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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
History of Changes
  Purpose

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.


Condition Intervention
Laparoscopic Proficiency
 Other: Instructor feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator.


Enrollment: 99
Study Start Date: April 2011
Estimated Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.

Detailed Description:

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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497782

Locations
Denmark
Rigshospitalet, University Hospital of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research, Denmark
Investigators
Principal Investigator: Jeanett Oestergaard, MD Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
  More Information

Additional Information:
Website for VR simulation information, including information about the FEEDBACK Trial (in Danish)  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeanett Oestergaard, MD, PhD fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01497782     History of Changes
Other Study ID Numbers: H-3-2010-082 FEEDBACK
Study First Received: December 20, 2011
Last Updated: December 21, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
virtual reality, simulator, feedback, laparoscopy, training

ClinicalTrials.gov processed this record on May 23, 2013