Virtual Reality Intervention Procedure Simulator

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05029219

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Novice Doctor	Device: Arm I (Virtual reality group) Device: Arm II (Self study group)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 31, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Checklist score [60 min of education programs]
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.

Secondary Outcome Measures

Global rating score [60 min of education programs]
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.
Time taken to perform lumbar transforaminal epidural injection [Procedure duration]
During the pre-test and post-test, how long it takes to perform the procedure is compared.
Number of fluroscopy shots when performing lumbar transforaminal epidural injection under a fluoroscopy guide [Procedure duration]
It is determined by comparing the number of fluroscopy pictures
Participants' satisfaction with the curriculum [60 min of education programs]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Yeong Kim, Assistant Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05029219

Other Study ID Numbers:

3-2021-0237

First Posted:

Aug 31, 2021

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 12, 2022