Skip to main content
OpenTrials
Completed

NCT Number: NCT02069951

Procedure-to-procedure Transfer Trial

Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.

The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, DK2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
  • Obtained the bachelor degree in medicine.
  • Signed informed consent.

Exclusion criteria

  • Previous participation in trials involving laparoscopic training.
  • Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
  • No informed consent.
  • Does not speak Danish on a conversational level.

Treatment and study plan

Practice a procedural module on a simulator

Other

Primary outcomes

  1. The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator

    Time frame: Up to 26 weeks

    The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.

Secondary outcomes

  1. The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.

    Time frame: Up to 26 weeks

    The effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.

Other outcomes

  1. Subjective Mental Effort Question score after the 1st repetition

    Time frame: Up to 26 weeks

    To score the level of stress, all the participants will be required to the Subjective Mental Effort Questionnaire after the first repetition of a procedural module. The SMEQ is a cognitive workload questionnaire with a scale of 0 to 150 points

  2. Motor skills performance parameters

    Time frame: Up to 26 weeks

    • The total path length (cumulative distance tip movement for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.
    • The total angular path (cumulative angular degrees for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.
    • The total procedure time for the first attempt on procedural module B will be compared for the intervention and the control group.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Official study title

A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2014
Registry last updated
May 12, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.