Training Using Immersive Virtual Reality

NCT03721094 | Completed

• 1 other identifier: HMD-VR
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Load, Performance

Outcome Measures

Primary Outcomes (1)

• Cognitive load

  Measurement of the participants cognitive load during four different time periods during the three procedures. Cognitive load was estimated by secondary-task reaction time. The investigators used an external and commercially available reaction timer (American Educational Products LLC, USA) to measure participants response time (in hundreds seconds) to an auditory stimulus (a beep). Reaction time was measured before and after the simulation to provide an individual baseline, and during the simulation at t=80 s, t=130 s, t=180 s and t=240 s. All reaction time measurements were done in series of four repeated measurements. It was also noted if the reaction time was measured while the participant was using the foot pedal for cauterization in the simulation.

  6 months

Secondary Outcomes (5)

• Time to completion of procedure

  6 months

• Diathermy damage

  6 months

• Blood loss

  6 months

• Efficience of instrument movements (length)

  6 months

• Efficience of instrument movements (degrees)

  6 months

Other Outcomes (1)

• Motion sickness

  6 months

Study Arms (2)

Immersive virtual reality

OTHER

Completing the procedures in immersive virtual reality

Other: Immersive virtual reality

Conventional virtual reality

NO INTERVENTION

Completing the procedures in conventional virtual reality

Interventions

Immersive virtual reality OTHER

In the IVR environment, four different 360-degrees videos were in sequence played as backdrop during the procedure. The videos reflected real life situations in the operating room with two videos representing calm periods, one video representing a light stressor and one video representing a severe stressor with a bleeding (2 ml/s) being triggered in the simulation. Participants complete the procedures while wearing the head mounted device.

Immersive virtual reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First year resident

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (10)

• 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.

  PMID: 25840896 BACKGROUND

• 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.

  PMID: 23980026 BACKGROUND

• 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.

  PMID: 16244534 BACKGROUND

• 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.

  PMID: 20078759 BACKGROUND

• 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.

  PMID: 28378077 BACKGROUND

• 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.

  PMID: 26481267 BACKGROUND

• 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.

  PMID: 23295321 BACKGROUND

• 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.

  PMID: 21563940 BACKGROUND

• 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.

  PMID: 22364906 BACKGROUND

• 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.

  PMID: 11211039 BACKGROUND

Study Officials

• Lars Konge, PhD

  Copenhagen Academy for Medical Education and Simulation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and the principal investigators were blinded to performance metrics by the simulator during the supervised procedure and the three test procedures. Participants and the data collector could not be blinded to the allocation/intervention. The investigator in charge of the statistical analysis was blinded to participants' group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-center randomized trial was designed according to the CONSORT statement

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 26, 2018
• Study Start: February 14, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)