Differences in OSATS ScoresNCT01184950
Virtual Reality Laparoscopy Training
A study testing Trainer Curriculum in people with Differences in OSATS Scores, run by TriHealth Inc. at 1 site in United States.
Trial summary
The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differences in OSATS Scores
- What is being tested?
- Trainer Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Child, Adult, Older adult
Who may be able to join
- Resident in OB/Gyn at TriHealth
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of Virtual Reality Simulator Training in an Obstetrics and Gynecology Residency
The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.
- Conditions
- Differences in OSATS Scores
- Being tested
- Trainer Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trainer CurriculumOther
| Study group | Role | What they receive |
|---|---|---|
| Trainer Curriculum | Experimental | Not described Receives: Other: Trainer Curriculum |
| No Curriculum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
observed structured assessment of technical skills (OSATS) Score
The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded upon entry into the study, after randomization to intervention or no intervention.
Measured: 0 Months
Secondary outcomes (1)
observed structured assessment of technical skills (OSATS) score
The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded 4 months after entry into the study.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differences in OSATS ScoresStudies 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
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184950
- Sponsor's protocol ID
- 10019
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Virtual Reality Simulator Training in an Obstetrics and Gynecology Residency
- ClinicalTrials.gov ID
- NCT01184950
- Acronym / sponsor ID
- 10019
- Conditions
- Differences in OSATS Scores
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- TriHealth Inc.University, hospital or other
- First posted
- 19 Aug 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.
The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.
Study design
- Primary purpose
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainer Curriculum | Experimental | Other: Trainer Curriculum |
| No Curriculum | No intervention | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident in OB/Gyn at TriHealth
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Trainer Curriculum | Other | Trainer Curriculum |
Primary outcome
observed structured assessment of technical skills (OSATS) Score
Time frame: 0 Months
The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded upon entry into the study, after randomization to intervention or no intervention.
1 secondary outcome
observed structured assessment of technical skills (OSATS) score
Time frame: 4 Months
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 9 Nov 2022.
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 Trainer Curriculum in people with Differences in OSATS Scores, run by TriHealth Inc. 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 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 9 Nov 2022. 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. 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?
observed structured assessment of technical skills (OSATS) Score (time frame: 0 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 9 Nov 2022.