- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03413943
Utilizing Gaze Training to Enhance Laparoscopic Skills Training
Utilizing Gaze Training to Enhance Laparoscopic Technical Skills Training
Studieoversikt
Detaljert beskrivelse
Developing expert performance requires assessment of the thought processes underlying performance and continued refinement of skills in order to obtain automaticity and intuition. Therefore, developing expert surgical skill is a process likely to take longer than the length of residency, thereby diminishing the quality of care delivered to patients.
The proposed study will implement novel neuroscience technique of gaze training to determine if it has the capacity to accelerate technical surgical skill learning in order to achieve competency and expertise in an earlier timeframe. Studies of skill performance have demonstrated that eye movement patterns can be optimized to improve subsequent motor movements. Therefore, gaze training encourages novices to adopt the more efficient gaze patterns of experts while performing a specific task such as laparoscopic surgery. This technique has been applied in the training of surgical residents in a limited capacity making this project an innovative approach to enhance skill development.
Experiment 2: Determine if gaze training can accelerate the learning of laparoscopic skills.
In this experiment the investigators will first establish expert gaze patterns in the Fundamentals of Laparoscopic Surgery modules 1 and 5 by testing a total of 9 participants, including attending surgeons, senior residents, and novices trained to proficiency. The investigators will then compare behavioral learning curves from non-expert participants without gaze training against those trained using both explicit (by reviewing the expert gaze pattern) and implicit gaze (by using a visual mask during the training, leading the participant to follow the expert gaze) derived from the expert gaze patterns. This will be tested in 3 groups of 20 participants, who train for 40-minutes in each of 6 sessions that occur within 3 weeks.
The investigators hypothesize that both explicit and implicit gaze training will lead to faster skill acquisition, with implicit greater than explicit and measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without any gaze training.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age >18 years
- Healthy male and female
- Willing and able to provide informed consent
- Able to follow study procedures
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: explicit gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
|
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Andre navn:
|
Eksperimentell: implicit gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
|
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Andre navn:
|
Sham-komparator: sham gaze training
This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit).
|
Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to completion
Tidsramme: Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.
|
Completion time for each repetition of FLS task 1
|
Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of tasks completed
Tidsramme: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
|
The number of times each FLS task 1 is completed during each training session.
|
This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
|
Number of errors
Tidsramme: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
|
The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition.
|
This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Morgan L Cox, MD, Duke University
- Hovedetterforsker: Greg Appelbaum, PhD, Duke University
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
- Pro00078782_1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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. .
Kliniske studier på Friske Frivillige
-
Universidade do PortoFundação para a Ciência e a TecnologiaRekrutteringHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
Universidad Católica del MauleFullført
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of LeicesterNational Institute for Health Research, United KingdomFullførtPasienter med hjertesvikt og bevart ejeksjonsfraksjon - HFpEF | Pasienter med hjertesvikt med redusert ejeksjonsfraksjon - HFrEF | Healthy Controls Group - alders- og kjønnsmatchet
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvsluttetParkinsons sykdom | Healthy Controls Group - alders- og kjønnsmatchetFrankrike
Kliniske studier på gaze training
-
Florida State UniversityRekruttering
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health...Fullført
-
University of MagdeburgFullførtHjerneskader, traumatiske | HemianopiTyskland
-
University of KentuckyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbeidspartnereRekrutteringDiabetes mellitus, type 2Forente stater
-
Stony Brook UniversityNorthwell Health; Department of Health and Human Services; Rutgers UniversityFullført
-
University College, LondonFullført
-
Tufts UniversityFullført
-
Copka SonpashanHar ikke rekruttert ennå
-
Dana-Farber Cancer InstituteProstate Cancer FoundationRekrutteringPROSTATAKREFT | Metastatisk prostatakreft | Metastatisk prostatakarsinomForente stater
-
Uşak UniversityFullførtLivskvalitet | Overholdelse av behandlingTyrkia