StressNCT04199221
Use of Stress Inoculation Training in Medical Education
A study testing Stress Innoculation Training (SIT) and Extra attempt in people with Stress, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Stress Innoculation Training (SIT) and Extra attempt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 29 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st and 2nd year medical students who are at least 18 years old
Who cannot join
- Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice.
Read the detailed description
This is a study examining stress inoculation training and its potential role in medical education. The medical field exposes students and providers to various stressful situations each and every day. Various organizations including military organizations have introduced concepts of stress inoculation training (SIT) to help learners manage these situations to produce optimal performance.
- Conditions
- Stress
- Being tested
- Stress Innoculation Training (SIT), Extra attempt
- Keywords
- Stress Inoculation, Medical Education, Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Innoculation Training (SIT)Behavioural
1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.
Extra attemptBehavioural
an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios
| Study group | Role | What they receive |
|---|---|---|
| Lecture | No intervention | an initial brief lecture with no further training |
| Stress management | Experimental | an initial brief lecture with stress management lecture Receives: Behavioral: Stress Innoculation Training (SIT) |
| Hands-on training | Active comparator | an initial brief lecture with addition hands-on training for the task Receives: Behavioral: Extra attempt |
| Stress management and hands-on training | Experimental | an initial brief lecture with both stress management lecture and additional hands-on training Receives: Behavioral: Stress Innoculation Training (SIT); Behavioral: Extra attempt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety - visual analog
Change in anxiety will be assessed using the Visual Anxiety Scale (VAS/VAS-A), a widely used scale that has been validated in multiple settings to detect changes in anxiety level. A 10cm line will be drawn on the screen and participants will be asked to rate their level of anxiety by clicking somewhere on the line - the leftmost portion coinciding with no anxiety, the rightmost portion coinciding with extreme anxiety. Each millimeter to the right of the initial start of the line counts as 1 point out of 100.
Measured: Baseline to up to 3 weeks
Change in state-trait anxiety
Spielberger State-Trait Anxiety Inventory 6 (STAI-6) will be used to measure state-trait anxiety. The STAI-6 is a validated 6-question form of the STAI-Y, a commonly used and validated measure of anxiety.
Measured: Baseline to up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start26 Aug 2021
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan J Lewis, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199221
- Sponsor's protocol ID
- HM20014865
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2019
- Last updated
- 3 Jan 2024
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Stress Inoculation Training in Medical Education
- ClinicalTrials.gov ID
- NCT04199221
- Acronym / sponsor ID
- HM20014865
- Conditions
- Stress
- Keywords
- Stress Inoculation, Medical Education, Simulation Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 13 Dec 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.
The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice.
Detailed description
This is a study examining stress inoculation training and its potential role in medical education. The medical field exposes students and providers to various stressful situations each and every day. Various organizations including military organizations have introduced concepts of stress inoculation training (SIT) to help learners manage these situations to produce optimal performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lecture | No intervention | –an initial brief lecture with no further training |
| Stress management | Experimental | Behavioral: Stress Innoculation Training (SIT)an initial brief lecture with stress management lecture |
| Hands-on training | Active comparator | Behavioral: Extra attemptan initial brief lecture with addition hands-on training for the task |
| Stress management and hands-on training | Experimental | Behavioral: Stress Innoculation Training (SIT), Behavioral: Extra attemptan initial brief lecture with both stress management lecture and additional hands-on training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1st and 2nd year medical students who are at least 18 years old
Key exclusion criteria (2 listed)
- Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs)
- Pregnant women
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 |
|---|---|---|
| Stress Innoculation Training (SIT)1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training. | Behavioural | Stress management, Stress management and hands-on training |
| Extra attemptan extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios | Behavioural | Hands-on training, Stress management and hands-on training |
Primary outcome
Change in anxiety - visual analog
Time frame: Baseline to up to 3 weeks
Change in anxiety will be assessed using the Visual Anxiety Scale (VAS/VAS-A), a widely used scale that has been validated in multiple settings to detect changes in anxiety level. A 10cm line will be drawn on the screen and participants will be asked to rate their level of anxiety by clicking somewhere on the line - the leftmost portion coinciding with no anxiety, the rightmost portion coinciding with extreme anxiety. Each millimeter to the right of the initial start of the line counts as 1 point out of 100.
Change in state-trait anxiety
Time frame: Baseline to up to 3 weeks
Spielberger State-Trait Anxiety Inventory 6 (STAI-6) will be used to measure state-trait anxiety. The STAI-6 is a validated 6-question form of the STAI-Y, a commonly used and validated measure of anxiety.
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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.
Nathan J Lewis, MD principal investigator
Virginia Commonwealth 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 Stress Innoculation Training (SIT) and Extra attempt in people with Stress, run by Virginia Commonwealth 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Jan 2024. 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 was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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 anxiety - visual analog (time frame: Baseline to up to 3 weeks). The study lists 2 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 3 Jan 2024.