- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05390697
Educational Videos to Address Vaccine Hesitancy in Childhood Immunization
May 19, 2022 updated by: Prof. Hartono Gunardi, MD, PhD, Indonesia University
Vaccine hesitancy and the COVID-19 pandemic may threaten immunization coverage in children.
This study aimed to evaluate the tailored educational videos to reduce vaccine hesitancy and analyze immunization completeness status.
The investigators conducted an interventional quasi-experimental study in three subdistricts of North Jakarta, Indonesia.
Participants were allocated into the intervention and control groups, and the Parent Attitudes about Childhood Vaccines (PACV) questionnaire was used to assess vaccine hesitancy status before and after the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jakarta Pusat, Indonesia, 10430
- Dr. Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents with children aged 10-18 months
- Parents who had electronic devices that could play videos, such as smartphones or tablets
- Registered in the community health centers database.
Exclusion Criteria:
- Children had contraindicated for immunization
- Children were dropped out if they did not finish their studies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The educational videos included five modules distributed over five weeks.
|
Educational videos include (1) danger and prevention of VPD; (2) rationales of completing immunization; (3) immunization amid the COVID-19 pandemic; (4) vaccine misconception; and (5) adverse events following immunization and how to treat it.
Each video was less than 2 minutes with clear and straightforward messages according to the National Institute of Health guideline for health education.
Materials were distributed through WhatsApp and viewed for five weeks.
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No Intervention: Control group
Participants in the control group were given exposure to the digital version of the MCH handbook, 2020 edition, consisting of animated pictures and simple instructions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Parent Attitudes about Childhood Vaccines (PACV) Questionnaire
Time Frame: Five weeks after intervention
|
Improvement in vaccine hesitancy among Indonesian parents who underwent educational videos intervention, compared to the maternal and child health (MCH) handbook digital version as a standard educational tool
|
Five weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childhood routine immunization status
Time Frame: Five weeks after intervention
|
Childhood routine immunization status (complete/incomplete/improved)
|
Five weeks after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hartono Gunardi, MD, PhD, Fakultas Kedokteran Universitas Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2021
Primary Completion (Actual)
December 10, 2021
Study Completion (Actual)
December 10, 2021
Study Registration Dates
First Submitted
May 16, 2022
First Submitted That Met QC Criteria
May 19, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1042/UN2.F1/ETIK/PPM.00.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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