Clinical Trials Directory

Trials / Completed

CompletedNCT06680414

Impact of Supportive Vaccine Communication on Vaccine Desicion Processes

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Artvin Coruh University · Academic / Other
Sex
Female
Age
18 Years – 49 Years
Healthy volunteers
Accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERSupportive 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.

Timeline

Start date
2025-01-01
Primary completion
2025-05-01
Completion
2025-05-01
First posted
2024-11-08
Last updated
2025-05-21

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06680414. Inclusion in this directory is not an endorsement.