Delivery of Health CareSSPSPNCT01137305
Soft Skills and Surgical Performance
A study testing VR- training in people with Delivery of Health Care, run by Philipps University Marburg.
Trial summary
Background and hypothesis: Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delivery of Health Care
- What is being tested?
- VR- training
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- surgical residency not exceeding the first year of surgical training
- limited experience in MIS (camera navigation in laparoscopic cholecystectomies only)
- informed consent to study procedures and publication of anonymized data
Who cannot join
- surgical residency exceeding the first year of surgical training
- experience in MIS exceeding camera navigation in laparoscopic cholecystectomies
- lack of informed consent
About this study
Official title: Do Soft Skills Predict Surgical Performance? Do Soft Skills Predict Surgical Performance? A Prospective Randomized Controlled Single Center Educational Trial Evaluating Predictors of Skill Acquisition in Virtual Reality Laparoscopy
Background and hypothesis:
Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Thus to hypothesize soft skills predicting surgical performance in a VR- setting.
Method:
A prospective randomized controlled single center educational trial was carried out to evaluate the impact of structured VR- training and defined soft skills such as self- efficacy, stress- coping and motivation on VR- performance.
Read the detailed description
Method:
Eligibility criteria were surgical residency not exceeding the first year of surgical training, a limited experience in MIS and informed consent to the study procedures including an anonymized publication of the study data. Limited experience in MIS was defined as camera navigation in laparoscopic cholecystectomies only.
Fifty residents were enrolled and prospectively randomized to either three months of structured VR- training or no training. Every participant underwent a basic VR- skills assessment and a serial assessment of defined soft skills including self- efficacy, stress- coping and motivation prior to randomization.
Basic VR- skills were measured within seven modules of the VR- simulator LapSim® (Surgical Science, Goteborg, Sweden) including "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting". Each module had to be performed in two levels of difficulty- medium and hard. Means of defined parameters of VR- performance were generated. Defined parameters of VR- performance comprised "time to complete task", "economy of instrument motion" and "tissue damage".
Serial assessment of defined soft skills comprised standardized psychological paper- pencil questionnaires regarding self efficacy (GSE), stress coping (SVF 78) and motivation (QCM).
Participants randomized to the intervention group had to pass sessions of 45 minutes each twice a week for three months. Participants randomized to the control group underwent no training at all.
Three months after randomization, VR- performance was assessed likewise. Outcome measurement of VR- performance defined results derived from the most complex module "diathermy- cutting" as endpoint.
The study was approved by the local ethics committee. Participation of the study was voluntary. Data were blinded to the investigators.
The data were descriptively analysed using SPSS® software version 16.0 (SSPS®, Chicago, Illinois, USA). Spearman regression analysis was performed to correlate means of virtual laparoscopic performance and the results derived from serial psychological testing. The differences between the randomized groups were assessed by means of the non- parametric Mann-Whitney- Test regarding all parameters, laparoscopic performance as well psychological scores. Relation of means was carried out using the two- independent t- Test. The level of statistical significance was set at p < 0.050 (two-tailed).
- Conditions
- Delivery of Health Care
- Being tested
- VR- training
- Keywords
- Virtual reality, surgical training, Health Care [N]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR- trainingOther
Also called Educational trial within surgical trainees
Prospective randomization if 50 subjects to either three months of structured VR- training or no training; basic VR- skills assessment and a serial assessment of defined soft skills: self- efficacy, stress- coping and motivation prior to randomization; basic VR- skills measured within seven modules of the VR- simulator LapSim®: "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting" in different levels of difficulty- medium and hard referring to "time to complete task", "economy of instrument motion" and "tissue damage"; intervention group: sessions of 45 minutes each twice a week for three months; control group: no training
What is being measured
The primary outcome is the main question the study is designed to answer.
VR- performance after training
Outcome measurement comprised defined parameters of VR- performance including "time to complete task", economy of instrument motion" and "tissue damage" within the most complex module "diathermy cutting" as primary endpoint.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery of Health CareStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Investigators
- Iyad Hassan, MD, Principal investigator, Department of Visceral-, Thoracic- and Vascular Surgery, Philipps- University Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137305
- Sponsor's protocol ID
- Katja Maschuw, MD
- Acronym
- SSPSP
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Soft Skills Predict Surgical Performance? Do Soft Skills Predict Surgical Performance? A Prospective Randomized Controlled Single Center Educational Trial Evaluating Predictors of Skill Acquisition in Virtual Reality Laparoscopy
- ClinicalTrials.gov ID
- NCT01137305
- Acronym / sponsor ID
- SSPSP / Katja Maschuw, MD
- Conditions
- Delivery of Health Care
- Keywords
- Virtual reality, surgical training, Health Care [N]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Jun 2010 (estimated)
- 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.
Background and hypothesis:
Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Thus to hypothesize soft skills predicting surgical performance in a VR- setting.
Method:
A prospective randomized controlled single center educational trial was carried out to evaluate the impact of structured VR- training and defined soft skills such as self- efficacy, stress- coping and motivation on VR- performance.
Detailed description
Method:
Eligibility criteria were surgical residency not exceeding the first year of surgical training, a limited experience in MIS and informed consent to the study procedures including an anonymized publication of the study data. Limited experience in MIS was defined as camera navigation in laparoscopic cholecystectomies only.
Fifty residents were enrolled and prospectively randomized to either three months of structured VR- training or no training. Every participant underwent a basic VR- skills assessment and a serial assessment of defined soft skills including self- efficacy, stress- coping and motivation prior to randomization.
Basic VR- skills were measured within seven modules of the VR- simulator LapSim® (Surgical Science, Goteborg, Sweden) including "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting". Each module had to be performed in two levels of difficulty- medium and hard. Means of defined parameters of VR- performance were generated. Defined parameters of VR- performance comprised "time to complete task", "economy of instrument motion" and "tissue damage".
Serial assessment of defined soft skills comprised standardized psychological paper- pencil questionnaires regarding self efficacy (GSE), stress coping (SVF 78) and motivation (QCM).
Participants randomized to the intervention group had to pass sessions of 45 minutes each twice a week for three months. Participants randomized to the control group underwent no training at all.
Three months after randomization, VR- performance was assessed likewise. Outcome measurement of VR- performance defined results derived from the most complex module "diathermy- cutting" as endpoint.
The study was approved by the local ethics committee. Participation of the study was voluntary. Data were blinded to the investigators.
The data were descriptively analysed using SPSS® software version 16.0 (SSPS®, Chicago, Illinois, USA). Spearman regression analysis was performed to correlate means of virtual laparoscopic performance and the results derived from serial psychological testing. The differences between the randomized groups were assessed by means of the non- parametric Mann-Whitney- Test regarding all parameters, laparoscopic performance as well psychological scores. Relation of means was carried out using the two- independent t- Test. The level of statistical significance was set at p < 0.050 (two-tailed).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- surgical residency not exceeding the first year of surgical training
- limited experience in MIS (camera navigation in laparoscopic cholecystectomies only)
- informed consent to study procedures and publication of anonymized data
Key exclusion criteria (3 listed)
- surgical residency exceeding the first year of surgical training
- experience in MIS exceeding camera navigation in laparoscopic cholecystectomies
- lack of informed 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 |
|---|---|---|
| VR- trainingAlso: Educational trial within surgical traineesProspective randomization if 50 subjects to either three months of structured VR- training or no training; basic VR- skills assessment and a serial assessment of defined soft skills: self- efficacy, stress- coping and motivation prior to randomization; basic VR- skills measured within seven modules of the VR- simulator LapSim®: "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting" in different levels of difficulty- medium and hard referring to "time to complete task", "economy of instrument motion" and "tissue damage"; intervention group: sessions of 45 minutes each twice a week for three months; control group: no training | Other | – |
Primary outcome
VR- performance after training
Time frame: Three months
Outcome measurement comprised defined parameters of VR- performance including "time to complete task", economy of instrument motion" and "tissue damage" within the most complex module "diathermy cutting" as primary endpoint.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2010.
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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.
Iyad Hassan, MD principal investigator
Department of Visceral-, Thoracic- and Vascular Surgery, Philipps- University Marburg, Germany
Questions about this trial
What is this clinical trial studying?
A study testing VR- training in people with Delivery of Health Care, run by Philipps University Marburg.
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: finished, as of the sponsor's last update on 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VR- performance after training (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2010.