Novice DoctorNCT05029219
Virtual Reality Intervention Procedure Simulator
A study testing Arm I (Virtual reality group) and Arm II (Self study group) in people with Novice Doctor, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Novice Doctor
- What is being tested?
- Arm I (Virtual reality group) and Arm II (Self study group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents in department of anesthesiology and pain medicine unfamiliar with fluoroscopy guided epidural block
Who cannot join
- Residents in department of anesthesiology and pain medicine familiar with fluoroscopy guided epidural block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Novice Doctor
- Being tested
- Arm I (Virtual reality group), Arm II (Self study group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | To become proficient in lumbar transforaminal epidural blocks, participants receive additional training using virtual reality programs after audiovisual education. Receives: 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. Receives: Device: Arm II (Self study group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 min of education programs
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 60 min of education programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start31 Aug 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novice DoctorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029219
- Sponsor's protocol ID
- 3-2021-0237
- Status last verified
- Jan 2022
- First submitted
- 11 Aug 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study for the Efficacy of Virtual Reality Intervention Procedure Simulator on the Training of Pain Procedures
- ClinicalTrials.gov ID
- NCT05029219
- Acronym / sponsor ID
- 3-2021-0237
- Conditions
- Novice Doctor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Device: Arm I (Virtual reality group)To become proficient in lumbar transforaminal epidural blocks, participants receive additional training using virtual reality programs after audiovisual education. |
| Self study group | Active comparator | Device: Arm II (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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residents in department of anesthesiology and pain medicine unfamiliar with fluoroscopy guided epidural block
Key exclusion criteria (1 listed)
- Residents in department of anesthesiology and pain medicine familiar with fluoroscopy guided epidural block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual reality group |
| 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. | Device | Self study group |
Primary outcome
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.
4 secondary outcomes
Global rating score
Time frame: 60 min of education programs
Time taken to perform lumbar transforaminal epidural injection
Time frame: Procedure duration
Number of fluroscopy shots when performing lumbar transforaminal epidural injection under a fluoroscopy guide
Time frame: Procedure duration
Participants' satisfaction with the curriculum
Time frame: 60 min of education programs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (Virtual reality group) and Arm II (Self study group) in people with Novice Doctor, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Checklist score (time frame: 60 min of education programs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.