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Completed

NCT Number: NCT05713526

The Effect of Telehealth Service 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:

* 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.

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Key information

Conditions

Vaccine Refusal Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Vaccination Refusal

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Clinics

Istanbul, Beylikdüzü, 34520, Turkey (Türkiye)

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Vaccination

    Time frame: When the birth occurs

    Vaccination status on the day of the appointment

  4. Vaccination

    Time frame: When the baby is at the end of the 1st month

    Vaccination status on the day of the appointment

  5. Vaccination

    Time frame: When the baby is at the end of the 2nd month

    Vaccination status on the day of the appointment

  6. Vaccination

    Time frame: When the baby is at the end of the 4th month

    Vaccination status on the day of the appointment

  7. Vaccination

    Time frame: When the baby is at the end of the 6th month

    Vaccination status on the day of the appointment

Sponsors and collaborators

Lead sponsor

Gozde AKSUCU

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

The Effect of Telehealth Service Provided to Pregnant Women About Childhood Vaccines on Vaccine Attitudes and Vaccination

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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