Immunization SkillsNCT05389020
Immunisation Simulation Using the Real-size Infant Manikin in Medical Education
A study testing Newly developed real-size infant's arm and leg manikin in people with Immunization Skills, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunization Skills
- What is being tested?
- Newly developed real-size infant's arm and leg manikin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2020to 30 Apr 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
- Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta
- Medical students who attended immunisation workshops
Who cannot join
- Students who refused to participate
- Students who did not attend the immunisation workshops
Trial locations and contacts
1 site in 1 country.
About this study
This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the confidence in immunization after the simulation.
- Conditions
- Immunization Skills
- Being tested
- Newly developed real-size infant's arm and leg manikin
- Keywords
- Simulation, Manikin, Immunization, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly developed real-size infant's arm and leg manikinOther
The control group used conventional manikins made by Nasco; meanwhile, two newly designed real-size manikins were prepared for the intervention group: the right arm and right leg. Real-size manikins were developed based on the mean of anthropometric measurement of 50 Indonesian infants' arms and legs of healthy term neonates born in Dr Cipto Mangunkusumo Hospital. The manikins were made of Thermoplastic Polyurethane (TPU) filament using three-dimensional (3D) printing technology. The manufacturing process was carried out by the Medical Physics Department, Universitas Indonesia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 70 minutes course using newly developed real-size infant's arm and leg manikin Receives: Other: Newly developed real-size infant's arm and leg manikin |
| Control group | No intervention | 70 minutes course using conventional manikin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge pre- and post-test questionnaire
The improvement of students' knowledge by using the real-size infant's arm and leg manikins
Measured: Seven weeks after the immunization course
Practical skill score using rubric
The improvement of students' practical skill by using the real-size infant's arm and leg manikins
Measured: Seven weeks after the immunization course
Number of students who were confident by self assessment using Likert scale questionnaire
The confidence in doing the immunization practice after the workshop
Measured: Seven weeks after the immunization course
Students' feedback questionnaire
Students' response and feedback regarding the practice using the real-size infant's arm and leg manikins
Measured: Seven weeks after the immunization course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Oct 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization SkillsStudies 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
- 205 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, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389020
- Sponsor's protocol ID
- 653/UN2.F1/ETIK/PPM.00.02
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunisation Simulation Using the Real-size Infant Manikin in Medical Education
- ClinicalTrials.gov ID
- NCT05389020
- Acronym / sponsor ID
- 653/UN2.F1/ETIK/PPM.00.02
- Conditions
- Immunization Skills
- Keywords
- Simulation, Manikin, Immunization, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 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.
This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the confidence in immunization after the simulation.
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: Newly developed real-size infant's arm and leg manikin70 minutes course using newly developed real-size infant's arm and leg manikin |
| Control group | No intervention | –70 minutes course using conventional manikin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta
- Medical students who attended immunisation workshops
Key exclusion criteria (2 listed)
- Students who refused to participate
- Students who did not attend the immunisation workshops
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 |
|---|---|---|
| Newly developed real-size infant's arm and leg manikinThe control group used conventional manikins made by Nasco; meanwhile, two newly designed real-size manikins were prepared for the intervention group: the right arm and right leg. Real-size manikins were developed based on the mean of anthropometric measurement of 50 Indonesian infants' arms and legs of healthy term neonates born in Dr Cipto Mangunkusumo Hospital. The manikins were made of Thermoplastic Polyurethane (TPU) filament using three-dimensional (3D) printing technology. The manufacturing process was carried out by the Medical Physics Department, Universitas Indonesia. | Other | Intervention group |
Primary outcome
Knowledge pre- and post-test questionnaire
Time frame: Seven weeks after the immunization course
The improvement of students' knowledge by using the real-size infant's arm and leg manikins
Practical skill score using rubric
Time frame: Seven weeks after the immunization course
The improvement of students' practical skill by using the real-size infant's arm and leg manikins
Number of students who were confident by self assessment using Likert scale questionnaire
Time frame: Seven weeks after the immunization course
The confidence in doing the immunization practice after the workshop
Students' feedback questionnaire
Time frame: Seven weeks after the immunization course
Students' response and feedback regarding the practice using the real-size infant's arm and leg manikins
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 24 May 2022.
Related trials for Immunization Skills
Not yet recruiting
Web-based Health Education on Information, Motivation, Behavioral Skills Related to Human Papilloma Virus Vaccination
Web Based Intervention
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
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 Newly developed real-size infant's arm and leg manikin in people with Immunization Skills, 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 2 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 24 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?
Knowledge pre- and post-test questionnaire (time frame: Seven weeks after the immunization course). The study lists 4 primary outcomes in all. 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 24 May 2022.