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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
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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:
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.
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-CerrahpaÅŸa 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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth group | Experimental | The group in which telehealth services for childhood vaccines will be implemented. |
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| Control group | No Intervention | The group in which telehealth services for childhood vaccines will not be implemented. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth service | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | After the 6th month's vaccinations |
| Vaccination | Vaccination status on the day of the appointment | When the birth occurs |
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Inclusion Criteria:
Exclusion Criteria:
Since pregnancy is specific to women, the study will be conducted for women.
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| Name | Affiliation | Role |
|---|---|---|
| Gözde AKSUCU, MSc | Beykent University | Study Chair |
| Seda ÇAĞLAR, PhD | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Clinics | Istanbul | Beylikdüzü | 34520 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40882266 | Derived | 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. |
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| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Pretest-posttest with the control group.
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| Vaccination | Vaccination status on the day of the appointment | When the baby is at the end of the 1st month |
| Vaccination | Vaccination status on the day of the appointment | When the baby is at the end of the 2nd month |
| Vaccination | Vaccination status on the day of the appointment | When the baby is at the end of the 4th month |
| Vaccination | Vaccination status on the day of the appointment | When the baby is at the end of the 6th month |