Varied Practice on LAPSIM

Random Selection of Exercises Versus Self-Directed Training, for Laparoscopic Simulator Training - a Randomized Trial

To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training.

Study Overview

• Status: Completed
• Conditions: Skilss Acquisition for Virtual Reality Laparoscopic Training
• Intervention / Treatment: Other: Random selection of excercises

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • CAMES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical Students enrolled at a Danish University

Exclusion Criteria:

• Not being enrolled at a medical program at a Danish University, having participated in other virtual reality studies regarding laparoscopy, have had training or practice in laparoscopy on either pigs or in the clinic, have any medical conditions that may hinder a standard learning process when it comes to skills acquisition (eg. parkinson's disease, limited eye-sight etc).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Other: Random selection of excercises; Participants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time (minutes) to reach the predefined proficiency settings for the basic skills and the procedural module after 3-6 weeks without laparoscopic training.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (minutes) to reach the predefined proficiency settings for the basic skills	To examine any difference in training time for the two groups over-all	6 weeks
Time (minutes) to reach proficiency setting for the procedural module (salpingectomy due to an ectopic bleeding)	To examine if there is any difference in training time (minutes) for the two-groups when practicing on the procedural module (salpingectomy due to an ectopic bleeding)	6 weeks

Collaborators and Investigators

• Sponsor: Copenhagen Academy for Medical Education and Simulation

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Varied Practice's on LAPSIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No