Focus of Study: Simulation TechnologyNCT03894644
Simulation-based Learning for Neurosurgical Instruments in Perioperative Nurses
A study testing Simulation technology in people with Focus of Study: Simulation Technology, run by Nova Scotia Health Authority.
Trial summary
Rapid technological advances in the last 20 years have led to the exponential adoption of simulation-based learning in nursing education. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focus of Study: Simulation Technology
- What is being tested?
- Simulation technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2015to 25 May 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Perioperative nurse
- Employed at Queen Elizabeth II Health Sciences Center
Who cannot join
- -Unable to provide informed consent
About this study
Official title: Knowledge Transfer and Retention of Simulation-based Learning for Neurosurgical Instruments: a Randomized Trial of 100 Perioperative Nurses
Rapid technological advances in the last 20 years have led to the exponential adoption of simulation-based learning in nursing education.
Read the detailed description
Simulation-based learning is designed to engage, challenge and enrich the learner's knowledge base and skill set. It presents the opportunity to experience a variety of clinical scenarios, both common and uncommon, in a safe environment allowing repeated skills training and facilitating the transfer of classroom-knowledge to real situations.Research demonstrates that simulation can improve student engagement and learning and is being increasingly used as an educational strategy for nursing students. This prospective randomized controlled study that was undertaken with the following goals:
- to investigate the effectiveness of simulation-based training in a large sample of perioperative nurses, measured as nurses' learning progress in the simulation environment;
- to determine whether the learning acquired through this training is transferable to recognizing real surgical instruments; and
- to evaluate whether simulation-based learning is retained at least one week.
- Conditions
- Focus of Study: Simulation Technology
- Being tested
- Simulation technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation technologyOther
The intervention involves three consecutive sessions of the PeriopSim™ Instrument Trainer, followed by two consecutive sessions of the PeriopSim™ for Burr Hole Surgery (https://periopsim.com).
| Study group | Role | What they receive |
|---|---|---|
| Group A: simulation training before instruments | Experimental | Group A performed simulation training before the recognition of real surgical instruments. Receives: Other: Simulation technology |
| Group B:instruments before simulation training | Active comparator | Group B performed the recognition of real surgical instruments without prior simulation training. Receives: Other: Simulation technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time saved for simulation task
Time saved is defined as the duration in seconds from the time the participant correctly submits an instrument prior to the maximum allotted time. Change is measured over repeated sessions on Day 1 and Day 7.
Measured: Day 1 and Day 7
Change in number of errors for simulation task
Number of errors are counted as the number of incorrectly selected instruments on the first attempt. Change is measured over repeated sessions on Day 1 and Day 7.
Measured: Day 1 and Day 7
Change in total score for simulation task
Total score is a gamification-based algorithm dependent upon the number of correct responses in the first attempt and time saved. Change is measured over repeated sessions on Day 1 and Day 7.
Measured: Day 1 and Day 7
Difference in total score for knowledge transfer task
Score is defined as the number of correctly identified instruments from the instrument tray during the instrument recognition task. The difference in score is measured between arms.
Measured: Day 7
Difference in time for knowledge transfer task
Time is the number of seconds (to a maximum of 45) taken to complete the real instrument task. The difference in score is measured between arms.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start21 Oct 2015
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Simulation TechnologyStudies 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Clarke, Nova Scotia Health Authority
- Investigators
- David Clarke, Principal investigator, NSHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894644
- Sponsor's protocol ID
- 100 Nurses
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Transfer and Retention of Simulation-based Learning for Neurosurgical Instruments: a Randomized Trial of 100 Perioperative Nurses
- ClinicalTrials.gov ID
- NCT03894644
- Acronym / sponsor ID
- 100 Nurses
- Conditions
- Focus of Study: Simulation Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 28 Mar 2019 (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.
Rapid technological advances in the last 20 years have led to the exponential adoption of simulation-based learning in nursing education.
Detailed description
Simulation-based learning is designed to engage, challenge and enrich the learner's knowledge base and skill set. It presents the opportunity to experience a variety of clinical scenarios, both common and uncommon, in a safe environment allowing repeated skills training and facilitating the transfer of classroom-knowledge to real situations.Research demonstrates that simulation can improve student engagement and learning and is being increasingly used as an educational strategy for nursing students. This prospective randomized controlled study that was undertaken with the following goals:
- to investigate the effectiveness of simulation-based training in a large sample of perioperative nurses, measured as nurses' learning progress in the simulation environment;
- to determine whether the learning acquired through this training is transferable to recognizing real surgical instruments; and
- to evaluate whether simulation-based learning is retained at least one week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: simulation training before instruments | Experimental | Other: Simulation technologyGroup A performed simulation training before the recognition of real surgical instruments. |
| Group B:instruments before simulation training | Active comparator | Other: Simulation technologyGroup B performed the recognition of real surgical instruments without prior simulation training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Perioperative nurse
- Employed at Queen Elizabeth II Health Sciences Center
Key exclusion criteria (1 listed)
- -Unable to provide informed consent
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 |
|---|---|---|
| Simulation technologyThe intervention involves three consecutive sessions of the PeriopSim™ Instrument Trainer, followed by two consecutive sessions of the PeriopSim™ for Burr Hole Surgery (https://periopsim.com). | Other | Group A: simulation training before instruments, Group B:instruments before simulation training |
Primary outcome
Change in time saved for simulation task
Time frame: Day 1 and Day 7
Time saved is defined as the duration in seconds from the time the participant correctly submits an instrument prior to the maximum allotted time. Change is measured over repeated sessions on Day 1 and Day 7.
Change in number of errors for simulation task
Time frame: Day 1 and Day 7
Number of errors are counted as the number of incorrectly selected instruments on the first attempt. Change is measured over repeated sessions on Day 1 and Day 7.
Change in total score for simulation task
Time frame: Day 1 and Day 7
Total score is a gamification-based algorithm dependent upon the number of correct responses in the first attempt and time saved. Change is measured over repeated sessions on Day 1 and Day 7.
Difference in total score for knowledge transfer task
Time frame: Day 7
Score is defined as the number of correctly identified instruments from the instrument tray during the instrument recognition task. The difference in score is measured between arms.
Difference in time for knowledge transfer task
Time frame: Day 7
Time is the number of seconds (to a maximum of 45) taken to complete the real instrument task. The difference in score is measured between arms.
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 1 Apr 2019.
- Individual participant dataSharing planned: No
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.
David Clarke principal investigator
NSHA
Questions about this trial
What is this clinical trial studying?
A study testing Simulation technology in people with Focus of Study: Simulation Technology, run by Nova Scotia Health Authority.
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 2 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in time saved for simulation task (time frame: Day 1 and Day 7). The study lists 5 primary outcomes in all. 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 1 Apr 2019.