Vaccine RefusalNCT05713526
The Effect of Telehealth Service About Childhood Vaccines on Vaccine Attitudes and Vaccination
A study testing Telehealth service in people with Vaccine Refusal and Vaccination, run by Gozde AKSUCU at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to test the effect of telehealth service provided to pregnant women about childhood vaccines on vaccine attitudes and vaccination. The main questions it aims to answer are: Does telehealth service provided to pregnant women about childhood vaccines decrease the mean scores of the… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Refusal, Vaccination
- What is being tested?
- Telehealth service
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 May 2023
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Having the ability to understand, speak, read and write Turkish.
- The willingness of the primary care clinic staff to be cooperated to work
- Owning and using a smartphone
- Being in the last trimester of pregnancy
- Giving birth to the baby at a birth weight (≥ 2000 g) that will not affect the routine vaccination schedule
Who cannot join
- Have a miscarriage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Primary Care Clinics
Istanbul, Beylikdüzü, 34520
About this study
Official title: The Effect of Telehealth Service Provided to Pregnant Women About Childhood Vaccines on Vaccine Attitudes and Vaccination
The goal of this clinical trial is to test the effect of telehealth service provided to pregnant women about childhood vaccines on vaccine attitudes and vaccination.
The main questions it aims to answer are:
Read more
- Does telehealth service provided to pregnant women about childhood vaccines decrease the mean scores of the vaccine attitudes scale?
- Does telehealth service provided to pregnant women about childhood vaccines increase the vaccination?
In the intervention group, researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment.
In the control group, there will be no information or intervention about childhood vaccines by the researchers, and standard procedure will be followed.
Researchers will compare the intervention and control groups to see if there is a difference between vaccination attitudes and vaccination rates.
Read the detailed description
Place and Time of Research; The research will be carried out at primary care clinics in Istanbul Beylikdüzü between August 2022 and March 2023.
Population and Sample of the Research; The research population will consist of individuals who were last trimester of pregnancy in primary care clinics in Istanbul Beylikdüzü. The study sample will consist of at least 156 individuals determined by power analysis. Individuals who met the inclusion criteria were randomly assigned to the experimental and control groups with a table of random numbers.
In this study, the scales will be applied as a pre-post test. It does not pose any problem that will endanger the physical and mental health of the participants. Data collection forms; introductory information form, vaccine attitudes scale, vaccine follow-up form, and follow-up chart. Data collection tools; vaccination information video, e-brochures, reminder messages, answering parent questions via instant message, smartphone.
Before starting the research, ethics committee approval was obtained from Istanbul University-Cerrahpaşa Social and Human Sciences Ethics Committee, and institutional permission was obtained from the Istanbul Provincial Health Directorate. Participants were included in the study voluntarily. Before starting the study, participants were called by phone and informed about the study, and verbal consent was obtained with the "Informed Voluntary Consent Form."
- Conditions
- Vaccine Refusal, Vaccination
- Being tested
- Telehealth service
- Keywords
- Telehealth, Vaccine hesitation, Vaccine attitudes, Vaccination, Childhood immunization
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth serviceBehavioural
Researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth group | Experimental | The group in which telehealth services for childhood vaccines will be implemented. Receives: Behavioral: Telehealth service |
| Control group | No intervention | The group in which telehealth services for childhood vaccines will not be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine attitudes (Vaccine Attitudes Scale)
The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.
Measured: Before the intervention
Vaccine attitudes (Vaccine Attitudes Scale)
The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.
Measured: After the 6th month's vaccinations
Vaccination
Vaccination status on the day of the appointment
Measured: When the birth occurs
Vaccination
Vaccination status on the day of the appointment
Measured: When the baby is at the end of the 1st month
Vaccination
Vaccination status on the day of the appointment
Measured: When the baby is at the end of the 2nd month
Vaccination
Vaccination status on the day of the appointment
Measured: When the baby is at the end of the 4th month
Vaccination
Vaccination status on the day of the appointment
Measured: When the baby is at the end of the 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Aug 2022
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine RefusalStudies 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
- Pretest-posttest with the control group.
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gozde AKSUCU
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Gozde AKSUCU, University of Beykent
- Investigators
- Gözde AKSUCU, MSc, Study chair, Beykent UniversitySeda ÇAĞLAR, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713526
- Sponsor's protocol ID
- 2021/295
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksucu G, Caglar S. Effects of telehealth during pregnancy on childhood vaccine attitudes and timeliness: A randomized controlled trial. Vaccine. 2025 Sep 17;63:127678. doi: 10.1016/j.vaccine.2025.127678. Epub 2025 Aug 28.
PubMed 40882266
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telehealth Service Provided to Pregnant Women About Childhood Vaccines on Vaccine Attitudes and Vaccination
- ClinicalTrials.gov ID
- NCT05713526
- Acronym / sponsor ID
- 2021/295
- Conditions
- Vaccine Refusal, Vaccination
- Keywords
- Telehealth, Vaccine hesitation, Vaccine attitudes, Vaccination, Childhood immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Gozde AKSUCUUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Feb 2023 (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 goal of this clinical trial is to test the effect of telehealth service provided to pregnant women about childhood vaccines on vaccine attitudes and vaccination.
The main questions it aims to answer are:
- Does telehealth service provided to pregnant women about childhood vaccines decrease the mean scores of the vaccine attitudes scale?
- Does telehealth service provided to pregnant women about childhood vaccines increase the vaccination?
In the intervention group, researchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment.
In the control group, there will be no information or intervention about childhood vaccines by the researchers, and standard procedure will be followed.
Researchers will compare the intervention and control groups to see if there is a difference between vaccination attitudes and vaccination rates.
Detailed description
Place and Time of Research; The research will be carried out at primary care clinics in Istanbul Beylikdüzü between August 2022 and March 2023.
Population and Sample of the Research; The research population will consist of individuals who were last trimester of pregnancy in primary care clinics in Istanbul Beylikdüzü. The study sample will consist of at least 156 individuals determined by power analysis. Individuals who met the inclusion criteria were randomly assigned to the experimental and control groups with a table of random numbers.
In this study, the scales will be applied as a pre-post test. It does not pose any problem that will endanger the physical and mental health of the participants. Data collection forms; introductory information form, vaccine attitudes scale, vaccine follow-up form, and follow-up chart. Data collection tools; vaccination information video, e-brochures, reminder messages, answering parent questions via instant message, smartphone.
Before starting the research, ethics committee approval was obtained from Istanbul University-Cerrahpaşa Social and Human Sciences Ethics Committee, and institutional permission was obtained from the Istanbul Provincial Health Directorate. Participants were included in the study voluntarily. Before starting the study, participants were called by phone and informed about the study, and verbal consent was obtained with the "Informed Voluntary Consent Form."
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pretest-posttest with the control group.
| Arm | Type | Receives |
|---|---|---|
| Telehealth group | Experimental | Behavioral: Telehealth serviceThe group in which telehealth services for childhood vaccines will be implemented. |
| Control group | No intervention | –The group in which telehealth services for childhood vaccines will not be implemented. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the study
- Having the ability to understand, speak, read and write Turkish.
- The willingness of the primary care clinic staff to be cooperated to work
- Owning and using a smartphone
- Being in the last trimester of pregnancy
Key exclusion criteria (1 listed)
- Have a miscarriage
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 |
|---|---|---|
| Telehealth serviceResearchers will send educational materials (video and e-brochures) about childhood vaccinations to the participants' mobile phones at regular intervals, answer their questions over the phone and send reminder messages before the vaccination appointment. | Behavioural | Telehealth group |
Primary outcome
Vaccine attitudes (Vaccine Attitudes Scale)
Time frame: Before the intervention
The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.
Vaccine attitudes (Vaccine Attitudes Scale)
Time frame: After the 6th month's vaccinations
The scale was developed by Wallece et al. in 2019. The Turkish validity and reliability study was carried out by Ceylan et al. in 2021. The scale consists of 11 items in a 3-point Likert type that measures parents' attitudes toward vaccines. The scale has five sub-dimensions consisting of "benefits of the vaccine", "past vaccination behavior", "efficacy and safety", "awareness of vaccine-preventable diseases" and "confidence". Each item is scored between 1 and 3 (agree=1, undecided=2, disagree=3). The total score on the scale ranges from 11 to 33. 11 points indicate that parents have a positive attitude toward the vaccine, while 33 points indicate a negative attitude. The scale does not have a breakpoint. As the score obtained from the scale increases, the parents' hesitance toward vaccination increases, and that is, they show a negative attitude towards vaccination. Cronbach's alpha coefficient was calculated by Ceylan (2021) as 0.66 to evaluate the scale's internal consistency.
Vaccination
Time frame: When the birth occurs
Vaccination status on the day of the appointment
Vaccination
Time frame: When the baby is at the end of the 1st month
Vaccination status on the day of the appointment
Vaccination
Time frame: When the baby is at the end of the 2nd month
Vaccination status on the day of the appointment
Vaccination
Time frame: When the baby is at the end of the 4th month
Vaccination status on the day of the appointment
Vaccination
Time frame: When the baby is at the end of the 6th month
Vaccination status on the day of the appointment
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 19 Jul 2023.
- Derived from this study: PubMed 40882266Aksucu G, Caglar S. Effects of telehealth during pregnancy on childhood vaccine attitudes and timeliness: A randomized controlled trial. Vaccine. 2025 Sep 17;63:127678. doi: 10.1016/j.vaccine.2025.127678. Epub 2025 Aug 28.
- 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.
Gözde AKSUCU, MSc study chair
Beykent University
Seda ÇAĞLAR, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth service in people with Vaccine Refusal and Vaccination, run by Gozde AKSUCU 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 1 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 19 Jul 2023. 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?
Vaccine attitudes (Vaccine Attitudes Scale) (time frame: Before the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713526, which also lists 1 linked publication.
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 19 Jul 2023.