Virtual Reality Intervention Procedure Simulator

A Prospective Randomized Controlled Study for the Efficacy of Virtual Reality Intervention Procedure Simulator on the Training of Pain Procedures

The purpose of this study is to prove the effectiveness of the virtual reality program in educating lumbar transforaminal epidural blocks to novice doctors.

Study Overview

• Status: Completed
• Conditions: Novice Doctor
• Intervention / Treatment: Device: Arm I (Virtual reality group); Device: Arm II (Self study group)

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents in department of anesthesiology and pain medicine unfamiliar with fluoroscopy guided epidural block

Exclusion Criteria:

• Residents in department of anesthesiology and pain medicine familiar with fluoroscopy guided epidural block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality group; To become proficient in lumbar transforaminal epidural blocks, participants receive additional training using virtual reality programs after audiovisual education.	Device: Arm I (Virtual reality group); In the preparatory session, the participant is given a survey. It is about demographic information such as gender, age, and age, as well as prior experience with the procedure. The primary test is performed with a fluoroscopy guided lumbar transforaminal epidural block with a human-shaped phantom. After that, the test group and the control group receive the same audiovisual education for about 5 minutes. The test group receives about 60 minutes of training using a virtual reality program.
Active Comparator: Self study group; In order to become proficient in lumbar transforaminal epidural block, participants have self-study time using books and videos after audiovisual education.	Device: Arm II (Self study group); In the preparatory session, the participant is given a survey. It is about demographic information such as gender, age, and age, as well as prior experience with the procedure. The primary test is performed with a fluoroscopy guided lumbar transforaminal epidural block with a human-shaped phantom. After that, the test group and the control group receive the same audiovisual education for about 5 minutes. The control group have provided with video materials and books provided during audiovisual education and have given time for self-study for 60 minutes. Subsequently, a second test is performed with a fluroscopy-guided lumbar transforaminal epidural block with a human-shaped phantom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checklist score	When all training courses are completed and a post-test is performed on the phantom, it is determined how much the checklist score has changed compared to the screening time. Range from 0 to 7. Minimum score means worst and maximum score means good performance.	60 min of education programs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global rating score	When all training courses are completed and a post-test is performed on the phantom, it is determined how much the global rating score has changed compared to the screening time. Range from 7 to 35. Minimum score means worst and maximum score means good performance.	60 min of education programs
Time taken to perform lumbar transforaminal epidural injection	During the pre-test and post-test, how long it takes to perform the procedure is compared.	Procedure duration
Number of fluroscopy shots when performing lumbar transforaminal epidural injection under a fluoroscopy guide	It is determined by comparing the number of fluroscopy pictures	Procedure duration
Participants' satisfaction with the curriculum	After the completion of all training and testing sessions, have participants rate their satisfaction with the training on a 100-point scale. Range from 0 to 100. Minimum score means less satisfaction and maximum score means better satisfaction.	60 min of education programs

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 3-2021-0237

Drug and device information, study documents

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