Impact of Supportive Vaccine Communication on Vaccine Desicion Processes

NCT06680414 | Completed DMC

• 1 other identifier: ArtvinCoruhUn
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccine Hesitancy

Keywords

Vaccines; pregnant woman; experimental model; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy.

  Vaccine Literacy Scale: The scale evaluates the level of vaccine literacy. The Vaccine Literacy Scale was developed by Ahoran et al. (2017). The scale consists of 3 sub-dimensions and 13 items: Functional, Communicative, and Critical Health Literacy. The Functional Health Literacy subscale consists of 5 items, the Communicative Health Literacy subscale consists of 5 items, and the Critical Health Literacy subscale consists of 3 items (Ahoran et al., 2017). The Turkish evaluation of the scale was made by Yorulmaz and Kocoglu-Tanyer and, the Vaccine Literacy Scale for childhood vaccinations is a valid and reliable measurement tool for Turkish culture (Yorulmaz and Kocoglu-Tanyer, 2024).

  through study completion, an average of 1 year

Secondary Outcomes (1)

• The primary outcome expected from the study is the change in pregnant mothers' vaccine knowledge.

  through study completion, an average of 1 year

Other Outcomes (1)

• The primary outcome expected from the study is the change in pregnant mothers' vaccine decision thought.

  through study completion, an average of 1 year

Study Arms (2)

experimental

EXPERIMENTAL

Supportive 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.

Other: Supportive Vaccine Communication Using Motivational Interviewing

control

NO INTERVENTION

No intervention will be made to the pregnant mothers in the control group during the education process of the experimental group. After the training process of the pregnant mothers in the experimental group is completed and the post-test data are collected, all the interventions and training will be given to the pregnant mothers in the control group.

Interventions

Supportive Vaccine Communication Using Motivational Interviewing OTHER

Supportive 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.

experimental

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be residing in Artvin city center
• To have applied to the gynecology and obstetrics clinic of a hospital in the city center for any reason.
• T o be in the first 28 weeks of pregnancy
• Being 18 years or older
• Turkish - speaking
• Volunteering to participate in research

You may not qualify if:

• \. To reside outside of Artvin city center
• \. To be 29 weeks or older in pregnancy
• \. Being under 18 years old
• \. Not know to speak Turkish
• \. Not volunteering for research

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Deniz S. Sümeyye YORULMAZ

Merkez, Artvin, 08000, Turkey (Türkiye)

Location

Related Links

• Ahoran et al., 2017
• Yorulmaz and Kocoglu-Tanyer, 2024
• Bisset and Paterson, 2018
• Damnjanovi´c et al., 2018

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding(Participant blinding) will be done; participants will not be told they are in the experimental or control group. A surveyor will invite pregnant mothers to the study, which will continue until the targeted sample number (58 participants) is reached. During the participant registration, the names and contact information of the mothers will be obtained; it will be stated that they will be contacted for the training process, that the training time may be extended, and that they will be given definite training. The participant registration is completed, the supportive vaccine communication process will begin. The second researcher(D-KT) in the research team will explain to the first researcher(DS-Y) that the participants are in the experimental or control group. The pregnant mothers in the control group will be assigned to the waiting list.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: Random assignment. Block randomization will be used in the randomization process. Randomizer.org will be used to select block combinations with six blocks. Pregnant mothers will first be stratified according to their number of pregnancies. Eligible participants will be randomly assigned to the intervention or waitlist group using the permuted block randomization method on a 1:1 basis. The waiting list group will form the second set of the research, which is planned to be attempted two months later. The participant assignment list will be generated by a non-research statistician with a random distribution sequence. Assignment confidentiality will be ensured using opaque sealed envelopes containing sequence numbers. The data analyst/statistician will be blind to the participants' group assignments.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)