Clinical trial NCT02411747: Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
Official title: Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: Medical
Urology
Randomized Controlled Trial
Endoscopy
Cystoscopy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Directed self-regulated simulation training (DSR) is a validated method in simulation training. The power of testing in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices started by training in a directed self-regulated simulation training environment and informed them that they would be tested by a medical expert afterwards. The intervention group novices were given only written theoretical information and anatomical pictures. The control group were first given a classical oral theoretical introduction by a medical expert and secondly did DSR training. We tested the outcome of the intervention by a validated rating scale for flexible cystoscopy. The novices in both the control and intervention group were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.

The main hypothesis was that testing in relation to DSR would result in higher scores on a validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist in Urology compared to a group having a oral lecture before DSR.


Eligibility criteria: Inclusion Criteria:

* Senior medical students
* Novices in endoscopic procedures
* Written and oral consent

Exclusion Criteria:

* Performed a endoscopic procedure independently
* Lack of language skills
* Lack of written and oral consent

Primary outcomes:
measure: Global Rating Scale
timeFrame: Two to four weeks after day of simulation training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Sarah H. Bube, Cand.med.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
citation: Persoon MC, Schout BM, Muijtjens AM, Hendrikx AJ, Witjes JA, Scherpbier AJ. The effect of a low-fidelity model on cystoscopic skill training: a single-blinded randomized controlled trial. Simul Healthc. 2010 Aug;5(4):213-8. doi: 10.1097/SIH.0b013e3181e1b73d.
citation: Bube S, Dagnaes-Hansen J, Mahmood O, Rohrsted M, Bjerrum F, Salling L, Hansen RB, Konge L. Simulation-based training for flexible cystoscopy - A randomized trial comparing two approaches. Heliyon. 2020 Jan 3;6(1):e03086. doi: 10.1016/j.heliyon.2019.e03086. eCollection 2020 Jan.