Clinical trial NCT05713526: The Effect of Telehealth Service About Childhood Vaccines on Vaccine Attitudes and Vaccination
Official title: The Effect of Telehealth Service Provided to Pregnant Women About Childhood Vaccines on Vaccine Attitudes and Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Refusal
Vaccination
Keywords: Telehealth
Vaccine hesitation
Vaccine attitudes
Vaccination
Childhood immunization
Lead sponsor: University of Beykent
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2023-02-06
Enrollment: 183
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest-posttest with the control group.
Primary purpose: OTHER

Brief 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 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."

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Have a miscarriage

Primary outcomes:
measure: Vaccine attitudes (Vaccine Attitudes Scale)
timeFrame: Before the intervention
measure: Vaccine attitudes (Vaccine Attitudes Scale)
timeFrame: After the 6th month's vaccinations
measure: Vaccination
timeFrame: When the birth occurs
measure: Vaccination
timeFrame: When the baby is at the end of the 1st month
measure: Vaccination
timeFrame: When the baby is at the end of the 2nd month
measure: Vaccination
timeFrame: When the baby is at the end of the 4th month
measure: Vaccination
timeFrame: When the baby is at the end of the 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Primary Care Clinics
state: Beylikdüzü
Study officials:
affiliation: Beykent University
name: Gözde AKSUCU, MSc
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Seda ÇAĞLAR, PhD
role: PRINCIPAL_INVESTIGATOR
References: