Virtual RealityOSATURBNCT03864302
Simulation in Transurethral Bladder Cancer Surgery
A study testing Motor Imagery in people with Virtual Reality and Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Bladder cancer (BC) is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in Danish men with an incidence of more than 2000 and a prevalence of 650 per 100000 citizens. BC have a poor prognosis even when treated radically with cystectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Education, Bladder Cancer
- What is being tested?
- Motor Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Doctors
- Informed written consent.
- Four video-recordings of TURBs.
Who cannot join
- Not providing four video recordings of TURB procedures
- Simulation-based training course in TURB within 6 months
- No consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Urology Department Zealand University Hospital
Roskilde, Danmark, 4000
About this study
Official title: Effect of Motor-imagery in Simulator-based Training in Transurethral Resection of Bladder Tumors - a Randomized Trial
Bladder cancer (BC) is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in Danish men with an incidence of more than 2000 and a prevalence of 650 per 100000 citizens.
BC have a poor prognosis even when treated radically with cystectomy. The 5-year survival rate after radical cystectomy for T2 muscle-invasive tumors are 23-60 % and decreasing further to 23 % for T4 muscle-invasive tumors. BC is highly recurrent with an overall recurrence of 50 %.
Read more
BC is considered to be the number one cost-expensive malignant disease of all malignant diseases measured by lifetime per patient in the United States.
The degree of muscle invasion in the bladder is histologically and clinically defined by a transurethral resection of the bladder tumor (TUR-B). The tumor is resected radically if possible.
Thus, it is of absolute importance that a sufficient TURB is performed, since a resection to the muscle layer of the bladder wall, the detrusor, is of prognostic value for the patient.
Problem: The quality of the surgery is depending on the surgeon A recent international meta-analysis shows that up to 78% of the tumors are not radically resected. When these tumors are resected in a second TURB 24-28% of the tumors are found to be muscle-invasive.
Furter, there is evidence indicating that the outcome of the resection is dependent on surgeon experience.
Large multi-centre retrospective studies have showed that resident-involvement in TURB results in less radical bladder tumor resections and result in higher recurrence rates of bladder tumors and high numbers of re-admission after TURB.
In Denmark, the current surgical curriculum states that TURB is a learning goal in the first year of the training. The formal training in TURB in Denmark is traditional apprenticeship in accordance with the Halstedian principle "see one, do one, teach one". No validated simulator-based certification in TURB exits today in Denmark or internationally.
Purpose: Start from the beginning - improve the training of the surgeons Simulator-based training in surgical procedures is an effective method to gain surgical skills in a large spectrum of surgical procedures. In the initial phase of the learning curve it has even proven more effective than traditional apprenticeship and thus both the World Health Organization (WHO) and the European Association of Urology (EAU) calls for implementation of simulation training programmes in medical surgical education.
The aim of this project is to validate and develop a simulator-based urological training programme in TURB, to implement the programme nationally and internationally, and hereby improve the outcomes in the surgical treatment of patients with bladder cancer.
Read the detailed description
Doctors' surgical skills have consequences for patients outcomes and continued training and assessment of surgeons has the potential to improve patient safety and shorten learning curves in the operation room.
Traditionally, surgeons have acquired their skills by observation, supervision and direction of masters in the field. Such education is indispensable. Only, with the increasing demands on production, patient safety issues and decreasing working hours a need for alternatives to the classical surgical training has awoken.
Simulated surgeries make it possible to repeat and perfect performances until reaching a proficient level. Virtual reality (VR) simulators can provide continuously automated feedback while the doctor is performing the procedure and thus direct the training.
Thus, in the last decades simulators for surgical skills training have gained increasing popularity. Simulation training has been found efficient in skills acquisition in a variety of surgical procedures.Simulators allow repeating training until reaching a proficiency level in the skill. Ultimately, the doctor reaches a minimum competent skill acquisition in the procedure prior to advancing to surgeries on patients.
Mastery Learning (ML) is a strict proficiency training concept, in which the learner trains until reaching a minimum acquisition level. The endpoint of the training is hereby a predefined competency level, and not an arbitrary amount of training hours. Hence, ML ensures a minimum skill acquisition level.
In the initial learning phase of the learning curve the use of ML simulation training has been proven superior to traditional apprenticeship.
To identify proficiency, assessments are needed. The assessments should be based on solid evidence of validity. The development and validation of tests are essential in a proficiency-based curriculum.
Constructing a training curriculum in surgery should be based on a defined framework. Zevin et al. proposed a training-design framework composed of three steps: cognitive knowledge (conceptualization, visualization and verbalization), psychomotor skills training (deliberate and distributed self-regulated training to a targeted proficiency-level, with continuing feedback and maintenance) and non-technical skills (communication, collaboration, professionalism and management). Thomas et al. proposed a six-step approach for curriculum development including problem identification, need assessment, goal setting and teaching objectives, educational strategies, implementation and evaluation and feedback.
A needs assessment analysis among residents and urologists in Denmark from 2017 confirms the feasibility and necessity of comprehensive ex-vivo simulation-based curriculum in TUR-B. TUR-B simulators have been available for a decade but some have proven insufficiency, others promising, but there is a need for creation of evidence-based simulator training programs and development of valid assessments tool to evaluate the performances.
The effect on training of a novel curriculum can be explored and evaluated using a framework such as Kirkpatrick's model for evaluation of training effect on skills, transfer from simulation to workplace, benefits for patients, and finally economics and return of investments.
This trial aims to develop an evidence-based TURB training and certification program including an assessment tool for clinical procedures (trial 1.1), learning curve study (trial 1.2) and pre- and post-training study and effects on operation room TURB performance (trial 1.3) and explore the prognostic clinical value of performance on simulation-based test (trial 1.4).
- Conditions
- Virtual Reality, Education, Bladder Cancer
- Being tested
- Motor Imagery
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ImageryBehavioural
Motor imagery (MI) is a psychological technique for improvement of motor skills.(24) MI skill training (MIST) has been used and explored in several disciplines including Sports, Music, Education, Psychology and Medicine.(18) The literature has found positive effects on performances in professional athletes but also on rehabilitation of stroke patients.(25,26) MI is a cognitive imagery of a physical performance, e.g. a high jumper imagine a high jump, prior to performance. MI is not as effective as physical practice, but more effective compared to no training.(27) Further, MI combined with physical practice has been found to be more effective in skill performance in sports compared to physical practice alone.(18) MIST has shown promising results on surgical performances in flexible cystoscopy performed by doctors.(28)
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery | Experimental | The intervention group is informed about the concept of motor imagery (MI) for performance enhancement and are instructed in using the modified PETTLEP framework for TURB (table 1).(18) The intervention group performs a MI training session (MITS) prior to each VR simulation procedure.
Table 1: PEELP framework:
Physical: Sitting in front of the simulator, aloud to touch and move the scope Environment: Simulated sounds from the OR, including electrical device feedback from devices and vital measures Task: Four standardized TURB cases Timing: Each MI session is temporal to a simulated TURB case, max. 10 minutes Learning: Think aloud the major steps of the procedure using Emotions: Imagine the emotions when the surgery progresses and when an adverse event occurs Perspectives: Internal perspective thinking "then I…" Receives: Behavioral: Motor Imagery |
| Control | No intervention | The control group proceeds directly to standard VR-simulator training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSATURB total score
Assessment tool with nine items, each item i rated on a 5-point Likert scale, minimum of 1, max. 5.
Measured: 8 hours pr. participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jun 2019
- Primary completion30 Mar 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation
- Responsible party
- Principal investigator, Sarah Hjartbro Bube, Zealand University Hospital
- Investigators
- Sarah Bube, MD, Principal investigator, Zeland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864302
- Sponsor's protocol ID
- H-19-1-OSATURB
- Acronym
- OSATURB
- Status last verified
- Aug 2021
- First submitted
- 1 Mar 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625.
PubMed 24106936Bjerrum F, Thomsen ASS, Nayahangan LJ, Konge L. Surgical simulation: Current practices and future perspectives for technical skills training. Med Teach. 2018 Jul;40(7):668-675. doi: 10.1080/0142159X.2018.1472754. Epub 2018 Jun 17.
PubMed 29911477Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
PubMed 21900138McGaghie WC, Issenberg SB, Barsuk JH, Wayne DB. A critical review of simulation-based mastery learning with translational outcomes. Med Educ. 2014 Apr;48(4):375-85. doi: 10.1111/medu.12391.
PubMed 24606621McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.
PubMed 21512370Konge L, Clementsen PF, Ringsted C, Minddal V, Larsen KR, Annema JT. Simulator training for endobronchial ultrasound: a randomised controlled trial. Eur Respir J. 2015 Oct;46(4):1140-9. doi: 10.1183/13993003.02352-2015. Epub 2015 Jul 9.
PubMed 26160875Borgersen NJ, Naur TMH, Sorensen SMD, Bjerrum F, Konge L, Subhi Y, Thomsen ASS. Gathering Validity Evidence for Surgical Simulation: A Systematic Review. Ann Surg. 2018 Jun;267(6):1063-1068. doi: 10.1097/SLA.0000000000002652.
PubMed 29303808Zevin B, Levy JS, Satava RM, Grantcharov TP. A consensus-based framework for design, validation, and implementation of simulation-based training curricula in surgery. J Am Coll Surg. 2012 Oct;215(4):580-586.e3. doi: 10.1016/j.jamcollsurg.2012.05.035. Epub 2012 Jul 3.
PubMed 22762990Nayahangan LJ, Bolling Hansen R, Gilboe Lindorff-Larsen K, Paltved C, Nielsen BU, Konge L. Identifying content for simulation-based curricula in urology: a national needs assessment. Scand J Urol. 2017 Dec;51(6):484-490. doi: 10.1080/21681805.2017.1352618. Epub 2017 Jul 26.
PubMed 28743217Schout BM, Bemelmans BL, Martens EJ, Scherpbier AJ, Hendrikx AJ. How useful and realistic is the uro trainer for training transurethral prostate and bladder tumor resection procedures? J Urol. 2009 Mar;181(3):1297-303; discussion 1303. doi: 10.1016/j.juro.2008.10.169. Epub 2009 Jan 18.
PubMed 19152928de Vries AH, van Genugten HG, Hendrikx AJ, Koldewijn EL, Schout BM, Tjiam IM, van Merrienboer JJ, Muijtjens AM, Wagner C. The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation. J Endourol. 2016 May;30(5):580-7. doi: 10.1089/end.2015.0723. Epub 2016 Jan 22.
PubMed 26671712Cook DA. Twelve tips for evaluating educational programs. Med Teach. 2010;32(4):296-301. doi: 10.3109/01421590903480121.
PubMed 20353325Feldman M, Lazzara EH, Vanderbilt AA, DiazGranados D. Rater training to support high-stakes simulation-based assessments. J Contin Educ Health Prof. 2012 Fall;32(4):279-86. doi: 10.1002/chp.21156.
PubMed 23280532Downing SM, Haladyna TM. Validity threats: overcoming interference with proposed interpretations of assessment data. Med Educ. 2004 Mar;38(3):327-33. doi: 10.1046/j.1365-2923.2004.01777.x.
PubMed 14996342Feltz DL, Landers DM. The Effects of Mental Practice on Motor Skill Learning and Performance: A Meta-analysis. J Sport Psychol. 1983 Mar;5(1):25-57.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor-imagery in Simulator-based Training in Transurethral Resection of Bladder Tumors - a Randomized Trial
- ClinicalTrials.gov ID
- NCT03864302
- Acronym / sponsor ID
- OSATURB / H-19-1-OSATURB
- Conditions
- Virtual Reality, Education, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder cancer (BC) is the seventh most common cancer disease among men worldwide, and the fourth most common cancer in Danish men with an incidence of more than 2000 and a prevalence of 650 per 100000 citizens.
BC have a poor prognosis even when treated radically with cystectomy. The 5-year survival rate after radical cystectomy for T2 muscle-invasive tumors are 23-60 % and decreasing further to 23 % for T4 muscle-invasive tumors. BC is highly recurrent with an overall recurrence of 50 %.
BC is considered to be the number one cost-expensive malignant disease of all malignant diseases measured by lifetime per patient in the United States.
The degree of muscle invasion in the bladder is histologically and clinically defined by a transurethral resection of the bladder tumor (TUR-B). The tumor is resected radically if possible.
Thus, it is of absolute importance that a sufficient TURB is performed, since a resection to the muscle layer of the bladder wall, the detrusor, is of prognostic value for the patient.
Problem: The quality of the surgery is depending on the surgeon A recent international meta-analysis shows that up to 78% of the tumors are not radically resected. When these tumors are resected in a second TURB 24-28% of the tumors are found to be muscle-invasive.
Furter, there is evidence indicating that the outcome of the resection is dependent on surgeon experience.
Large multi-centre retrospective studies have showed that resident-involvement in TURB results in less radical bladder tumor resections and result in higher recurrence rates of bladder tumors and high numbers of re-admission after TURB.
In Denmark, the current surgical curriculum states that TURB is a learning goal in the first year of the training. The formal training in TURB in Denmark is traditional apprenticeship in accordance with the Halstedian principle "see one, do one, teach one". No validated simulator-based certification in TURB exits today in Denmark or internationally.
Purpose: Start from the beginning - improve the training of the surgeons Simulator-based training in surgical procedures is an effective method to gain surgical skills in a large spectrum of surgical procedures. In the initial phase of the learning curve it has even proven more effective than traditional apprenticeship and thus both the World Health Organization (WHO) and the European Association of Urology (EAU) calls for implementation of simulation training programmes in medical surgical education.
The aim of this project is to validate and develop a simulator-based urological training programme in TURB, to implement the programme nationally and internationally, and hereby improve the outcomes in the surgical treatment of patients with bladder cancer.
Detailed description
Doctors' surgical skills have consequences for patients outcomes and continued training and assessment of surgeons has the potential to improve patient safety and shorten learning curves in the operation room.
Traditionally, surgeons have acquired their skills by observation, supervision and direction of masters in the field. Such education is indispensable. Only, with the increasing demands on production, patient safety issues and decreasing working hours a need for alternatives to the classical surgical training has awoken.
Simulated surgeries make it possible to repeat and perfect performances until reaching a proficient level. Virtual reality (VR) simulators can provide continuously automated feedback while the doctor is performing the procedure and thus direct the training.
Thus, in the last decades simulators for surgical skills training have gained increasing popularity. Simulation training has been found efficient in skills acquisition in a variety of surgical procedures.Simulators allow repeating training until reaching a proficiency level in the skill. Ultimately, the doctor reaches a minimum competent skill acquisition in the procedure prior to advancing to surgeries on patients.
Mastery Learning (ML) is a strict proficiency training concept, in which the learner trains until reaching a minimum acquisition level. The endpoint of the training is hereby a predefined competency level, and not an arbitrary amount of training hours. Hence, ML ensures a minimum skill acquisition level.
In the initial learning phase of the learning curve the use of ML simulation training has been proven superior to traditional apprenticeship.
To identify proficiency, assessments are needed. The assessments should be based on solid evidence of validity. The development and validation of tests are essential in a proficiency-based curriculum.
Constructing a training curriculum in surgery should be based on a defined framework. Zevin et al. proposed a training-design framework composed of three steps: cognitive knowledge (conceptualization, visualization and verbalization), psychomotor skills training (deliberate and distributed self-regulated training to a targeted proficiency-level, with continuing feedback and maintenance) and non-technical skills (communication, collaboration, professionalism and management). Thomas et al. proposed a six-step approach for curriculum development including problem identification, need assessment, goal setting and teaching objectives, educational strategies, implementation and evaluation and feedback.
A needs assessment analysis among residents and urologists in Denmark from 2017 confirms the feasibility and necessity of comprehensive ex-vivo simulation-based curriculum in TUR-B. TUR-B simulators have been available for a decade but some have proven insufficiency, others promising, but there is a need for creation of evidence-based simulator training programs and development of valid assessments tool to evaluate the performances.
The effect on training of a novel curriculum can be explored and evaluated using a framework such as Kirkpatrick's model for evaluation of training effect on skills, transfer from simulation to workplace, benefits for patients, and finally economics and return of investments.
This trial aims to develop an evidence-based TURB training and certification program including an assessment tool for clinical procedures (trial 1.1), learning curve study (trial 1.2) and pre- and post-training study and effects on operation room TURB performance (trial 1.3) and explore the prognostic clinical value of performance on simulation-based test (trial 1.4).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery | Experimental | Behavioral: Motor ImageryThe intervention group is informed about the concept of motor imagery (MI) for performance enhancement and are instructed in using the modified PETTLEP framework for TURB (table 1).(18) The intervention group performs a MI training session (MITS) prior to each VR simulation procedure. Table 1: PEELP framework: Physical: Sitting in front of the simulator, aloud to touch and move the scope Environment: Simulated sounds from the OR, including electrical device feedback from devices and vital measures Task: Four standardized TURB cases Timing: Each MI session is temporal to a simulated TURB case, max. 10 minutes Learning: Think aloud the major steps of the procedure using Emotions: Imagine the emotions when the surgery progresses and when an adverse event occurs Perspectives: Internal perspective thinking "then I…" |
| Control | No intervention | –The control group proceeds directly to standard VR-simulator training. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Doctors
- Informed written consent.
- Four video-recordings of TURBs.
Key exclusion criteria (3 listed)
- Not providing four video recordings of TURB procedures
- Simulation-based training course in TURB within 6 months
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor ImageryMotor imagery (MI) is a psychological technique for improvement of motor skills.(24) MI skill training (MIST) has been used and explored in several disciplines including Sports, Music, Education, Psychology and Medicine.(18) The literature has found positive effects on performances in professional athletes but also on rehabilitation of stroke patients.(25,26) MI is a cognitive imagery of a physical performance, e.g. a high jumper imagine a high jump, prior to performance. MI is not as effective as physical practice, but more effective compared to no training.(27) Further, MI combined with physical practice has been found to be more effective in skill performance in sports compared to physical practice alone.(18) MIST has shown promising results on surgical performances in flexible cystoscopy performed by doctors.(28) | Behavioural | Motor Imagery |
Primary outcome
OSATURB total score
Time frame: 8 hours pr. participant
Assessment tool with nine items, each item i rated on a 5-point Likert scale, minimum of 1, max. 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 24106936Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625.
- Background: PubMed 29911477Bjerrum F, Thomsen ASS, Nayahangan LJ, Konge L. Surgical simulation: Current practices and future perspectives for technical skills training. Med Teach. 2018 Jul;40(7):668-675. doi: 10.1080/0142159X.2018.1472754. Epub 2018 Jun 17.
- Background: PubMed 21900138Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
- Background: PubMed 24606621McGaghie WC, Issenberg SB, Barsuk JH, Wayne DB. A critical review of simulation-based mastery learning with translational outcomes. Med Educ. 2014 Apr;48(4):375-85. doi: 10.1111/medu.12391.
- Background: PubMed 21512370McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.
- Background: PubMed 26160875Konge L, Clementsen PF, Ringsted C, Minddal V, Larsen KR, Annema JT. Simulator training for endobronchial ultrasound: a randomised controlled trial. Eur Respir J. 2015 Oct;46(4):1140-9. doi: 10.1183/13993003.02352-2015. Epub 2015 Jul 9.
- Background: PubMed 29303808Borgersen NJ, Naur TMH, Sorensen SMD, Bjerrum F, Konge L, Subhi Y, Thomsen ASS. Gathering Validity Evidence for Surgical Simulation: A Systematic Review. Ann Surg. 2018 Jun;267(6):1063-1068. doi: 10.1097/SLA.0000000000002652.
- Background: PubMed 22762990Zevin B, Levy JS, Satava RM, Grantcharov TP. A consensus-based framework for design, validation, and implementation of simulation-based training curricula in surgery. J Am Coll Surg. 2012 Oct;215(4):580-586.e3. doi: 10.1016/j.jamcollsurg.2012.05.035. Epub 2012 Jul 3.
- Background: PubMed 28743217Nayahangan LJ, Bolling Hansen R, Gilboe Lindorff-Larsen K, Paltved C, Nielsen BU, Konge L. Identifying content for simulation-based curricula in urology: a national needs assessment. Scand J Urol. 2017 Dec;51(6):484-490. doi: 10.1080/21681805.2017.1352618. Epub 2017 Jul 26.
- Background: PubMed 19152928Schout BM, Bemelmans BL, Martens EJ, Scherpbier AJ, Hendrikx AJ. How useful and realistic is the uro trainer for training transurethral prostate and bladder tumor resection procedures? J Urol. 2009 Mar;181(3):1297-303; discussion 1303. doi: 10.1016/j.juro.2008.10.169. Epub 2009 Jan 18.
- Background: PubMed 26671712de Vries AH, van Genugten HG, Hendrikx AJ, Koldewijn EL, Schout BM, Tjiam IM, van Merrienboer JJ, Muijtjens AM, Wagner C. The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation. J Endourol. 2016 May;30(5):580-7. doi: 10.1089/end.2015.0723. Epub 2016 Jan 22.
- Background: PubMed 20353325Cook DA. Twelve tips for evaluating educational programs. Med Teach. 2010;32(4):296-301. doi: 10.3109/01421590903480121.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Bube, MD principal investigator
Zeland Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery in people with Virtual Reality and Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSATURB total score (time frame: 8 hours pr. participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864302, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.