Anesthesiology TraineeNCT03516058
Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
A study testing Simulation-Based Education in people with Anesthesiology Trainee, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model. The residents filled out a questionnaire before and after the training session. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Anesthesiology Trainee
- What is being tested?
- Simulation-Based Education
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2018to 1 Aug 2018
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants included second-year residents, third-year residents who can participate in the anesthesiology simulation training.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
The purpose of this study was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model.
The residents filled out a questionnaire before and after the training session. The questionnaires consisted of knowledge including ultrasound anatomy and block technique, comfort, confidence, and axiety levels for the TAP block.
- Conditions
- Anesthesiology Trainee
- Being tested
- Simulation-Based Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based EducationOther
Participating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session.
The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training.
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 1 week after training session
impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 2 months after training session
impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 1 week after training session
impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 2 months after training session
impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 1 week after training session
impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
Measured: within 2 months after training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesiology TraineeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516058
- Sponsor's protocol ID
- 4-2018-0208
- Status last verified
- Feb 2019
- First submitted
- 23 Apr 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
- ClinicalTrials.gov ID
- NCT03516058
- Acronym / sponsor ID
- 4-2018-0208
- Conditions
- Anesthesiology Trainee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 May 2018 (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 was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model.
The residents filled out a questionnaire before and after the training session. The questionnaires consisted of knowledge including ultrasound anatomy and block technique, comfort, confidence, and axiety levels for the TAP block.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants included second-year residents, third-year residents who can participate in the anesthesiology simulation training.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Simulation-Based EducationParticipating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session. The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training. | Other | – |
Primary outcome
impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
Time frame: within 1 week after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
Time frame: within 2 months after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
Time frame: within 1 week after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
Time frame: within 2 months after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
Time frame: within 1 week after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
Time frame: within 2 months after training session
5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high
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 11 Feb 2019.
- Individual participant dataSharing planned: No
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 Simulation-Based Education in people with Anesthesiology Trainee, run by Yonsei University 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 11 Feb 2019. 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?
impact of a simulation-based ultrasound-guided TAP block training session_Comfort level (time frame: within 1 week after training session). The study lists 6 primary outcomes in all. 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 11 Feb 2019.