Condition category
Surgery
Date applied
01/02/2012
Date assigned
20/02/2012
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urethral catheterisation (UC) is a procedure where a flexible tube called a catheter is inserted into a patient's bladder to collect urine. Inexperienced interns are responsible for most complications after UC. Although it is common to train using simulators, little is known about the transfer of learned skills to real clinical practice. The aim of this study is to evaluate the short- and long-term effects of a UC simulated skills training course on performance on real patients and to examine whether watching a video of the procedure immediately before assessment enhances performance.

Who can participate?
Third year students at University of Copenhagen medical school.

What does the study involve?
Participants attend a simulated skills training course covering the essential knowledge and skills needed to perform a UC. An experienced student teacher teaches the students in groups of maximum six. After a theoretical introduction, the major part of the course consists of practical training of UC on a mannequin with feedback from the teacher. After the UC course the students are tested using a mannequin. Their performance is videotaped and assessed afterwards. One to six weeks later, participants are scheduled to perform a UC on a real patient from a urological department. The UC procedure is assessed by direct observation by an experienced urology nurse, who could interrupt if anything potential harmful for the patient was going to happen.

What are the possible benefits and risks of participating?
There were no additional risks for the participants in our study.

When is the study starting and how long is it expected to run for?
May 2010 to March 2011

Where is the study run from?
University of Copenhagen (Denmark)

Who is funding the study?
University of Copenhagen (Denmark)

Who is the main contact?
Prof Charlotte Ringsted
charlotte.ringsted@rh.regionh.dk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Charlotte Ringsted

ORCID ID

Contact details

Bomhoffs Have 8
4. tv.
Copenhagen
1872
Denmark
-
charlotte.ringsted@rh.regionh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H-1-2010-075

Study information

Scientific title

Transfer of urethral catheterization (UC) skills from simulation training to performance on real clinical: a randomized controlled trial of the additional effect of video instruction

Acronym

Study hypothesis

The aims of the study were to investigate short- and long-term effects of simulated UC skills training on performance on real patients and the effect of watching an instructional video of the UC procedure immediately before the first clinical performance.

Ethics approval

The National Committee on Health Research Ethics, Copenhagen, Denmark, 13/08/2012, ref: H-1-2010-075

Study design

Single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Medical education

Intervention

The participants were randomised to a video group or a control group when they arrived at the hospital for the transfer-test.

The video group watched a five minutes long video instruction of urethral catheterization while the control group did not get any preparation before the test. The video illustrated a physician performing urethral catheterization on a real patient and a voice over to explain the difficult steps.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Urethral catheterization performance on patients were assessed using a form with 15 items, each to be scored on a scale of 0-4, where 4 indicated best performance

Secondary outcome measures

An overall assessment in the form including five categories: poor, unacceptable, acceptable, good, and excellent performance

Overall trial start date

01/05/2010

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

The participants were a volunteer sample of third year medical students at Copenhagen University. All students were invited by email to participate in the study and were included on a first come, first served principle

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Seventy-six medical students were enrolled in the main study. Twenty-eight medical students were invited to participate in the pilot study.

Participant exclusion criteria

Students with previous clinical experience in performing UC

Recruitment start date

01/05/2010

Recruitment end date

01/03/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

Bomhoffs Have 8, 4. tv.
Copenhagen
1872
Denmark

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Faculty of Health and Medical Sciences
Undervisningskvalitetspulje for den kliniske undervisning
3B
Blegdamsvej
Copenhagen
2200
Denmark
-
email@sund.ku.dk

Sponsor type

University/education

Website

http://sund.ku.dk/uddannelse/undervisningskvalitetspulje/

Funders

Funder type

University/education

Funder name

Københavns Universitet

Alternative name(s)

University of Copenhagen, KU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Denmark

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23433258

Publication citations

  1. Results

    Todsen T, Henriksen MV, Kromann CB, Konge L, Eldrup J, Ringsted C, Short- and long-term transfer of urethral catheterization skills from simulation training to performance on patients., BMC Med Educ, 2013, 13, 29, doi: 10.1186/1472-6920-13-29.

Additional files

Editorial Notes