Patient-Centered CareEIORS-CPSNCT06755203
Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS)
An observational study of Patient-Centered Care and Competency-Based Education, run by King Saud Medical City at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient-Centered Care, Competency-Based Education
- What is being tested?
- Operating Room Simulation Training
- How many people
- 109 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Mar 2024to 25 Feb 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
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University , College of Medicine, Anesthesia Department
Riyadh, 11461
Dr. Walid M Badwi, MD, +966 547 874 681, Wbadawi@ksu.edu.sa
About this study
Official title: 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.
Read the 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
- Conditions
- Patient-Centered Care, Competency-Based Education
- Being tested
- Operating Room Simulation Training
- Keywords
- Patient safety, WHO Surgical Safety Checklist, Team communication, Stress management, Protocol adherence, Risk assessment, Operating room simulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating Room Simulation TrainingOther
Also called Patient Safety Simulation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Operating Room Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving Patient Safety Training through Simulation
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.
Measured: 7-8 months
Secondary outcomes (1)
Improvement in Communication Skills during Simulations
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.
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start3 Mar 2024
- Primary completion25 Jan 2025 (estimated)
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-Centered CareStudies 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
- 109 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
- NCT06755203
- Sponsor's protocol ID
- King Saud Medical City
- Other IDs
- IRB Ref. No. 24/1145/IRB
- Acronym
- EIORS-CPS
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety
- ClinicalTrials.gov ID
- NCT06755203
- Acronym / sponsor ID
- EIORS-CPS / King Saud Medical City
- Conditions
- Patient-Centered Care, Competency-Based Education
- Keywords
- Patient safety, WHO Surgical Safety Checklist, Team communication, Stress management, Protocol adherence, Risk assessment, Operating room simulations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- King Saud Medical CityOther government
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 1 Jan 2025 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation Training Group | – | Other: Operating Room Simulation TrainingParticipants will engage in operating room simulations designed to improve communication skills, stress management, and adherence to the WHO Surgical Safety Checklist. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operating Room Simulation TrainingAlso: Patient Safety SimulationThe 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 | Simulation Training Group |
Primary outcome
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.
1 secondary outcome
Improvement in Communication Skills during Simulations
Time frame: 7-8 months
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 1 Jan 2025.
- Individual participant dataSharing planned: No. 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.
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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.
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 Patient-Centered Care and Competency-Based Education, 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 3 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: looking for participants now, as of the sponsor's last update on 1 Jan 2025. 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?
Contact Walid M Badwi, MD (00966547874681, waledbadawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving Patient Safety Training through Simulation (time frame: 7-8 months). 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 1 Jan 2025.