Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS) (EIORS-CPS)

December 23, 2024 updated by: Walid Mohamed Ragab Mohamed Badwi, King Saud Medical City

Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety

Simulation-based training has emerged as a valuable tool for enhancing communication skills among healthcare professionals. This study aimed to evaluate the impact of operating room (OR) simulations on the development of communication skills for patient safety. The study focused on two key areas: the development of communication skills for patient-centered care and the role of the WHO Surgical Safety Checklist in enhancing communication and patient safety during simulations.

Study Overview

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

Observational

Enrollment (Estimated)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: jumana B BAAJ, consultant
  • Phone Number: 009664670011
  • Email: bjumana@gmail.com

Study Locations

      • Riyadh, Saudi Arabia, 11461
        • Recruiting
        • King Saud University , College of Medicine, Anesthesia Department
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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:
  • Patient Safety Simulation

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Communication Skills during Simulations
Time Frame: 7-8 months

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

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

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)

March 3, 2024

Primary Completion (Estimated)

January 25, 2025

Study Completion (Estimated)

February 25, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

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)?

NO

IPD Plan Description

At this time, there are no plans to share individual participant data (IPD) publicly. The study will retain data within the institution for research purposes only.

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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