Clinical trial NCT06680414: Impact of Supportive Vaccine Communication on Vaccine Desicion Processes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Hesitancy
Keywords: Vaccines
pregnant woman
experimental model
randomized controlled trial
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 1. To reside outside of Artvin city center
* 2. To be 29 weeks or older in pregnancy
* 3. Being under 18 years old
* 4. Not know to speak Turkish
* 5. Not volunteering for research

Primary outcomes:
measure: The primary outcome expected from the study is the change in pregnant mothers' vaccine literacy.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The primary outcome expected from the study is the change in pregnant mothers' vaccine knowledge.
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: The primary outcome expected from the study is the change in pregnant mothers' vaccine decision thought.
timeFrame: through study completion, an average of 1 year
Locations:
city: Merkez
country: Turkey
facility: Deniz S. Sümeyye YORULMAZ
state: Artvin
Study officials:
References: