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CompletedNCT03258073SimForLifeUpdated Apr 20, 2021

Does Simulation Scenario Execution Improve Acute Care Skills and Confidence Related to Maternal and Pediatric Care Emergencies?

An interventional study of Medical simulation using scenario execution in Maternal, Pediatric Care Emergencies, sponsored by Mbarara University of Science and Technology. Completed at 1 site in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.

Read the detailed description

In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training and intermittent opportunity to maintain skills in managing delivery complications and acute newborn and pediatric conditions. Interventions like effective resuscitation assistance at the time of birth are lifesaving. Every 30 second delay in establishing effective resuscitation at birth increases the risk of death by 16%. The purpose of this study is to test whether medical simulation can improve acute care skills and confidence related to maternal and pediatric care emergencies.

A solid body of evidence now supports simulation-based learning as superior to didactic teaching and problem-based learning for the acquisition of critical assessment and management skills, particularly for clinical emergencies. Simulation-based training promotes skill acquisition and retention, enhances teamwork, and increases knowledge and understanding of key procedures. Simulation-based learning is now the norm in medical, nursing and paramedical training in most high income settings. There remains a critical need to operationalize simulation-based learning in resource-constrained settings

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Conditions studied

  • Maternal, Pediatric Care Emergencies

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Keywords

  • maternal
  • newborn
  • resuscitation
  • emergencies
  • medical simulation
03

In context

Lead sponsor

Mbarara University of Science and Technology is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants are medical and nursing students in active clinical rotation; third and fifth year medical students and third and fourth year nursing students at Mbarara University of Science and Technology.

Exclusion criteria

Exclusion Criteria:

  • Exclude medical and nursing students in the pre-clinical years and those in non-clinical rotations at the time of the intervention.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Medical simulation using scenarion execution

    Study participants will be exposed to medical simulation using scenario execution. In this exercise, participants will be exposed to a scenario that simulates a medical emergency. They will be required to respond. Following their response, the participants will have a chance to share with the investigators their experiences and what they have learnt from the exposure in a debriefing session. The investigator will then provide feedback on their performance.

    Other: Medical simulation using scenario execution

Interventions

  • OtherMedical simulation using scenario execution

    Each team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency.

    Also known as: medical simulation methodology

06

What researchers measure

Primary outcomes

  1. Skills using the Scenario-execution-group test score

    This is a scenario specific score obtained from a multiple choice question (MCQ) test following execution of the scenario to measure. The MCQs are standard questions developed to accompany a given scenario. The maximum score is 100%. A scenario-execution-group test score of less than 60% will be a fail and a score of more than or equal to 60% will be a pass.

    Time frame: Immediately Post scenario execution

Secondary outcomes

  1. Knowledge

    Knowledge will be measured using multiple choice questions (MCQs) and Investigators will use the Retrospective pre-post survey (RPP survey) to assess performance confidence among participants. In the RPP, the participant is asked to compare their performance after the intervention with that before the intervention. This assessment removes the bias of over or underestimating how much the participant knew before the intervention.

    Time frame: Change in knowledge scores at 4 months from Baseline

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Study locations

1 site
  • Mbarara University of Science and Technology
    Mbarara, 256, Uganda
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References and documents

Individual participant data

Plan to share: Undecided — Data to be shared when necessary permissions have been obtained

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Aug 2019, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2017
First posted
Aug 23, 2017
StartActual
Aug 30, 2017
Primary completionActual
Aug 30, 2019
CompletionActual
Dec 31, 2020
Last update
Apr 20, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03258073
Lead sponsor
Mbarara University of Science and Technology
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Aug 30, 2017
Primary completion
Aug 30, 2019
Completion
Dec 31, 2020
Last update
Apr 20, 2021

Study contacts

Santorini Data, MD
principal investigator · Mbarara University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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