Learning OutcomeNCT01703975
The Effects of Virtual Reality Ultrasound Training in Pairs Compared to Training Alone
A study testing Training in pairs (Dyad training) in people with Learning Outcome and Training Efficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of medical health care providers. However, training costs are considerable and may be optimized using interventions to improve learning. Read more about this study
- Who is it for?
- Ages 20 months and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Outcome, Training Efficiency
- What is being tested?
- Training in pairs (Dyad training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2013
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Final year medical students
Who cannot join
- Prior extra-curricular ultrasound experience.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Fetal Medicine, Juliane Marie Centre
Copenhagen O, 2100
About this study
Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of medical health care providers. However, training costs are considerable and may be optimized using interventions to improve learning. The aim of this study is to compare the effects of training in pairs versus training alone on an VR ultrasound simulator.
Methods: 30 medical students in their final year are randomized to either training in pairs or training alone. All participants are trained for two hours. Subsequently, all students are assessed on ultrasound performance on real patients in an ambulatory setting. Performance is assessed using a rating scale that has been validated in a previous study by two blinded assessors.
Read the detailed description
Ultrasound is becoming increasingly used in many medical specialties. However, the quality of the ultrasound examination is highly operator dependent and sufficient training of clinicians is challenging. Virtual Reality ultrasound simulation enables training under controlled conditions and it allows trainees to make mistakes before practicing on patients. However, this type of training is expensive due to costs of simulators and clinician supervisors to provide instructions and feedback while the trainees are practicing. Training in pairs, also known as dyad training, may provide a learning advantage to trainees due to shared memory and increased confidence. Moreover, dyad training allows training twice the number of trainees on simulators, which has implications to the cost-effectiveness of VR simulation.
In this study, we examine non-inferiority of dyad training compared to the effect of traditional training based on clinician instruction using a VR ultrasound simulator.
Methods Study design. A randomized observer-blinded non-inferiority study in which training in pairs is compared to training alone on a VR simulator.
Pilot study. Two pilot studies were conducted to determine which modules to include in the training curriculum and how to provide a standardized instruction of trainees. The first pilot study included 10 OB/GYN residents and 10 OB/GYN consultants, who rated and commented each module with regards to how useful they were to pelvic ultrasound training. These ratings were used to develop a training curriculum consisting of a series of basic gynecologic training modules. The second pilot study included 6 medical students, of which half trained in pairs and the other half trained alone with clinician instructions. This enabled the research team to develop a template for the instruction that should be provided by clinician instructors in the group of participants that practiced alone.
Participants. Year-six medical students in their final rotations before entering residency enrolled in this study. The only exclusion criterion was previous ultrasound courses or extra-curricular ultrasound training. 30 participants were enrolled to ensure that at least 24 completed the transfer test.
Setting. All participants are trained on a VR ultrasound simulator (Scantrainer, Medaphor) in an OB/GYN clerkship site. The Scantrainer is a high-fidelity vaginal ultrasound simulator that provides haptic feedback and realistic imaging.
Randomization. All students were randomized to either training in pairs or training alone. Randomization was conducted at a different clinical department using computer-generated list of random numbers.
Intervention. All students received 30 minutes of introduction to the simulator including a short introduction to vaginal ultrasound examination. The simulator instruction was provided using a standardized template developed in the pilot study. Constructive feedback was provided when participants encountered problems that they wanted feedback on. The instructor was a clinician ultrasound simulation expert. The participants in the intervention group did not receive any continuous instructor support but were allowed to consult an instructor whenever the participants encountered a module that they could not pass. The total training time was two hours in both groups. Hence, participants in the dyad group received half the 'hands-on' time as the participants in the control group.
Outcome measure. The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded gynecologist rated performance using a previously validated rating scale.
Sample size calculation. Based on a previous construct validation study, a difference in performance scores corresponding to two months of clinical experience was regarded as significant, which corresponded a 4.6% difference. Using a SD of 0.2, a power of 0.80 and an alpha of 0.05, the total number of participants required was 24.
- Conditions
- Learning Outcome, Training Efficiency
- Being tested
- Training in pairs (Dyad training)
- Keywords
- Simulation efficiency, Collaborative learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in pairs (Dyad training)Other
| Study group | Role | What they receive |
|---|---|---|
| Single training | No intervention | Students training alone on the simulator |
| Training in pairs (Dyad Training) | Experimental | Students training in pairs on the simulator Receives: Other: Training in pairs (Dyad training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance test
The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded OB/GYN consultant rated performance using a previously validated rating scale.Sample size calculation and statistical methods.
Measured: 6 hours
Secondary outcomes (1)
Confidence
Students' confidence in managing the vaginal ultrasound examination are assessed after the post-intervention performance tests
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning OutcomeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Martin G. Tolsgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703975
- Sponsor's protocol ID
- DRVK-35596
- Status last verified
- Jun 2013
- First submitted
- 8 Oct 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality Ultrasound Training in Pairs Compared to Training Alone
- ClinicalTrials.gov ID
- NCT01703975
- Acronym / sponsor ID
- DRVK-35596
- Conditions
- Learning Outcome, Training Efficiency
- Keywords
- Simulation efficiency, Collaborative learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Oct 2012 (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.
Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of medical health care providers. However, training costs are considerable and may be optimized using interventions to improve learning. The aim of this study is to compare the effects of training in pairs versus training alone on an VR ultrasound simulator.
Methods: 30 medical students in their final year are randomized to either training in pairs or training alone. All participants are trained for two hours. Subsequently, all students are assessed on ultrasound performance on real patients in an ambulatory setting. Performance is assessed using a rating scale that has been validated in a previous study by two blinded assessors.
Detailed description
Ultrasound is becoming increasingly used in many medical specialties. However, the quality of the ultrasound examination is highly operator dependent and sufficient training of clinicians is challenging. Virtual Reality ultrasound simulation enables training under controlled conditions and it allows trainees to make mistakes before practicing on patients. However, this type of training is expensive due to costs of simulators and clinician supervisors to provide instructions and feedback while the trainees are practicing. Training in pairs, also known as dyad training, may provide a learning advantage to trainees due to shared memory and increased confidence. Moreover, dyad training allows training twice the number of trainees on simulators, which has implications to the cost-effectiveness of VR simulation.
In this study, we examine non-inferiority of dyad training compared to the effect of traditional training based on clinician instruction using a VR ultrasound simulator.
Methods Study design. A randomized observer-blinded non-inferiority study in which training in pairs is compared to training alone on a VR simulator.
Pilot study. Two pilot studies were conducted to determine which modules to include in the training curriculum and how to provide a standardized instruction of trainees. The first pilot study included 10 OB/GYN residents and 10 OB/GYN consultants, who rated and commented each module with regards to how useful they were to pelvic ultrasound training. These ratings were used to develop a training curriculum consisting of a series of basic gynecologic training modules. The second pilot study included 6 medical students, of which half trained in pairs and the other half trained alone with clinician instructions. This enabled the research team to develop a template for the instruction that should be provided by clinician instructors in the group of participants that practiced alone.
Participants. Year-six medical students in their final rotations before entering residency enrolled in this study. The only exclusion criterion was previous ultrasound courses or extra-curricular ultrasound training. 30 participants were enrolled to ensure that at least 24 completed the transfer test.
Setting. All participants are trained on a VR ultrasound simulator (Scantrainer, Medaphor) in an OB/GYN clerkship site. The Scantrainer is a high-fidelity vaginal ultrasound simulator that provides haptic feedback and realistic imaging.
Randomization. All students were randomized to either training in pairs or training alone. Randomization was conducted at a different clinical department using computer-generated list of random numbers.
Intervention. All students received 30 minutes of introduction to the simulator including a short introduction to vaginal ultrasound examination. The simulator instruction was provided using a standardized template developed in the pilot study. Constructive feedback was provided when participants encountered problems that they wanted feedback on. The instructor was a clinician ultrasound simulation expert. The participants in the intervention group did not receive any continuous instructor support but were allowed to consult an instructor whenever the participants encountered a module that they could not pass. The total training time was two hours in both groups. Hence, participants in the dyad group received half the 'hands-on' time as the participants in the control group.
Outcome measure. The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded gynecologist rated performance using a previously validated rating scale.
Sample size calculation. Based on a previous construct validation study, a difference in performance scores corresponding to two months of clinical experience was regarded as significant, which corresponded a 4.6% difference. Using a SD of 0.2, a power of 0.80 and an alpha of 0.05, the total number of participants required was 24.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single training | No intervention | –Students training alone on the simulator |
| Training in pairs (Dyad Training) | Experimental | Other: Training in pairs (Dyad training)Students training in pairs on the simulator |
Who may qualify
- Ages
- 20 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Final year medical students
Key exclusion criteria (1 listed)
- Prior extra-curricular ultrasound experience.
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 |
|---|---|---|
| Training in pairs (Dyad training) | Other | Training in pairs (Dyad Training) |
Primary outcome
Performance test
Time frame: 6 hours
The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded OB/GYN consultant rated performance using a previously validated rating scale.Sample size calculation and statistical methods.
1 secondary outcome
Confidence
Time frame: 6 hours
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 27 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in pairs (Dyad training) in people with Learning Outcome and Training Efficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 27 Jun 2013. 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 Denmark. 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?
Performance test (time frame: 6 hours). 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 27 Jun 2013.