Skilss Acquisition for Virtual Reality Laparoscopic TrainingNCT05731674
Varied Practice on LAPSIM
A study testing Random selection of excercises in people with Skilss Acquisition for Virtual Reality Laparoscopic Training, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial summary
To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Skilss Acquisition for Virtual Reality Laparoscopic Training
- What is being tested?
- Random selection of excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2022to 1 Jan 2023
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical Students enrolled at a Danish University
Who cannot join
- Not being enrolled at a medical program at a Danish University, having participated in other virtual reality studies regarding laparoscopy, have had training or practice in laparoscopy on either pigs or in the clinic, have any medical conditions that may hinder a standard learning process when it comes to skills acquisition (eg. parkinson's disease, limited eye-sight etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Random Selection of Exercises Versus Self-Directed Training, for Laparoscopic Simulator Training - a Randomized Trial
To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training.
- Being tested
- Random selection of excercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random selection of excercisesOther
Participants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Other: Random selection of excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (minutes) to reach the predefined proficiency settings for the basic skills and the procedural module after 3-6 weeks without laparoscopic training.
Measured: 6 weeks
Secondary outcomes (2)
Time (minutes) to reach the predefined proficiency settings for the basic skills
To examine any difference in training time for the two groups over-all
Measured: 6 weeks
Time (minutes) to reach proficiency setting for the procedural module (salpingectomy due to an ectopic bleeding)
To examine if there is any difference in training time (minutes) for the two-groups when practicing on the procedural module (salpingectomy due to an ectopic bleeding)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Sep 2022
- Primary completion15 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skilss Acquisition for Virtual Reality Laparoscopic TrainingStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anishan Vamadevan, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731674
- Sponsor's protocol ID
- Varied Practice's on LAPSIM
- Status last verified
- Feb 2023
- First submitted
- 30 Jun 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Selection of Exercises Versus Self-Directed Training, for Laparoscopic Simulator Training - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05731674
- Acronym / sponsor ID
- Varied Practice's on LAPSIM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Feb 2023 (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.
To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: Random selection of excercises |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical Students enrolled at a Danish University
Key exclusion criteria (1 listed)
- Not being enrolled at a medical program at a Danish University, having participated in other virtual reality studies regarding laparoscopy, have had training or practice in laparoscopy on either pigs or in the clinic, have any medical conditions that may hinder a standard learning process when it comes to skills acquisition (eg. parkinson's disease, limited eye-sight etc).
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 |
|---|---|---|
| Random selection of excercisesParticipants in the intervention group will train using a random selection of excercises and complete the profiency-based traning program. | Other | Intervention |
Primary outcome
Time (minutes) to reach the predefined proficiency settings for the basic skills and the procedural module after 3-6 weeks without laparoscopic training.
Time frame: 6 weeks
2 secondary outcomes
Time (minutes) to reach the predefined proficiency settings for the basic skills
Time frame: 6 weeks
Time (minutes) to reach proficiency setting for the procedural module (salpingectomy due to an ectopic bleeding)
Time frame: 6 weeks
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 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Random selection of excercises in people with Skilss Acquisition for Virtual Reality Laparoscopic Training, run by Copenhagen Academy for Medical Education and Simulation 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 1 inclusion and 1 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 16 Feb 2023. 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?
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 (minutes) to reach the predefined proficiency settings for the basic skills and the procedural module after 3-6 weeks without laparoscopic training. (time frame: 6 weeks). 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 16 Feb 2023.