Pelvic vs Virtual Reality Simulator

Comparative Study to Determine Proper Sequence of Simulation Training Pelvic Versus Virtual Reality Simulator

The aim of this study is to evaluate the proper sequence of Pelvic trainer and VR simulator training in order to improve gynecological laparoscopic skills and assess training levels.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Training
• Intervention / Treatment: Device: Virtual reality Simulator; Device: Pelvic trainer:

Detailed Description

In this study, the investigators will determine the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator in order to improve laparoscopic skills of residents with no or little previous laparoscopic experience.

• This study will compare the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator of two groups: Group A versus Group B.
• Group A will start training on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1). Then at a later time, they will be trained on VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2).
• Group B will start training on the VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2). Then at a later time, they will be trained on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience

Exclusion Criteria:

• Residents who have previous good laparoscopic experiences.
• Age below 26 or Above 29 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First Group; the participants will start training on the pelvic trainer and assessment will be via assessment via a checklist. Then at a later time, they will be trained on VR simulator (Sim Surgery) and assessment will be via Electronic auto assessment via the Simulator.	Device: Virtual reality Simulator; LapSim is a device designed by Surgical Science Device & software at Swedan; Other Names: LapSim; Device: Pelvic trainer: Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught
Active Comparator: Second Group; the participants will start training on VR simulator (Sim Surgery) and assessment will be via Electronic auto assessment via the Simulator. Then at a later time, they will be trained on the pelvic trainer and assessment will be via assessment via a checklist.	Device: Virtual reality Simulator; LapSim is a device designed by Surgical Science Device & software at Swedan; Other Names: LapSim; Device: Pelvic trainer: Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of time needed to accomplish the tests before and after pelvic trainer	assessment of time needed to accomplish the tests before and after pelvic trainer	6 months
assessment of time needed to accomplish the tests before and after victual reality simulator	assessment of time needed to accomplish the tests before and after victual reality simulator	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa M Abdalla, MD, Kasralainy teaching hospital

Publications and helpful links

Helpful Links

• Virtual reality simulation training can improve technical skills during laparoscopic salpingectomy for ectopic pregnancy
• Assessment of technical skills transfer from the bench training model to the human model
• Description and validation of the Pelv-Sim: a training model designed to improve gynecologic minimally invasive suturing skills

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Simulation training; Pelvic trainer; Virtual reality Simulator
• Other Study ID Numbers: Pelvic trainer vs VRS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No