Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01137305
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2010-06-02
Brief Title:
Soft Skills and Surgical Performance
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSPSP
Brief 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 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
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 160 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 0050 two-tailed
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 160 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 0050 two-tailed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None