NCT01703975

Brief Summary

Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of medical health care providers. However, training costs are considerable and may be optimized using interventions to improve learning. The aim of this study is to compare the effects of training in pairs versus training alone on an VR ultrasound simulator. Methods: 30 medical students in their final year are randomized to either training in pairs or training alone. All participants are trained for two hours. Subsequently, all students are assessed on ultrasound performance on real patients in an ambulatory setting. Performance is assessed using a rating scale that has been validated in a previous study by two blinded assessors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

October 8, 2012

Last Update Submit

June 26, 2013

Conditions

Learning OutcomeTraining Efficiency

Keywords

Simulation efficiencyCollaborative learning

Outcome Measures

Primary Outcomes (1)

  • Performance test

    The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded OB/GYN consultant rated performance using a previously validated rating scale.Sample size calculation and statistical methods.

    6 hours

Secondary Outcomes (1)

  • Confidence

    6 hours

Study Arms (2)

Single training

NO INTERVENTION

Students training alone on the simulator

Training in pairs (Dyad Training)

EXPERIMENTAL

Students training in pairs on the simulator

Other: Training in pairs (Dyad training)

Interventions

Training in pairs (Dyad training)OTHER
Training in pairs (Dyad Training)

Eligibility Criteria

Age20 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Final year medical students

You may not qualify if:

  • Prior extra-curricular ultrasound experience.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Fetal Medicine, Juliane Marie Centre

Copenhagen O, 2100, Denmark

Location

Study Design

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

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

DK(1)