The FEEDBACK Trial, a Randomized Controlled Trial

Study Overview
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Brief Summary
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With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator. The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.

Detailed Description
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For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear. Throughout the last decade several studies have found a positive effect on the learning curve as well as improvement of basic psychomotor skills in the operating room after VR training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from simple basic skills training to full procedures such as a cholecystectomy or salpingectomy. Despite the now well-established advantages of VR simulators, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training in the surgical education. This is mainly due to lack of knowledge concerning the time and human resources/cost needed to train novice surgeons to an adequate level. This randomized trial investigates whether instructor feedback is pivotal for the trainee when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor feedback consists of standardized feedback for ten minutes and with a maximum of three optional feedback sessions; the trainees (in the intervention group) decides them selves when they want a feedback session. The trainees in both the control group and the intervention group have to reach a predefined proficiency level on the VR simulator within 8 weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different learning approaches, e.g. a self-directed approach and an independent approach. The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark. Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours annually)

Official Title
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Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial

Conditions
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Laparoscopic Proficiency

Intervention / Treatment
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* Other: Instructor feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical student at Copenhagen University with passed bachelor degree Signed informed consent Exclusion Criteria: Prior experience with surgical virtual reality simulators > 3 independent laparoscopic procedures Not fluent in the Danish language
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instructor feedback<br>Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. | Other: Instructor feedback<br>* Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.<br>|
| No Intervention: No instructor feedback<br>Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repetitions | Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, simulator, feedback, laparoscopy, training