The FEEDBACK Trial, a Randomized Controlled Trial (Feedback)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Copenhagen Trial Unit, Center for Clinical Intervention Research, Denmark
Information provided by (Responsible Party):
Jeanett Oestergaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01497782
First received: December 20, 2011
Last updated: December 21, 2011
Last verified: December 2011

December 20, 2011
December 21, 2011
April 2011
October 2011   (final data collection date for primary outcome measure)
Repetitions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator
Same as current
Complete list of historical versions of study NCT01497782 on ClinicalTrials.gov Archive Site
Time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator.
Same as current
Not Provided
Not Provided
 
The FEEDBACK Trial, a Randomized Controlled Trial
Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial

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.

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)

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Laparoscopic Proficiency
Other: Instructor feedback
Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
  • Experimental: Instructor feedback
    Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
    Intervention: Other: Instructor feedback
  • No Intervention: No instructor feedback
    Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
99
January 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01497782
H-3-2010-082 FEEDBACK
No
Jeanett Oestergaard, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research, Denmark
Principal Investigator: Jeanett Oestergaard, MD Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
Rigshospitalet, Denmark
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP