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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Denmark

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.

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 groups in NCT01703975
Study groupRoleWhat they receive
Single trainingNo interventionStudents training alone on the simulator
Training in pairs (Dyad Training)ExperimentalStudents 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.

  1. 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)
  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.

  1. First posted11 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

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)
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

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.

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