NCT02757599

Brief Summary

Background: Transvaginal ultrasound training of novices is performed differently with respect to the orientation of the ultrasound image. There is no international consensus on the orientation of the transvaginal ultrasound image and no evidence to support whether one orientation is superior to the other in terms of educational outcome and learning curves. The aim of this study is to assess the effects of transvaginal ultrasound training when orienting the image top-down versus bottom-up, which can open for the discussion concerning a uniform transvaginal ultrasound education. This study may improve ultrasound novices' learning and potentially ensure that future clinicians perform transvaginal ultrasound examinations in the same manner. Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound novices, as the most intuitive will result in lower cognitive load during training and result in shorter learning curves and improved transfer of skills to various settings and cases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

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

April 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

April 18, 2016

Last Update Submit

June 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Learning curve measured by time used for training

    6 months

Secondary Outcomes (1)

  • Cognitive load, measured by a questionnaire

    6 months

Study Arms (2)

Top-down (TD)

OTHER

The group having the transvaginal ultrasound image top-down. During training and transfer test.

Other: Ultrasound training

Bottom-up (BU)

OTHER

The group having the transvaginal ultrasound image bottom-up. During training and transfer test.

Other: Ultrasound training

Interventions

Training on the transvaginal ultrasound simulator.

Bottom-up (BU)Top-down (TD)

Eligibility Criteria

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

You may qualify if:

  • are medical students from year 3 to year 6
  • provide written informed consent.

You may not qualify if:

  • \) Have previous ultrasound experience besides a mandatory ultrasound course of four hours provided at the 6th semester for medical students at the University of Copenhagen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Caroline A Taksoe-Vester, Bach.med

    Student teacher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stud.med

Study Record Dates

First Submitted

April 18, 2016

First Posted

May 2, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share