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OpenTrials
Completed

NCT Number: NCT05029219

Virtual Reality Intervention Procedure Simulator

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

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm I (Virtual reality group)

Device

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.

Arm II (Self study group)

Device

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.

Primary outcomes

  1. Checklist score

    Time frame: 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 outcomes

  1. Global rating score

    Time frame: 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.

  2. Time taken to perform lumbar transforaminal epidural injection

    Time frame: Procedure duration

    During the pre-test and post-test, how long it takes to perform the procedure is compared.

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

    Time frame: Procedure duration

    It is determined by comparing the number of fluroscopy pictures

  4. Participants' satisfaction with the curriculum

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2021
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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