Training Using Immersive Virtual Reality

November 1, 2018 updated by: Joakim Grant Frederiksen, Copenhagen Academy for Medical Education and Simulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2100
        • Copenhagen Academy for Medical Education and Simulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Immersive virtual reality
Completing the procedures in immersive virtual reality
Other: Immersive virtual reality
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.
NO_INTERVENTION: Conventional virtual reality
Completing the procedures in conventional virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to completion of procedure
Time Frame: 6 months
Time to completion of procedure (measured in seconds)
6 months
Diathermy damage
Time Frame: 6 months
Damage to surrounding tissue during the procedure (in number of incidents)
6 months
Blood loss
Time Frame: 6 months
Blood loss during the procedure (in ml)
6 months
Efficience of instrument movements (length)
Time Frame: 6 months
Measurement of movement of the left and right hand in meters
6 months
Efficience of instrument movements (degrees)
Time Frame: 6 months
Measurement of angular movements of the left and right hand in degrees
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Academy for Medical Education and Simulation

Investigators

  • Study Director: Lars Konge, PhD, Copenhagen Academy for Medical Education and Simulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2018

Primary Completion (ACTUAL)

June 5, 2018

Study Completion (ACTUAL)

June 5, 2018

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (ACTUAL)

October 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HMD-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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