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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389020
Recruitment Status : Completed
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Hartono Gunardi, MD, PhD, Indonesia University

Brief 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 confidence in immunization after the simulation.

Condition or disease Intervention/treatment Phase
Immunization Skills Other: Newly developed real-size infant's arm and leg manikin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immunisation Simulation Using the Real-size Infant Manikin in Medical Education
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389020


Locations
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Indonesia
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Hartono Gunardi, MD, PhD Indonesia University
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Responsible Party: Prof. Hartono Gunardi, MD, PhD, Prof, Indonesia University
ClinicalTrials.gov Identifier: NCT05389020    
Other Study ID Numbers: 653/UN2.F1/ETIK/PPM.00.02
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Hartono Gunardi, MD, PhD, Indonesia University:
Simulation
Manikin
Immunization
Vaccination