Immunisation Simulation Using the Real-size Infant Manikin in Medical Education

May 19, 2022 updated by: Prof. Hartono Gunardi, MD, PhD, Indonesia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

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

  • Indonesia
      • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta
  • Medical students who attended immunisation workshops

Exclusion Criteria:

  • Students who refused to participate
  • Students who did not attend the immunisation workshops

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
70 minutes course using newly developed real-size infant's arm and leg manikin
Other: Newly developed real-size infant's arm and leg manikin
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.
No Intervention: Control group
70 minutes course using conventional manikin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Seven weeks after the immunization course
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
Seven weeks after the immunization course
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
Seven weeks after the immunization course
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
Seven weeks after the immunization course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Hartono Gunardi, MD, PhD, Indonesia University

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)

October 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 653/UN2.F1/ETIK/PPM.00.02

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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