NCT05834374

Brief Summary

The goal of this randomized study is to investigate the effect of introducing contextual variation on transfer when learning a technical skill in a group of medical students. The main questions it aims to answer is: If context variation of specific affordance conditions enhance the learner's ability to transfer out? Participants will practice performing an invasive ultrasound guided procedure either on a fantom with maximum affordances or with contextual variation. Researchers will compare the maximum affordances group and the contextual variation group to see if its effects compared to the control group with minimal affordances.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 17, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 3, 2023

Last Update Submit

April 17, 2023

Conditions

Keywords

Medical educationAffordancesContextual variationInvasisve ultrasound skills

Outcome Measures

Primary Outcomes (1)

  • Transfertest score

    Exåpert based performances scores using a 5 point likert scale rating 4 items. Higher scores indicate better performance.

    4*7 min (4 tests) 7-10 days after intervention

Secondary Outcomes (1)

  • Training

    60 min (training session)

Study Arms (3)

Contextual variation

EXPERIMENTAL

The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide.

Other: Contextual variation

Maximum affordances

EXPERIMENTAL

The maximum affordances group has half the surface model covered and a complete guide throughout the session.

Other: Maximum affordances

Minimum affordances

NO INTERVENTION

The control group has the whole surface uncovered and no guide throughout the session.

Interventions

The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.

Also known as: Maximum affordances
Contextual variation

The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.

Maximum affordances

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Passed a general anatomy exam
  • Proficiency in Danish

You may not qualify if:

  • Previous ultrasound experience except mandatory training as part of the medical curriculum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy of Medical Education and Simulation

Copenhagen, Denmark

Location

Study Officials

  • Martin G Tolsgaard, Professor

    Rigshospitalet, Denmark

    STUDY CHAIR
  • Vilma L Johnsson, M.D.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 28, 2023

Study Start

March 17, 2021

Primary Completion

October 7, 2021

Study Completion

October 7, 2021

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Data can be shared upon request. However, raw data includes non-anonymized video records that are incompatible with sharing.

Locations