Neuraxial UltrasonographyNCT05874609
Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine
A study testing Teaching with VR spine simulator and Traditional didactic teaching in people with Neuraxial Ultrasonography, run by Peking Union Medical College Hospital.
Trial summary
As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire. Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neuraxial Ultrasonography
- What is being tested?
- Teaching with VR spine simulator and Traditional didactic teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 30 Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- anesthesia residents in our department
Who cannot join
- having previous experience of spine ultrasonography training
- having previous experience of spine ultrasound scan.
About this study
Official title: Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine: a Randomized Controlled Trial
As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire. Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education. The aim of our study is to evaluate the practical skills of ultrasound scan and the satisfaction of students who undergo training using VR versus traditional didactic lecture.
Read the detailed description
This is a prospective, single-center, randomized control trial to evaluate the performance of spine ultrasound scan after different training methods. Participants were randomly divided into two groups receiving different training methods: VR spine simulator or traditional didactic teaching. After the training, participants were required to perform a preprocedural spine ultrasound scan on healthy volunteers using the stepwise technique taught in the didactic teaching session. The participants needed to acquire three key ultrasound views during the scan and recognize the anatomic structures in three ultrasound views.
- Conditions
- Neuraxial Ultrasonography
- Being tested
- Teaching with VR spine simulator, Traditional didactic teaching
- Keywords
- ultrasound-guided, neuraxial anesthesia, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching with VR spine simulatorOther
The participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session. The learning objective with the VR simulator is to review the 3D lumbar spine anatomic model，learn the sonoanatomy presented by a dynamic ultrasound scan of the sagittal and transverse plane, and practice a preprocedural ultrasound scan.
Traditional didactic teachingOther
A 30-min traditional didactic teaching session of spine ultrasonography. This session was consisted of general spine anatomy, sonographic technique and sonoanatomy, description of five key spine ultrasonographic views (transverse spinous process view, transverse interlaminar view, parasagittal oblique interlaminar view, parasagittal articular process view, parasagittal transverse process view), and a stepwise technique of preprocedural lumbar spine scan
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | In the VR group, the participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session. Receives: Other: Teaching with VR spine simulator |
| Control group | Active comparator | In the control group, the participants received a 30-min traditional didactic teaching session of spine ultrasonography. Receives: Other: Traditional didactic teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite learning score
Evaluating the self-assessed theoretical knowledge (10 points), self-assessed practical skills (20 points), self-assessed satisfaction (10 points) and willingness to applicate the technique in future practice (10 points).
Measured: Up to 12 hours after ultrasound scan is finished
Secondary outcomes (3)
Time of scan
Defined as the time from the probe contacting the skin to acquiring the three key ultrasound views
Measured: Up to 1 hour after ultrasound scan begins
Rate of anatomic structures recognition
The correct rate of recognition among 12 anatomic structures (posterior complex, anterior complex, lamina and erector spinae in the parasagittal oblique interlaminar view, spinous process, lamina and erector spinae transverse spinous view, articular process, transverse process, posterior complex, anterior complex and spinal canal in the transverse interlaminar view)
Measured: Up to 12 hours after ultrasound scan is finished
Accuracy of depth measurement to the posterior complex
The measurement was deemed correct if the error was less than 0.5cm
Measured: Up to 12 hours after ultrasound scan is finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuraxial UltrasonographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874609
- Sponsor's protocol ID
- VR teaching
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05874609
- Acronym / sponsor ID
- VR teaching
- Conditions
- Neuraxial Ultrasonography
- Keywords
- ultrasound-guided, neuraxial anesthesia, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 May 2023 (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.
As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire. Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education. The aim of our study is to evaluate the practical skills of ultrasound scan and the satisfaction of students who undergo training using VR versus traditional didactic lecture.
Detailed description
This is a prospective, single-center, randomized control trial to evaluate the performance of spine ultrasound scan after different training methods. Participants were randomly divided into two groups receiving different training methods: VR spine simulator or traditional didactic teaching. After the training, participants were required to perform a preprocedural spine ultrasound scan on healthy volunteers using the stepwise technique taught in the didactic teaching session. The participants needed to acquire three key ultrasound views during the scan and recognize the anatomic structures in three ultrasound views.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: Teaching with VR spine simulatorIn the VR group, the participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session. |
| Control group | Active comparator | Other: Traditional didactic teachingIn the control group, the participants received a 30-min traditional didactic teaching session of spine ultrasonography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- anesthesia residents in our department
Key exclusion criteria (2 listed)
- having previous experience of spine ultrasonography training
- having previous experience of spine ultrasound scan.
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 |
|---|---|---|
| Teaching with VR spine simulatorThe participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session. The learning objective with the VR simulator is to review the 3D lumbar spine anatomic model，learn the sonoanatomy presented by a dynamic ultrasound scan of the sagittal and transverse plane, and practice a preprocedural ultrasound scan. | Other | VR group |
| Traditional didactic teachingA 30-min traditional didactic teaching session of spine ultrasonography. This session was consisted of general spine anatomy, sonographic technique and sonoanatomy, description of five key spine ultrasonographic views (transverse spinous process view, transverse interlaminar view, parasagittal oblique interlaminar view, parasagittal articular process view, parasagittal transverse process view), and a stepwise technique of preprocedural lumbar spine scan | Other | Control group |
Primary outcome
Composite learning score
Time frame: Up to 12 hours after ultrasound scan is finished
Evaluating the self-assessed theoretical knowledge (10 points), self-assessed practical skills (20 points), self-assessed satisfaction (10 points) and willingness to applicate the technique in future practice (10 points).
3 secondary outcomes
Time of scan
Time frame: Up to 1 hour after ultrasound scan begins
Rate of anatomic structures recognition
Time frame: Up to 12 hours after ultrasound scan is finished
Accuracy of depth measurement to the posterior complex
Time frame: Up to 12 hours after ultrasound scan is finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching with VR spine simulator and Traditional didactic teaching in people with Neuraxial Ultrasonography, run by Peking Union Medical College Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Composite learning score (time frame: Up to 12 hours after ultrasound scan is finished). 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 25 May 2023.