- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755203
Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS) (EIORS-CPS)
Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will provide valuable insights into student preferences for logbook formats in anesthesiology education, specifically within the MEDI 045 course. By comparing Excel sheet logbooks with traditional paper logbooks, it aims to elucidate how different documentation methods impact student engagement, satisfaction, and learning outcomes.
Understanding these preferences is crucial, as logbooks are not merely administrative tools but integral components of the educational experience that promote reflection, accountability, and skill development in clinical practice.
The findings will contribute to existing knowledge by identifying specific advantages and disadvantages of each format, highlighting the aspects that enhance or hinder student learning. Moreover, the research will inform curriculum designers and educators about effective strategies for logbook implementation, ultimately leading to improved educational tools that better align with students' needs
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Walid M Badwi, MD
- Phone Number: 00966547874681
- Email: waledbadawy@yahoo.com
Study Contact Backup
- Name: jumana B BAAJ, consultant
- Phone Number: 009664670011
- Email: bjumana@gmail.com
Study Locations
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Riyadh, Saudi Arabia, 11461
- Recruiting
- King Saud University , College of Medicine, Anesthesia Department
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Contact:
- Dr. Walid M Badwi, MD
- Phone Number: +966 547 874 681
- Email: Wbadawi@ksu.edu.sa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population includes medical students enrolled in the MEDI 045 course at King Saud University. These students are actively engaged in clinical education and exposed to scenarios requiring the development of communication skills and adherence to the WHO Surgical Safety Checklist.
Key Characteristics:
Academic Level: Medical students introduced to clinical practices in anesthesia.
Training Context: Students participating in structured educational activities, such as logbook maintenance and simulation-based learning.
Sample Size: Approximately 109 students to ensure robust analysis of communication skills and logbook preferences.
Description
Inclusion Criteria:
Participants must be medical students enrolled in the MEDI 045 course at King Saud University.
Must have prior exposure to basic patient safety and communication skills training.
Age: 18-25 years. Students must voluntarily consent to participate in the study and complete the required simulations and assessments.
Exclusion Criteria:
Students who have already completed formal simulation-based training on communication or patient safety outside the MEDI 045 curriculum.
Students are unable to participate in simulation sessions due to scheduling conflicts or medical reasons.
Participants were unwilling to provide informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Simulation Training Group
Participants will engage in operating room simulations designed to improve communication skills, stress management, and adherence to the WHO Surgical Safety Checklist.
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The intervention involves high-fidelity OR simulations focusing on critical areas of patient safety, including: Communication Skills: Emphasizing clear communication during surgical procedures. Stress Management: Training participants to manage stress effectively in high-pressure situations. Protocol Adherence: Practicing adherence to the WHO Surgical Safety Checklist. Risk Assessment: Identifying and mitigating potential safety risks in simulated scenarios
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improving Patient Safety Training through Simulation
Time Frame: 7-8 months
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Evaluate the effectiveness of simulation-based training in promoting patient safety with a focus on: Authenticity: Scenarios mirroring real operating room environments. Stress Management & Communication: Improving interpersonal dynamics, team synergy, and decision-making under pressure. Protocol Compliance & Risk Evaluation: Ensuring adherence to patient safety best practices. WHO Surgical Safety Checklist: Enhancing communication and protocol adherence. Evaluation Tool: Patient Safety Simulation Assessment Scale (PSSAS). Scale Range: 0-10 Criteria: 0-3: Minimal improvement. 4-6: Moderate improvement. 7-8: Significant improvement. 9-10: Excellent improvement. Higher scores indicate better outcomes. |
7-8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Communication Skills during Simulations
Time Frame: 7-8 months
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Evaluate the enhancement of communicative competencies, placing particular emphasis on: Clarity of Communication: The proficiency in transmitting information with efficacy. Teamwork: The synergy and coordination exhibited within the group. Adherence to Structured Communication Protocols: The implementation of standardized tools such as SBAR (Situation-Background-Assessment-Recommendation). Measurement Tool: A bespoke Structured Communication Skills Evaluation Checklist (SCSEC) will be employed. Scale Range: 0-10 Scoring Criteria: 0-3: Insignificant clarity and teamwork, accompanied by inadequate adherence to protocols. 4-6: Moderate clarity and teamwork, coupled with partial compliance to protocols. 7-8: Robust clarity and teamwork, characterized by commendable adherence to protocols. 9-10: Exemplary clarity and teamwork, demonstrating complete adherence to protocols. Elevated scores signify superior outcomes. |
7-8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- King Saud Medical City
- IRB Ref. No. 24/1145/IRB (Other Identifier: College of Medicine, KSU, Riyadh, Saudi Arabia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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