Operating RoomsEORMST-KSUNCT06748131
Efficiency of Operating Room Simulation for Training Medical Students at King Saud University (EORMST-KSU)
An observational study of Operating Rooms and High Fidelity Simulation Training, run by King Saud Medical City at 1 site in Saudi Arabia.
Trial summary
This study aims to evaluate the effectiveness of operating room (OR) simulation-based training in improving anesthesia skills and decision-making for medical students at King Saud University. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Operating Rooms, High Fidelity Simulation Training
- How many people
- 10,911 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Mar 2024to 3 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will involve fourth-year medical students from the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University, Riyadh, Saudi Arabia. These students will undergo simulation-based training designed to enhance their technical and decision-making skills in anesthesia. Students will be assessed for their proficiency and adaptability in anesthesia skills before and after participating in the simulation training sessions.
Who may be able to join
- Medical students enrolled in the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University.
- Students in their fourth year of medical school.
- Consent to participate in simulation-based training and data collection.
- Ability to understand and follow instructions in English.
Who cannot join
- Students who have previously undergone simulation-based anesthesia training.
- Students who are not in good academic standing.
- Students with documented medical conditions that could affect their ability to participate in simulation sessions (e.g., severe anxiety or motion sickness).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University Medical City (KSUMC), College of Medicine
Riyadh, 11461
About this study
Official title: Efficiency of Operating Room Simulation for Training Medical Students in the MEDI045 Program at King Saud University
This study aims to evaluate the effectiveness of operating room (OR) simulation-based training in improving anesthesia skills and decision-making for medical students at King Saud University. Specifically, the study focuses on the integration of SimMan 3G technology and high-fidelity simulation scenarios within the MEDI045 Basic Anesthesia and Resuscitation course.
By engaging in realistic, high-stress scenarios, the students will practice essential tasks such as airway management, anesthesia administration, and patient surveillance. The goal is to enhance students' technical skills, critical decision-making, and ability to adapt to dynamic clinical conditions.
Read more
In addition to evaluating improvements in anesthesia competencies, the study also seeks to assess student satisfaction and confidence levels after completing the simulation-based training. The research will contribute to a better understanding of how simulation can bridge the gap between theoretical knowledge and practical application in anesthesia education.
Data collected will include quantitative measures of technical proficiency and decision-making effectiveness, along with qualitative feedback regarding students' experiences, perceptions of competency, and overall satisfaction with the revised curriculum. The findings will help refine medical education practices, with a focus on patient safety, effective communication, and teamwork within the OR.
The study is being conducted at King Saud University and involves fourth-year medical students enrolled in the MEDI045 course.
Read the detailed description
This study aims to assess the impact of simulation-based training on the development of anesthesia skills and clinical decision-making in medical students enrolled in the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University. The primary intervention involves the integration of SimMan 3G high-fidelity simulators within the course curriculum, providing students with immersive, realistic scenarios that closely replicate the dynamic conditions of a real operating room (OR).
The key focus areas of the study include:
Technical Skills Development: The study will evaluate students' proficiency in performing essential anesthesia tasks, such as airway management, drug administration, and patient monitoring. Skills will be assessed through both pre- and post-simulation tests to measure improvements in technique and dexterity.
Decision-Making and Critical Thinking: By simulating high-pressure scenarios, the study aims to evaluate how well students make decisions under stress, particularly with respect to patient safety. Students' abilities to assess and respond to fluctuating clinical conditions will be analyzed, with a focus on minimizing errors and improving patient outcomes.
Student Adaptability: A key objective of the study is to measure students' adaptability in managing unforeseen complications. The simulations will expose students to a range of emergency situations, such as intraoperative crises, and evaluate their ability to maintain composure and provide effective care.
Student Satisfaction and Confidence: Post-simulation surveys and structured debriefing sessions will be used to gather qualitative data on student satisfaction and perceived confidence in their ability to manage anesthesia in real-world settings.
The study uses a mixed-methods research design, combining quantitative analysis (using pre- and post-test scores and statistical methods like t-tests and chi-square tests) with qualitative data (from surveys and debriefing sessions). The study will measure not only technical proficiency but also examine how simulation influences students' psychological readiness and communication skills within a team-based environment.
Data gathered will be used to evaluate the effectiveness of simulation-based training in improving both anesthesia skills and decision-making abilities. The results will inform future curriculum improvements, with the goal of enhancing patient safety, communication, and teamwork within medical education.
- Conditions
- Operating Rooms, High Fidelity Simulation Training
- Keywords
- Operating room simulations, High fidelity simulation, Medical student training, Anesthesia education, Clinical decision-making
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Technical Anesthesia Skills Following Simulation-Based Training
This outcome will assess the change in technical proficiency in anesthesia-related procedures following simulation-based training using high-fidelity SimMan 3G simulators. Key skills assessed will include airway management, anesthesia induction and monitoring, and postoperative care. The assessment will be conducted at baseline (pre-training) and post-training (immediately following the final simulation session), with follow-up assessments at 1 month and 3 months to evaluate skill retention. The measurement tool used will be a skills assessment rubric specific to each procedure, with scores reflecting proficiency in each skill.
Measured: Pre-training (baseline) Post-training (immediately following the final simulation session) Follow-up assessments at 1 month and 3 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Mar 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operating RoomsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,911 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Walid Mohamed Ragab Mohamed Badwi, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748131
- Sponsor's protocol ID
- KingSaudMC
- Other IDs
- 2024;Ref. No. 24/1145/IRB
- Acronym
- EORMST-KSU
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Operating Room Simulation for Training Medical Students in the MEDI045 Program at King Saud University
- ClinicalTrials.gov ID
- NCT06748131
- Acronym / sponsor ID
- EORMST-KSU / KingSaudMC
- Conditions
- Operating Rooms, High Fidelity Simulation Training
- Keywords
- Operating room simulations, High fidelity simulation, Medical student training, Anesthesia education, Clinical decision-making
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,911 participants (estimated)
- Lead sponsor
- King Saud Medical CityOther government
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 27 Dec 2024 (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 study aims to evaluate the effectiveness of operating room (OR) simulation-based training in improving anesthesia skills and decision-making for medical students at King Saud University. Specifically, the study focuses on the integration of SimMan 3G technology and high-fidelity simulation scenarios within the MEDI045 Basic Anesthesia and Resuscitation course.
By engaging in realistic, high-stress scenarios, the students will practice essential tasks such as airway management, anesthesia administration, and patient surveillance. The goal is to enhance students' technical skills, critical decision-making, and ability to adapt to dynamic clinical conditions.
In addition to evaluating improvements in anesthesia competencies, the study also seeks to assess student satisfaction and confidence levels after completing the simulation-based training. The research will contribute to a better understanding of how simulation can bridge the gap between theoretical knowledge and practical application in anesthesia education.
Data collected will include quantitative measures of technical proficiency and decision-making effectiveness, along with qualitative feedback regarding students' experiences, perceptions of competency, and overall satisfaction with the revised curriculum. The findings will help refine medical education practices, with a focus on patient safety, effective communication, and teamwork within the OR.
The study is being conducted at King Saud University and involves fourth-year medical students enrolled in the MEDI045 course.
Detailed description
This study aims to assess the impact of simulation-based training on the development of anesthesia skills and clinical decision-making in medical students enrolled in the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University. The primary intervention involves the integration of SimMan 3G high-fidelity simulators within the course curriculum, providing students with immersive, realistic scenarios that closely replicate the dynamic conditions of a real operating room (OR).
The key focus areas of the study include:
Technical Skills Development: The study will evaluate students' proficiency in performing essential anesthesia tasks, such as airway management, drug administration, and patient monitoring. Skills will be assessed through both pre- and post-simulation tests to measure improvements in technique and dexterity.
Decision-Making and Critical Thinking: By simulating high-pressure scenarios, the study aims to evaluate how well students make decisions under stress, particularly with respect to patient safety. Students' abilities to assess and respond to fluctuating clinical conditions will be analyzed, with a focus on minimizing errors and improving patient outcomes.
Student Adaptability: A key objective of the study is to measure students' adaptability in managing unforeseen complications. The simulations will expose students to a range of emergency situations, such as intraoperative crises, and evaluate their ability to maintain composure and provide effective care.
Student Satisfaction and Confidence: Post-simulation surveys and structured debriefing sessions will be used to gather qualitative data on student satisfaction and perceived confidence in their ability to manage anesthesia in real-world settings.
The study uses a mixed-methods research design, combining quantitative analysis (using pre- and post-test scores and statistical methods like t-tests and chi-square tests) with qualitative data (from surveys and debriefing sessions). The study will measure not only technical proficiency but also examine how simulation influences students' psychological readiness and communication skills within a team-based environment.
Data gathered will be used to evaluate the effectiveness of simulation-based training in improving both anesthesia skills and decision-making abilities. The results will inform future curriculum improvements, with the goal of enhancing patient safety, communication, and teamwork within medical education.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will involve fourth-year medical students from the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University, Riyadh, Saudi Arabia. These students will undergo simulation-based training designed to enhance their technical and decision-making skills in anesthesia. Students will be assessed for their proficiency and adaptability in anesthesia skills before and after participating in the simulation training sessions.
Key inclusion criteria (4 listed)
- Medical students enrolled in the MEDI045 Basic Anesthesia and Resuscitation course at King Saud University.
- Students in their fourth year of medical school.
- Consent to participate in simulation-based training and data collection.
- Ability to understand and follow instructions in English.
Key exclusion criteria (3 listed)
- Students who have previously undergone simulation-based anesthesia training.
- Students who are not in good academic standing.
- Students with documented medical conditions that could affect their ability to participate in simulation sessions (e.g., severe anxiety or motion sickness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Technical Anesthesia Skills Following Simulation-Based Training
Time frame: Pre-training (baseline) Post-training (immediately following the final simulation session) Follow-up assessments at 1 month and 3 months post-training
This outcome will assess the change in technical proficiency in anesthesia-related procedures following simulation-based training using high-fidelity SimMan 3G simulators. Key skills assessed will include airway management, anesthesia induction and monitoring, and postoperative care. The assessment will be conducted at baseline (pre-training) and post-training (immediately following the final simulation session), with follow-up assessments at 1 month and 3 months to evaluate skill retention. The measurement tool used will be a skills assessment rubric specific to each procedure, with scores reflecting proficiency in each skill.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Operating Rooms and High Fidelity Simulation Training, run by King Saud Medical City at 1 site in Saudi Arabia.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Technical Anesthesia Skills Following Simulation-Based Training (time frame: Pre-training (baseline) Post-training (immediately following the final simulation session) Follow-up assessments at 1 month and 3 months post-training). 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 27 Dec 2024.