Development and Validation of a Virtual Teaching Method f... | NCT06355596

Studies
Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills

NCT06355596

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Surgery

Interventions

Virtual teaching

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2022Actual

Primary Completion Date

Apr 8, 2022Actual

Completion Date

Apr 8, 2022Actual

First Submitted Date

Mar 19, 2024

First Submission Date that Met QC Criteria

Apr 4, 2024

First Posted Date

Apr 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:

Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?

Participants in this study will:

Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.

Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Face-to-face teaching	Active Comparator	Face-to-face teaching of laparoscopic skills	Other: Virtual teaching
Virtual teaching	Experimental	Virtual teaching of laparoscopic skills	Other: Virtual teaching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual teaching	Other	Virtual teaching of laparoscopic skills	Face-to-face teaching Virtual teaching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score	Time to completion of task (minutes)	Two days
European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score	Time to completion of task (minutes)	Two days

Secondary Outcomes

Measure	Description	Time Frame
SURG-TLX score	Workload score ranging from 0 to 100	Two days
Heart rate	Beats per minute	Two days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (age > 18)
Medical student, Foundation Year or Core Trainee level or equivalent

Exclusion Criteria:

Specialty Registrar level
Consultant level

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Mary's Hospital		London		W2 1NY	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided