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Cognitive Load, PerformanceNCT03721094

Training Using Immersive Virtual Reality

A study testing Immersive virtual reality in people with Cognitive Load, Performance, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Cognitive Load, Performance
What is being tested?
Immersive virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteDenmark
Study dates
14 Feb 2018to 5 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • First year resident

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen Academy for Medical Education and Simulation

    Copenhagen, Østerbro, 2100

Other trials in Denmark

About this study

Official title: 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.

Being tested
Immersive virtual reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive virtual realityOther

    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.

Study groups in NCT03721094
Study groupRoleWhat they receive
Immersive virtual realityOtherCompleting the procedures in immersive virtual reality
Receives: Other: Immersive virtual reality
Conventional virtual realityNo interventionCompleting the procedures in conventional virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)

  1. Time to completion of procedure

    Time to completion of procedure (measured in seconds)

    Measured: 6 months

  2. Diathermy damage

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

    Measured: 6 months

  3. Blood loss

    Blood loss during the procedure (in ml)

    Measured: 6 months

  4. Efficience of instrument movements (length)

    Measurement of movement of the left and right hand in meters

    Measured: 6 months

  5. Efficience of instrument movements (degrees)

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2018
  2. Study start14 Feb 2018
  3. Primary completion5 Jun 2018
  4. Study completion5 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single-center randomized trial was designed according to the CONSORT statement
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721094
Sponsor's protocol ID
HMD-VR
Status last verified
Nov 2018
First submitted
5 Oct 2018
Last updated
5 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25840896

  • 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.

    PubMed 23980026

  • 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.

    PubMed 16244534

  • 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.

    PubMed 20078759

  • 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.

    PubMed 28378077

  • 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.

    PubMed 26481267

  • 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.

    PubMed 23295321

  • 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.

    PubMed 21563940

  • 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.

    PubMed 22364906

  • 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.

    PubMed 11211039

Questions about this trial

What is this clinical trial studying?

A study testing Immersive virtual reality in people with Cognitive Load, Performance, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive load (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03721094, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.

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