Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Testing+endoscopic simulation training
Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max.
time cap 1h45min.
15 minutes of testing with a expert in the procedure.
Total max time: 2 hours.
|
|
|
Aktiv komparator: Oral lecture+endoscopic simulation training
Endoscopic training in flexible cystoscopy by directed self-regulated training, max.
time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure.
Total max.
time: 2 hours.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Global Rating Scale
Tidsramme: Two to four weeks after day of simulation training
|
The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale.
A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures.
GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure.
Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25.
At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.
|
Two to four weeks after day of simulation training
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sarah H. Bube, Cand.med., Rigshospitalet, Denmark
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Kromann CB, Jensen ML, Ringsted C. The effect of testing on skills learning. Med Educ. 2009 Jan;43(1):21-7. doi: 10.1111/j.1365-2923.2008.03245.x.
- Matsumoto ED, Hamstra SJ, Radomski SB, Cusimano MD. A novel approach to endourological training: training at the Surgical Skills Center. J Urol. 2001 Oct;166(4):1261-6. doi: 10.1016/s0022-5347(05)65749-7.
- Schout BM, Ananias HJ, Bemelmans BL, d'Ancona FC, Muijtjens AM, Dolmans VE, Scherpbier AJ, Hendrikx AJ. Transfer of cysto-urethroscopy skills from a virtual-reality simulator to the operating room: a randomized controlled trial. BJU Int. 2010 Jul;106(2):226-31; discussion 231. doi: 10.1111/j.1464-410X.2009.09049.x. Epub 2009 Nov 12.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- H-4-2014-122
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .