Clinical trial NCT03721094: Training Using Immersive Virtual Reality
Official title: Cognitive Load and Performance in Immersive Virtual Reality Versus Conventional Virtual Reality Simulation Training of Laparoscopic Surgery - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Load, Performance
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center randomized trial was designed according to the CONSORT statement
Primary purpose: OTHER

Brief summary: In this study, the investigators examine the cognitive load (CL) and performance of a laparoscopic procedure in immersive virtual reality and controlled virtual reality in a randomized, controlled setup. Virtual reality (VR) simulators combined with head mounted displays (HMDs) enable highly immersive virtual reality (IVR) for surgical skills training, potentially bridging the gap between the simulation environment and real-life operating room (OR) conditions. However, the increased complexity of the learning situation in IVR could potentially induce high CL thereby inhibiting performance and learning.


Eligibility criteria: Inclusion Criteria:

* First year resident

Exclusion Criteria:

* Previous participation in trials involving laparoscopic training
* Prior experience with laparoscopic surgery (having performed one or more laparoscopic procedures as primary surgeon, including supervised procedures)
* Not speaking Danish on a conversational level

Primary outcomes:
measure: Cognitive load
timeFrame: 6 months
Secondary outcomes:
measure: Time to completion of procedure
timeFrame: 6 months
measure: Diathermy damage
timeFrame: 6 months
measure: Blood loss
timeFrame: 6 months
measure: Efficience of instrument movements (length)
timeFrame: 6 months
measure: Efficience of instrument movements (degrees)
timeFrame: 6 months
Other outcomes:
measure: Motion sickness
timeFrame: 6 months
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Academy for Medical Education and Simulation
state: Østerbro
Study officials:
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Lars Konge, PhD
role: STUDY_DIRECTOR
References:
citation: Sorensen SM, Savran MM, Konge L, Bjerrum F. Three-dimensional versus two-dimensional vision in laparoscopy: a systematic review. Surg Endosc. 2016 Jan;30(1):11-23. doi: 10.1007/s00464-015-4189-7. Epub 2015 Apr 4.
citation: Nagendran M, Gurusamy KS, Aggarwal R, Loizidou M, Davidson BR. Virtual reality training for surgical trainees in laparoscopic surgery. Cochrane Database Syst Rev. 2013 Aug 27;2013(8):CD006575. doi: 10.1002/14651858.CD006575.pub3.
citation: Moorthy K, Munz Y, Adams S, Pandey V, Darzi A. A human factors analysis of technical and team skills among surgical trainees during procedural simulations in a simulated operating theatre. Ann Surg. 2005 Nov;242(5):631-9. doi: 10.1097/01.sla.0000186298.79308.a8.
citation: van Merrienboer JJ, Sweller J. Cognitive load theory in health professional education: design principles and strategies. Med Educ. 2010 Jan;44(1):85-93. doi: 10.1111/j.1365-2923.2009.03498.x.
citation: Huber T, Paschold M, Hansen C, Wunderling T, Lang H, Kneist W. New dimensions in surgical training: immersive virtual reality laparoscopic simulation exhilarates surgical staff. Surg Endosc. 2017 Nov;31(11):4472-4477. doi: 10.1007/s00464-017-5500-6. Epub 2017 Apr 4.
citation: Andersen SA, Mikkelsen PT, Konge L, Caye-Thomasen P, Sorensen MS. Cognitive Load in Mastoidectomy Skills Training: Virtual Reality Simulation and Traditional Dissection Compared. J Surg Educ. 2016 Jan-Feb;73(1):45-50. doi: 10.1016/j.jsurg.2015.09.010. Epub 2015 Oct 21.
citation: Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
citation: Thorson CM, Kelly JP, Forse RA, Turaga KK. Can we continue to ignore gender differences in performance on simulation trainers? J Laparoendosc Adv Surg Tech A. 2011 May;21(4):329-33. doi: 10.1089/lap.2010.0368.
citation: White MT, Welch K. Does gender predict performance of novices undergoing Fundamentals of Laparoscopic Surgery (FLS) training? Am J Surg. 2012 Mar;203(3):397-400; discussion 400. doi: 10.1016/j.amjsurg.2011.09.020.
citation: Gianaros PJ, Muth ER, Mordkoff JT, Levine ME, Stern RM. A questionnaire for the assessment of the multiple dimensions of motion sickness. Aviat Space Environ Med. 2001 Feb;72(2):115-9.