NCT05029219

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

August 11, 2021

Last Update Submit

January 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Global rating score

    60 min of education programs

  • Time taken to perform lumbar transforaminal epidural injection

    Procedure duration

  • Number of fluroscopy shots when performing lumbar transforaminal epidural injection under a fluoroscopy guide

    Procedure duration

  • Participants' satisfaction with the curriculum

    60 min of education programs

Study Arms (2)

Virtual reality group

EXPERIMENTAL

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)

Self study group

ACTIVE COMPARATOR

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)

Interventions

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.

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 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.

Self study group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 31, 2021

Study Start

August 31, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations