Transvaginal Ultrasound ScanNCT02757599
Top-down Versus Bottom-up Transvaginal Ultrasound Scan
A study testing Ultrasound training in people with Transvaginal Ultrasound Scan, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Background: Transvaginal ultrasound training of novices is performed differently with respect to the orientation of the ultrasound image. There is no international consensus on the orientation of the transvaginal ultrasound image and no evidence to support whether one orientation is superior to the other in terms of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transvaginal Ultrasound Scan
- What is being tested?
- Ultrasound training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jun 2017
- 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
- are medical students from year 3 to year 6
- provide written informed consent.
Who cannot join
- 1) Have previous ultrasound experience besides a mandatory ultrasound course of four hours provided at the 6th semester for medical students at the University of Copenhagen
About this study
Official title: Impact of Image Orientation During Transvaginal Ultrasound on Learning: A Randomized Trial
Background: Transvaginal ultrasound training of novices is performed differently with respect to the orientation of the ultrasound image. There is no international consensus on the orientation of the transvaginal ultrasound image and no evidence to support whether one orientation is superior to the other in terms of educational outcome and learning curves.
The aim of this study is to assess the effects of transvaginal ultrasound training when orienting the image top-down versus bottom-up, which can open for the discussion concerning a uniform transvaginal ultrasound education. This study may improve ultrasound novices' learning and potentially ensure that future clinicians perform transvaginal ultrasound examinations in the same manner.
Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound novices, as the most intuitive will result in lower cognitive load during training and result in shorter learning curves and improved transfer of skills to various settings and cases.
Read the detailed description
Background
Ultrasonography is considered safe but highly operator dependent. Ultrasonography is being used increasingly in gynecology and obstetrics; however the training of novices in transvaginal ultrasound is performed differently with respect to the orientation of the ultrasound image, which often differs between operators and institutions. The image may be oriented top- down (transducer at the top) or bottom-up (transducer at the bottom). The different orientations of the image are a challenge for novices when being supervised by senior clinicians with different preferences for image orientation. As for now, there is no international consensus on image orientation and there is no evidence to support the superiority of one over the other in terms of learning curves and educational outcomes such as skills transfer. Transvaginal ultrasound is, like all other kinds of ultrasound, associated with long learning curves and is therefore time-consuming and requires extensive training. Transvaginal ultrasound is often associated with some discomfort to the patient, which can be reduced with adequate initial training. It therefore seems reasonable to determine how to provide the most effective initial transvaginal ultrasound training to reduce unnecessary patient discomfort and improve diagnostic accuracy through accelerated learning curves.
A recent study involving laparoscopic training, suggests that novices learn best from simplified practice during initial skills acquisition because it allows them to deal with future task complexity better than when being faced with complex image orientation. These findings are consistent with cognitive load theory, which emphasizes the limitations of the working memory when learning new tasks. Optimal learning occurs when the cognitive load of a new task is within the limits of the learner's working memory and when instructional features that do not contribute to learning are eliminated. Basic knobology (operating the ultrasound machine controls) and image interpretation represent significant sources of cognitive load for ultrasound novices and the acquisition of images should therefore be as simple as possible to avoid exceeding the working memory of the learner.
When looking at an ultrasound image, the operator transforms the two-dimensional ultrasound image into a three-dimensional internal representation of the structure being examined. Alignment of the image according to the physical angle of the transvaginal ultrasound probe by having the image facing bottom-up is by some clinicians perceived as the most intuitive anatomical orientation. Other clinicians prefer having the ultrasound image oriented the same way (top-down) regardless of the type of examination being performed (transabdominal or transvaginal).
The research question in this study is:
In a group of ultrasound novices, what is the effect of the transvaginal ultrasound training when orienting the image top-down versus bottom-up on learning curves and transfer of skills to different settings and cases?
Hypotheses:
The investigators hypothesize that the orientation perceived by ultrasound novices as the most intuitive will also result in shorter learning curves and improved transfer of skills. This study may improve ultrasound novices' learning and ensure that future clinicians perform transvaginal ultrasound examinations in the same manner. If the orientation of the image does not result in any changes to educational outcomes, there is no argument for adopting one approach over the other from an educational point-of-view.
Participants
Participants in this study are medical students from the University of Copenhagen, Denmark. Inclusion criteria require that participants 1) are medical students from year 3 to year 6; 2) have no previous ultrasound experience besides a mandatory ultrasound course of four hours provided at the 6th semester for medical students at the University of Copenhagen; and 3) provide written informed consent. Participants are after inclusion randomly divided into two study groups:
- Group one (TD): Orienting the transvaginal ultrasound image top-down
- Group two (BU): Orienting the transvaginal ultrasound image bottom-up
Randomization An independent research fellow at the Copenhagen Academy for Medical Education and Simulation, Rigshospitalet, randomizes participants by computer to either of the two groups.
Intervention Before any training is commenced, all participants are surveyed on their intuitive preferences for image orientation. Participants in both groups then receive a short theoretical introduction to pelvic ultrasound. Afterwards the participants are introduced to the simulated environment and the Virtual Reality (VR) simulator (Scantrainer) used for training. The VR simulator provides images obtained from real patients and haptic feedback from the ultrasound probe.
The study is based on the principle of mastery learning, thus participants are instructed to complete a simulator test that includes a number of practice modules until they have reached expert levels of performance. The expert performance level has been established in a previous validation study. Participants in the TD and BU groups are instructed with the ultrasound image top-down and bottom-up, respectively, throughout all training and assessment.
When the expert level is reached the participants perform a transfer test on the low-fidelity simulator (BluePhantom) within 7 days of completed simulator training. During the transfer test participants will be asked to complete a systematic ultrasound examination and to optimize the images during the scan. The performances will be videotaped and afterwards rated by two clinicians used to perform transvaginal ultrasound - one clinician used to seeing the ultrasound image top-down and the other clinician used to seeing the image bottom-up. The participants will be rated using the Objective Structured Assessment of Ultrasound Skills.
After completed training, participants are assessed on their cognitive load using a cognitive load questionnaire.
All training and assessments take place in the simulated setting in the skills lab at Copenhagen Academy for Medical Education and Simulation, Rigshospitalet.
Outcomes
Primary outcome:
- The primary outcome measures include learning curve for the two groups and performances during the transfer test. Learning curves are assessed through simulator scores obtained on the practice modules. A previous study has demonstrated that mastery learning levels are attained after four to five rounds of training on the practice modules included in the simulator test
Secondary outcomes:
- Participants' perception of the most intuitive approach before training.
- Time used within the two groups to reach expert level
- Cognitive load measurements using the instrument described by Leppink et al. after training
- Conditions
- Transvaginal Ultrasound Scan
- Being tested
- Ultrasound training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound trainingOther
Training on the transvaginal ultrasound simulator.
| Study group | Role | What they receive |
|---|---|---|
| Top-down (TD) | Other | The group having the transvaginal ultrasound image top-down. During training and transfer test. Receives: Other: Ultrasound training |
| Bottom-up (BU) | Other | The group having the transvaginal ultrasound image bottom-up. During training and transfer test. Receives: Other: Ultrasound training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve measured by time used for training
Measured: 6 months
Secondary outcomes (1)
Cognitive load, measured by a questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transvaginal Ultrasound ScanStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Amalie Taksoe-Vester, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Caroline A Taksoe-Vester, Bach.med, Principal investigator, Student teacher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757599
- Sponsor's protocol ID
- 12345
- Status last verified
- Jun 2017
- First submitted
- 18 Apr 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Image Orientation During Transvaginal Ultrasound on Learning: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02757599
- Acronym / sponsor ID
- 12345
- Conditions
- Transvaginal Ultrasound Scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
Background: Transvaginal ultrasound training of novices is performed differently with respect to the orientation of the ultrasound image. There is no international consensus on the orientation of the transvaginal ultrasound image and no evidence to support whether one orientation is superior to the other in terms of educational outcome and learning curves.
The aim of this study is to assess the effects of transvaginal ultrasound training when orienting the image top-down versus bottom-up, which can open for the discussion concerning a uniform transvaginal ultrasound education. This study may improve ultrasound novices' learning and potentially ensure that future clinicians perform transvaginal ultrasound examinations in the same manner.
Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound novices, as the most intuitive will result in lower cognitive load during training and result in shorter learning curves and improved transfer of skills to various settings and cases.
Detailed description
Background
Ultrasonography is considered safe but highly operator dependent. Ultrasonography is being used increasingly in gynecology and obstetrics; however the training of novices in transvaginal ultrasound is performed differently with respect to the orientation of the ultrasound image, which often differs between operators and institutions. The image may be oriented top- down (transducer at the top) or bottom-up (transducer at the bottom). The different orientations of the image are a challenge for novices when being supervised by senior clinicians with different preferences for image orientation. As for now, there is no international consensus on image orientation and there is no evidence to support the superiority of one over the other in terms of learning curves and educational outcomes such as skills transfer. Transvaginal ultrasound is, like all other kinds of ultrasound, associated with long learning curves and is therefore time-consuming and requires extensive training. Transvaginal ultrasound is often associated with some discomfort to the patient, which can be reduced with adequate initial training. It therefore seems reasonable to determine how to provide the most effective initial transvaginal ultrasound training to reduce unnecessary patient discomfort and improve diagnostic accuracy through accelerated learning curves.
A recent study involving laparoscopic training, suggests that novices learn best from simplified practice during initial skills acquisition because it allows them to deal with future task complexity better than when being faced with complex image orientation. These findings are consistent with cognitive load theory, which emphasizes the limitations of the working memory when learning new tasks. Optimal learning occurs when the cognitive load of a new task is within the limits of the learner's working memory and when instructional features that do not contribute to learning are eliminated. Basic knobology (operating the ultrasound machine controls) and image interpretation represent significant sources of cognitive load for ultrasound novices and the acquisition of images should therefore be as simple as possible to avoid exceeding the working memory of the learner.
When looking at an ultrasound image, the operator transforms the two-dimensional ultrasound image into a three-dimensional internal representation of the structure being examined. Alignment of the image according to the physical angle of the transvaginal ultrasound probe by having the image facing bottom-up is by some clinicians perceived as the most intuitive anatomical orientation. Other clinicians prefer having the ultrasound image oriented the same way (top-down) regardless of the type of examination being performed (transabdominal or transvaginal).
The research question in this study is:
In a group of ultrasound novices, what is the effect of the transvaginal ultrasound training when orienting the image top-down versus bottom-up on learning curves and transfer of skills to different settings and cases?
Hypotheses:
The investigators hypothesize that the orientation perceived by ultrasound novices as the most intuitive will also result in shorter learning curves and improved transfer of skills. This study may improve ultrasound novices' learning and ensure that future clinicians perform transvaginal ultrasound examinations in the same manner. If the orientation of the image does not result in any changes to educational outcomes, there is no argument for adopting one approach over the other from an educational point-of-view.
Participants
Participants in this study are medical students from the University of Copenhagen, Denmark. Inclusion criteria require that participants 1) are medical students from year 3 to year 6; 2) have no previous ultrasound experience besides a mandatory ultrasound course of four hours provided at the 6th semester for medical students at the University of Copenhagen; and 3) provide written informed consent. Participants are after inclusion randomly divided into two study groups:
- Group one (TD): Orienting the transvaginal ultrasound image top-down
- Group two (BU): Orienting the transvaginal ultrasound image bottom-up
Randomization An independent research fellow at the Copenhagen Academy for Medical Education and Simulation, Rigshospitalet, randomizes participants by computer to either of the two groups.
Intervention Before any training is commenced, all participants are surveyed on their intuitive preferences for image orientation. Participants in both groups then receive a short theoretical introduction to pelvic ultrasound. Afterwards the participants are introduced to the simulated environment and the Virtual Reality (VR) simulator (Scantrainer) used for training. The VR simulator provides images obtained from real patients and haptic feedback from the ultrasound probe.
The study is based on the principle of mastery learning, thus participants are instructed to complete a simulator test that includes a number of practice modules until they have reached expert levels of performance. The expert performance level has been established in a previous validation study. Participants in the TD and BU groups are instructed with the ultrasound image top-down and bottom-up, respectively, throughout all training and assessment.
When the expert level is reached the participants perform a transfer test on the low-fidelity simulator (BluePhantom) within 7 days of completed simulator training. During the transfer test participants will be asked to complete a systematic ultrasound examination and to optimize the images during the scan. The performances will be videotaped and afterwards rated by two clinicians used to perform transvaginal ultrasound - one clinician used to seeing the ultrasound image top-down and the other clinician used to seeing the image bottom-up. The participants will be rated using the Objective Structured Assessment of Ultrasound Skills.
After completed training, participants are assessed on their cognitive load using a cognitive load questionnaire.
All training and assessments take place in the simulated setting in the skills lab at Copenhagen Academy for Medical Education and Simulation, Rigshospitalet.
Outcomes
Primary outcome:
- The primary outcome measures include learning curve for the two groups and performances during the transfer test. Learning curves are assessed through simulator scores obtained on the practice modules. A previous study has demonstrated that mastery learning levels are attained after four to five rounds of training on the practice modules included in the simulator test
Secondary outcomes:
- Participants' perception of the most intuitive approach before training.
- Time used within the two groups to reach expert level
- Cognitive load measurements using the instrument described by Leppink et al. after training
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Top-down (TD) | Other | Other: Ultrasound trainingThe group having the transvaginal ultrasound image top-down. During training and transfer test. |
| Bottom-up (BU) | Other | Other: Ultrasound trainingThe group having the transvaginal ultrasound image bottom-up. During training and transfer test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- are medical students from year 3 to year 6
- provide written informed consent.
Key exclusion criteria (1 listed)
- 1) Have previous ultrasound experience besides a mandatory ultrasound course of four hours provided at the 6th semester for medical students at the University of Copenhagen
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 |
|---|---|---|
| Ultrasound trainingTraining on the transvaginal ultrasound simulator. | Other | Bottom-up (BU), Top-down (TD) |
Primary outcome
Learning curve measured by time used for training
Time frame: 6 months
1 secondary outcome
Cognitive load, measured by a questionnaire
Time frame: 6 months
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 20 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
Caroline A Taksoe-Vester, Bach.med principal investigator
Student teacher
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound training in people with Transvaginal Ultrasound Scan, run by Copenhagen University Hospital, Rigshospitalet.
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 2 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 20 Jun 2017. 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?
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?
Learning curve measured by time used for training (time frame: 6 months). 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 20 Jun 2017.