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OpenTrials
Completed

NCT Number: NCT03721094

Training Using Immersive Virtual Reality

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Østerbro, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cognitive load

    Time frame: 6 months

    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.

Secondary outcomes

  1. Time to completion of procedure

    Time frame: 6 months

    Time to completion of procedure (measured in seconds)

  2. Diathermy damage

    Time frame: 6 months

    Damage to surrounding tissue during the procedure (in number of incidents)

  3. Blood loss

    Time frame: 6 months

    Blood loss during the procedure (in ml)

  4. Efficience of instrument movements (length)

    Time frame: 6 months

    Measurement of movement of the left and right hand in meters

  5. Efficience of instrument movements (degrees)

    Time frame: 6 months

    Measurement of angular movements of the left and right hand in degrees

Other outcomes

  1. Motion sickness

    Time frame: 6 months

    Motion sickness was assessed using a post-procedure questionnaire. The investigators used the MSAQ (Motion Sickness Assesment Questionnaire) developed by Gianaros et al in 2001. The questionnaire consisted of 16 statements and the participants had to rate how accurately the statements describe their experience in a numbered scale from 1 (not at all) to 9 (severely). The 16 statements were divided into for categories: Gastrointestinal; Central; Peripheral; Sopite-related. The overall motion sickness score was obtained by calculating the percentage of total points scored: (sum of points from all items/144) * 100. Subscale scores was obtained by calculating the percent of points scored within each factor: (sum of gastrointestinal items/36) * 100; (sum of central items/45) * 100; (sum of peripheral items/27) * 100; (sum of sopite-related items/36) * 100.

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Official study title

Cognitive Load and Performance in Immersive Virtual Reality Versus Conventional Virtual Reality Simulation Training of Laparoscopic Surgery - a Randomized Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2018
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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