NCT06753266

Brief Summary

This study explores the evolving landscape of operating room (OR) simulation by identifying key trends, addressing potential biases, and providing actionable recommendations for improvement. Using data-driven analysis, the research uncovers patterns in skill development and decision-making, offering insights into the effectiveness of current OR simulation programs. The study also tackles biases in data collection, including selection and response bias, ensuring the reliability of findings.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 16, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Simulation-Based TrainingAnesthesia EducationPatient SafetyOperating Room Simulation

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive Bias in Clinical Decision-Making

    Evaluate the change in cognitive bias during simulated clinical scenarios using the Cognitive Bias Assessment Tool (CBAT). This tool assesses the presence of cognitive biases (e.g., confirmation bias, anchoring bias) in decision-making. The unit of measure will be the percentage of bias-free decisions or correct decisions made by participants, based on the CBAT scoring system. The assessment will occur immediately after simulation training (within 1 day) and again 6 months post-training to measure both immediate and long-term changes in cognitive bias.

    Immediately after simulation training (within 1 day) Over 6 months post-training

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of medical trainees enrolled in the MEDI 045 anesthesia program at King Saud Medical City. Participants will include individuals with varying levels of clinical experience who are eligible for simulation-based training. Participants will be randomly selected from a list of eligible trainees in the MEDI 045 program.

You may qualify if:

  • Participants enrolled in the MEDI 045 anesthesia program at King Saud Medical City.
  • Medical students or trainees with prior exposure to basic clinical simulation.
  • Aged 18 years or older.
  • Willingness to participate in simulation-based training sessions.
  • Ability to provide informed consent.

You may not qualify if:

  • Participants with prior advanced simulation training in anesthesia.
  • Individuals with documented cognitive impairments or learning disabilities that may interfere with the study tasks.
  • Refuse to participate in post-simulation assessments or follow-ups.
  • Lack of fluency in the language of instruction used in the simulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

King Saud University MedicalCity

Riyadh, Riydh, 11461-7805-41, Saudi Arabia

Location

King Saud University MedicalCity

Riyadh, 11461-7805-41, Saudi Arabia

Location

King Saud University , College of Medicine, Anesthesia Department

Riyadh, 11461, Saudi Arabia

Location

King Saud University Medical City (KSUMC), College of Medicine

Riyadh, 11461, Saudi Arabia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident in Anesthesia, Instructor in MEDI 045, King Saud University College of Medicine.

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 31, 2024

Study Start

November 15, 2024

Primary Completion

January 15, 2025

Study Completion

March 15, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Locations