinCoruhUn
- Conditions
- Vaccine Hesitancy
- Keywords
- Vaccines, pregnant woman, experimental model, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 8 Nov 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.
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of Supportive Vaccine Communication using Motivational Interviewing on the level of vaccination literacy, vaccine knowledge, and vaccine decision thought. Research hypothesis "H0: Supportive Vaccine Communication using Motivational Interviewing does not affect vaccine decision processes (vaccine literacy, vaccine knowledge, and vaccine decision thought). At the end of the training, it is thought that the pregnant mothers in the experimental group will be different from the control group regarding vaccine literacy, vaccine knowledge, and vaccine decision-making thoughts included in the model.
Detailed description
In determining the sample size in the study, the smallest effect size value obtained for the Vaccine Literacy Scale result in a doctoral thesis based on another model on non-pregnant mothers in the same region was taken into consideration. In this thesis, the partial eta-squared value for Critical Vaccine Literacy was determined 0.260 (Yorulmaz, 2024). For this value, 95% power and 0.05% alpha type error margin and the total sample size required to estimate the interaction effects were determined as 48. Considering the sample losses, the sample was increased by 20% (9.6 people ~ 10 people), and a total of 58 people, 29 of which were experimental and 29 control, was determined. Pregnant mothers who apply to the obstetrics and gynecology clinic of the hospital's, which are research areas, will be evaluated according to the eligibility criteria. Then, a surveyor will obtain contact information from pregnant mothers, who met the inclusion criteria, volunteered for the study, and consented, and collect pre-test. In the study, pregnant mothers will be stratified as primiparous pregnant women (first pregnancy) and multiparous pregnant women (2 and more pregnancies). Participants will be divided into experimental and control groups using blind technique, stratification, and block randomization. The supportive vaccination communication using prepared on the motivational interview method for the pregnant mothers in the experimental group will be face-to-face training. The training will be in the form of 3-part and 6-sessions (with a 1-week interval) as group training for 3-5 people, and each session will last 40 minutes on average. After the Supportive Vaccine Communication process of the pregnant mothers in the experimental group is completed, the data collection forms will be applied again to the pregnant mothers in the experimental and control groups. After the last measurement, a 3-part, and 6-session supportive vaccine communication process will be applied to the pregnant mothers in the control group in the same way and within the same scope as the experimental group.
The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy, vaccine knowledge, and vaccine decision thought.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Random assignment. Block randomization will be used in the randomization process. Randomizer.org will be used to select block combinations with six blocks. Pregnant mothers will first be stratified according to their number of pregnancies. Eligible participants will be randomly assigned to the intervention or waitlist group using the permuted block randomization method on a 1:1 basis. The waiting list group will form the second set of the research, which is planned to be attempted two months later. The participant assignment list will be generated by a non-research statistician with a random distribution sequence. Assignment confidentiality will be ensured using opaque sealed envelopes containing sequence numbers. The data analyst/statistician will be blind to the participants' group assignments.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Supportive Vaccine Communication Using Motivational InterviewingSupportive Vaccine Communication using Motivational Interviewing will be administered to the pregnant mothers in the experimental group by the researcher. The training will take place in 3-part and 6-sessions, one week apart, and each session will last approximately 40 minutes. The training will be carried out as group training with 3-5 people. Data collection forms will be applied before and after the program. |
| control | No intervention | –No intervention will be made to the pregnant mothers in the control group during the education process of the experimental group. After the training process of the pregnant mothers in the experimental group is completed and the post-test data are collected, all the interventions and training will be given to the pregnant mothers in the control group. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- To be residing in Artvin city center
- To have applied to the gynecology and obstetrics clinic of a hospital in the city center for any reason.
- T o be in the first 28 weeks of pregnancy
- Being 18 years or older
- Turkish - speaking
Key exclusion criteria (5 listed)
- 1. To reside outside of Artvin city center
- 2. To be 29 weeks or older in pregnancy
- 3. Being under 18 years old
- 4. Not know to speak Turkish
- 5. Not volunteering for research
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 |
|---|---|---|
| Supportive Vaccine Communication Using Motivational InterviewingSupportive Vaccine Communication using Motivational Interviewing will be administered to the pregnant mothers in the experimental group by the researcher. The training will take place in 3-part and 6-sessions, one week apart, and each session will last approximately 40 minutes. The training will be carried out as group training with 3-5 people. Data collection forms will be applied before and after the program. | Other | experimental |
Primary outcome
The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy.
Time frame: through study completion, an average of 1 year
Vaccine Literacy Scale: The scale evaluates the level of vaccine literacy. The Vaccine Literacy Scale was developed by Ahoran et al. (2017). The scale consists of 3 sub-dimensions and 13 items: Functional, Communicative, and Critical Health Literacy. The Functional Health Literacy subscale consists of 5 items, the Communicative Health Literacy subscale consists of 5 items, and the Critical Health Literacy subscale consists of 3 items (Ahoran et al., 2017). The Turkish evaluation of the scale was made by Yorulmaz and Kocoglu-Tanyer and, the Vaccine Literacy Scale for childhood vaccinations is a valid and reliable measurement tool for Turkish culture (Yorulmaz and Kocoglu-Tanyer, 2024).
1 secondary outcome
The primary outcome expected from the study is the change in pregnant mothers' vaccine knowledge.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Ahoran et al., 2017Link provided by the sponsor.
- Yorulmaz and Kocoglu-Tanyer, 2024Link provided by the sponsor.
- Bisset and Paterson, 2018Link provided by the sponsor.
- Damnjanovi´c et al., 2018Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Vaccine Communication Using Motivational Interviewing in people with Vaccine Hesitancy, run by Artvin Coruh 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 6 inclusion and 5 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 21 May 2025. 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?
The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy. (time frame: through study completion, an average of 1 year). 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 21 May 2025.