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NCT05648513
The Motivational Interview Teqhnique in Pregnant Women Who Are Hesitant in Childhood Vaccines
NA trial testing Motivational Interwiev in Vaccine Refusal in 52 participants. Status unknown.
1 April 2023
Quick facts
| Lead sponsor | Balikesir University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 52 |
| Start date | 28 December 2022 |
| Primary completion | 1 April 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Motivational Interwiev
Conditions studied
- Vaccine Refusal — all drugs for Vaccine Refusal →
- Pregnancy Related — all drugs for Pregnancy Related →
- Motivation — all drugs for Motivation →
Sponsor
Balikesir University
Who can join
Adults 18 to 49, female only, with Vaccine Refusal or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05648513 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Balikesir University
- Last refreshed: 13 December 2022
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