NCT06495359

Brief Summary

Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Made works; It shows that healthcare professionals and physicians establishing trust and communicating effectively with vaccine recipients and parents is one of the most effective ways to eliminate vaccine hesitations. They stated that in order for childhood vaccines to be administered at a high rate, effective communication should first be established with parents. This project aimed to determine the effect of the immunization education program on parents' vaccine hesitancy. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program regarding immunization will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the immunization education program applied to parents whose children are hospitalized on vaccine hesitancy. Although studies on vaccine hesitancy in parents have increased in recent years, most of them consist of descriptive studies aimed at determining the level of vaccine hesitancy and affecting factors. No intervention studies on the effect of immunization education in parents on vaccine hesitancy have been found.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 1, 2024

Last Update Submit

July 9, 2024

Conditions

Keywords

ImmunizationParentsEducation

Outcome Measures

Primary Outcomes (1)

  • Parental Vaccination Hesitancy Scale mean score

    The effect of the applied education on the mean score of the Parental Vaccination Hesitancy Scale will be evaluated.

    up to 10 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Researchers will administer the immunization education program to parents.

Other: immunization education program

Control group

NO INTERVENTION

No intervention

Interventions

The content of the immunization education program for parents was created by researchers based on the literature. Expert opinions will be obtained from 7 people who are experts in the fields of child health and disease nursing and public health nursing for the training program. The training program consists of 30 minutes. The education program will be delivered to parents in the form of a 30-minute training session using the face-to-face education model. Interactive education methods that enable parents' participation will be used.

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having a child between the ages of 0-6,
  • admitted to the pediatric ward,
  • who have not previously received training on immunization
  • Parents who volunteered to participate in the study

You may not qualify if:

  • illiterate
  • parents with mental retardation, vision and hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asli Akdeniz Kudubeş

Bilecik, Turkey (Türkiye)

RECRUITING

Study Officials

  • AKDENİZ KUDUBEŞ

    BİLECİK ŞEYH EDEBALİ UNIVERSITY

    STUDY DIRECTOR

Central Study Contacts

AKDENİZ KUDUBEŞ, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A parallel group (experiment-control) randomized controlled design, which is one of the experimental methods
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 10, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

March 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations