NCT05648513

Brief Summary

Vaccine hesitancy is defined by World Health Organization(WHO) "Vaccine Hesitancy Working Group" as a delay in acceptance or refusal of vaccines despite availability of vaccination services(MacDonald,2015). WHO listed "vaccine hesitancy" as one of the ten global health threats that require immediate solution in 2019(WHO, 2019). It was found out that the primary causes of vaccine hesitancy are the risk-benefit ratio concerns, including "concerns about the safety of vaccines" or "their potential side-effects", and secondary causes are the lack of information and awareness about vaccines and their importance and religious, cultural, social gender and socioeconomic perceptions of vaccination(Lark et al., 2018).It is estimated in social studies that the prevalence of vaccine hesitancy is about 25-70% in the top-ranking France, 15% in Switzerland and 19% in Canada(Ward et al.,2019; Shen and Dubey,2019). In the case of pregnant women, on the other hand, childhood vaccine hesitancy has been detected to vary between 6% and 12%(Mohd et al.,2017; Corben and Leask,2018). There is a critical increase in the number of unvaccinated children in Turkey(Turkish Medical Association, 2018).Based on the data from Ministry of Health, number of families that refused to get their children vaccinated rose from 183 in 2011 to 12000 in 2016, and to 23600 in 2017(Turkish Medical Association, 2018). Motivation is the probability of the individual to adopt, continue and adhere to the special strategies of change.MI is a directive and counselee-oriented approach, which is employed to help the patients explore and overcome the ambivalence/dilemma in adopting the behaviors that will enhance and improve their overall health. Studies conducted in recent years have found out that motivational interviewing technique is actually effective in parents' acceptance of childhood vaccines. The main purpose of the MI technique is to explore the ambivalences of the target individuals and attain behavioral change by helping them overcome such ambivalences. This method is particularly useful with parents that are hesitant or ambivalent to get their children vaccinated, or those that fail to get them vaccinated. In MI, which focuses on the parents' concerns, questions and curiosities about the vaccines, the behavioral change takes place depending on the personal values of each individual. MI is a special means of aid to help individuals understand their problems and encourage them to take action(Danchin et al.,2017). In order to enhance vaccination services, studies must be conducted on the issue of vaccine opposition and hesitancy of families, and underlying reasons must be revealed(Topçu et al.,2019; Akbaş,2020). Due to the fact that pregnancy and antenatal periods are the time spans when the first perspectives and beliefs about childhood vaccination are formed, these periods are particularly important for providing information pediatric vaccines. Determining the prevalence of vaccine opposition within the society, and monitoring it in upcoming years, as well as making programs on inspection and education, are assumed to be crucial in the struggle with vaccine hesitancy. This study is particularly important as it will help eradicate vaccine hesitancy through using Motivational Interviewing (MI) method and revealing the ambivalent emotions about vaccine hesitancy in pregnant women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

December 5, 2022

Last Update Submit

December 5, 2022

Conditions

Keywords

Motivational interviewing, vaccine,vaccine hesitancy

Outcome Measures

Primary Outcomes (2)

  • Administered childhood vaccine

    Inspection of the vaccine card 1st and 2nd postnatal months and

    6 months

  • Vaccine Hesitant Score

    implementation of Parent Attitudes About Childhood Vaccines Survey (PACV)

    6 months

Study Arms (2)

Motivational Interview

EXPERIMENTAL

Parent Attitudes About Childhood Vaccines Survey (PACV) will be implemented to the pregnant women consulting to Atatürk City Hospital. Subjects with vaccine hesitancy will be randomly distributed to groups, and in this way, experimental (n=26) and control (n=26) groups will be formed. Routine antenatal monitoring will be kept with the control group. With the experimental group, on the other hand, motivational interviewing method will be implemented for 4 sessions of about 45 minutes each. Interviews will be held at 4 separate weekends, 1 session for each. Interviews will be performed via online means or face to face. Personal Details Form It is the survey form that includes such socio-demographic aspects of the participants as their ages and educational backgrounds, and their opinions about vaccines.

Behavioral: Motivational Interwiev

Control Group

NO INTERVENTION

Control Group Experimental Group ( n=26 ) Routine antenatal monitoring will be kept with the control group. Routine antenatal monitoring Completion of motivational interviewing session Inspection of the vaccine card 1st and 2nd postnatal months and implementation of Parent Attitudes About Childhood Vaccines Survey (PACV) Personal Details Form It is the survey form that includes such socio-demographic aspects of the participants as their ages and educational backgrounds, and their opinions about vaccines.

Interventions

Parent Attitudes About Childhood Vaccines Survey (PACV) will be implemented to the patients consulting to Atatürk City Hospital. Subjects with vaccine hesitancy will be randomly distributed to groups, and in this way, experimental (n=26) and control (n=26) groups will be formed. Routine antenatal monitoring will be kept with the control group. With the experimental group, on the other hand, motivational interviewing method will be implemented for 4 sessions of about 45 minutes each. Interviews will be held at 4 separate weekends, 1 session for each. Interviews will be performed via online means or face to face.

Motivational Interview

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being pregnant for 28+ weeks,
  • Experiencing hesitancy about childhood vaccines,
  • Agreeing to participate in the study,
  • Being literate,
  • Having no communication disability,
  • Volunteering to participate in the study,

You may not qualify if:

  • Having high risk pregnancy
  • Having psychiatric diseases
  • Adolescent pregnancy
  • Not accepting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaccination RefusalVaccination Hesitancy

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Dr.

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

December 28, 2022

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations