Healthy VolunteersNCT03413943
Utilizing Gaze Training to Enhance Laparoscopic Skills Training
A study testing gaze training in people with Healthy Volunteers, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the influences of gaze training (GT) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of GT in the second of 2 experiments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- gaze training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 13 Mar 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Healthy male and female
- Willing and able to provide informed consent
- Able to follow study procedures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Utilizing Gaze Training to Enhance Laparoscopic Technical Skills Training
The purpose of this study is to test the influences of gaze training (GT) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of GT in the second of 2 experiments. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- gaze training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaze trainingOther
Also called Argus Science
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.
| Study group | Role | What they receive |
|---|---|---|
| explicit gaze training | Experimental | This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). Receives: Other: gaze training |
| implicit gaze training | Experimental | This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). Receives: Other: gaze training |
| sham gaze training | Sham comparator | This is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). Receives: Other: gaze training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion
Completion time for each repetition of FLS task 1
Measured: Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.
Secondary outcomes (2)
Number of tasks completed
The number of times each FLS task 1 is completed during each training session.
Measured: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
Number of errors
The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition.
Measured: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Jan 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model description
- After identification of the expert gaze, subjects will be randomized into explicit or implicit gaze training techniques.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan L Cox, MD, Principal investigator, Duke UniversityGreg Appelbaum, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413943
- Sponsor's protocol ID
- Pro00078782_1
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2018
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Gaze Training to Enhance Laparoscopic Technical Skills Training
- ClinicalTrials.gov ID
- NCT03413943
- Acronym / sponsor ID
- Pro00078782_1
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 29 Jan 2018 (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.
The purpose of this study is to test the influences of gaze training (GT) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of GT in the second of 2 experiments. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- After identification of the expert gaze, subjects will be randomized into explicit or implicit gaze training techniques.
| Arm | Type | Receives |
|---|---|---|
| explicit gaze training | Experimental | Other: gaze trainingThis is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). |
| implicit gaze training | Experimental | Other: gaze trainingThis is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). |
| sham gaze training | Sham comparator | Other: gaze trainingThis is an arm of the second phase of the study utilizing gaze training in two different teaching techniques (explicit vs implicit). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Healthy male and female
- Willing and able to provide informed consent
- Able to follow study procedures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gaze trainingAlso: Argus ScienceGaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern. | Other | explicit gaze training, implicit gaze training, sham gaze training |
Primary outcome
Time to completion
Time frame: 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
2 secondary outcomes
Number of tasks completed
Time frame: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
Number of errors
Time frame: This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period.
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 12 Jan 2021.
- Study ResultsLink provided by the sponsor.
- 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.
Morgan L Cox, MD principal investigator
Duke University
Greg Appelbaum, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaze training in people with Healthy Volunteers, run by Duke University at 1 site in United States.
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 4 inclusion and 0 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 12 Jan 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 United States. 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. Some participants in this study may receive a placebo. 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?
Time to completion (time frame: Collected for pre- and post-tests performed prior to and after the 6 separate training sessions within 7-days.). 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 12 Jan 2021.