Vaccination RefusalNCT05390697
Educational Videos to Address Vaccine Hesitancy in Childhood Immunization
A study testing Educational videos in people with Vaccination Refusal and Vaccine Hesitancy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal, Vaccine Hesitancy
- What is being tested?
- Educational videos
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Jun 2021to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children had contraindicated for immunization
- Children were dropped out if they did not finish their studies.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vaccination Refusal, Vaccine Hesitancy
- Being tested
- Educational videos
- Keywords
- health education, health promotion, Indonesia, vaccination, vaccination hesitancy
- Medical subject headings
- Vaccination Refusal, Vaccination Hesitancy, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The educational videos included five modules distributed over five weeks. Receives: Other: Educational videos |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parent Attitudes about Childhood Vaccines (PACV) Questionnaire
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
Measured: Five weeks after intervention
Secondary outcomes (1)
Childhood routine immunization status
Childhood routine immunization status (complete/incomplete/improved)
Measured: Five weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start18 Jun 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Hartono Gunardi, MD, PhD, Universitas Indonesia
- Investigators
- Hartono Gunardi, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390697
- Sponsor's protocol ID
- 1042/UN2.F1/ETIK/PPM.00.02
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Videos to Address Vaccine Hesitancy in Childhood Immunization
- ClinicalTrials.gov ID
- NCT05390697
- Acronym / sponsor ID
- 1042/UN2.F1/ETIK/PPM.00.02
- Conditions
- Vaccination Refusal, Vaccine Hesitancy
- Keywords
- health education, health promotion, Indonesia, vaccination, vaccination hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Educational videosThe educational videos included five modules distributed over five weeks. |
| Control group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children had contraindicated for immunization
- Children were dropped out if they did not finish their studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videosEducational 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. | Other | Intervention group |
Primary outcome
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
1 secondary outcome
Childhood routine immunization status
Time frame: Five weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hartono Gunardi, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational videos in people with Vaccination Refusal and Vaccine Hesitancy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parent Attitudes about Childhood Vaccines (PACV) Questionnaire (time frame: Five weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.