NCT03154372

Brief Summary

Purpose: The aim of this study was to compare the effects of deliberate vs. self-guided practices on acquiring needling skills by novice learners. Methods: Eighteen medical students were randomized to deliberate or self-guided practices groups. Following a learning phase, subjects attempted to perform a predefined task, which entitled advancing a needle towards a target on a phantom gel under ultrasound guidance. Subsequently, all subjects practiced performing the task using previously validated metrics. Subjects in the deliberate practice group were coached by an expert anesthesiologist and practiced each metric until it was satisfactorily performed based on the supervising anesthesiologist assessment. Immediately after completing the practice, all subjects attempted to perform same task, and on the following day, made two further attempts in succession. Two trained consultant anesthesiologists will use the metrics to independently score the video-recorded performances.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 20, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 12, 2017

Last Update Submit

May 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of steps completed and errors made

    averaged score of the two video assessors is calculated for number of steps completed and error made

    up to 24 hours

Study Arms (2)

deliberate practice

OTHER

expert supervised practice with validated metrics

Other: Expert supervised practice with validated metrics

self-guided practice

OTHER

self guided practice with validated metrics

Other: self guided practice with validated metrics

Interventions

Eligibility Criteria

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

You may qualify if:

  • rd and 4th year medical students

You may not qualify if:

  • previous performance of ultrasound guided procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

May 12, 2017

First Posted

May 16, 2017

Study Start

September 20, 2016

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05