NCT05731674

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

June 30, 2022

Last Update Submit

February 7, 2023

Conditions

Skilss Acquisition for Virtual Reality Laparoscopic Training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time (minutes) to reach the predefined proficiency settings for the basic skills

    6 weeks

  • Time (minutes) to reach proficiency setting for the procedural module (salpingectomy due to an ectopic bleeding)

    6 weeks

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Other: Random selection of excercises

Interventions

Random selection of excercisesOTHER

Participants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program.

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical Students enrolled at a Danish University

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMES

Copenhagen, 2100, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research scholar, Bsc. in Medicine

Study Record Dates

First Submitted

June 30, 2022

First Posted

February 16, 2023

Study Start

September 15, 2022

Primary Completion

September 15, 2022

Study Completion

January 1, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

DK(1)