Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01703975 |
| Other study ID # |
DRVK-35596 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 8, 2012 |
| Last updated |
June 26, 2013 |
| Start date |
January 2013 |
| Est. completion date |
June 2013 |
Study information
| Verified date |
June 2013 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: Regional Ethical Comitee of the Capital Region |
| Study type |
Interventional
|
Clinical 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. 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.
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.
