Septic ShockNCT07032779
Effect of Simulation Application in Septic Shock Management
A study testing simulation in people with Septic Shock, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to determine the effect of the Tag Team Patient Safety Simulation application applied to second-year students of a university's Nursing Department on their knowledge level, patient safety attitudes and self-confidence levels. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- What is being tested?
- simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2023to 15 Jul 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students who are registered in the Internal Medicine Nursing course in the 2023-2024 academic year,
- Participated in the "Shock and Nursing Management" theoretical course in the Internal Medicine Nursing course,
- Completed the pre-test and post-tests in the study,
- Consent to the participate in the study
Who cannot join
- Students who did not participate in the theoretical and simulation application stages of the study,
- Did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Simulation Application on Knowledge Level, Patient Safety Attitude and Self-Confidence Levels in Septic Shock Management
This research will be conducted to determine the effect of the Tag Team Patient Safety Simulation application applied to second-year students of a university's Nursing Department on their knowledge level, patient safety attitudes and self-confidence levels.
Read the detailed description
Introduction and Aim: Simulation education is a method that aims to provide students with artificial or virtual experience by providing them with a safe environment where real-life conditions are created. This research will be conducted to determine the effect of the Tag Team Patient Safety Simulation application applied to second-year students of a university's Nursing Department on their knowledge level, patient safety attitudes and self-confidence levels.
Methods: The research will be conducted in a quasi-experimental research design with a control group in a pre-test post-test design. The sample of the research will consist of students studying in the nursing department of a university and taking the Internal Medicine Nursing Course. Data will be collected in 2 time periods after theoretical information on the subject of septic shock is given, after the simulation application and at the end of the clinical application of the Internal Medicine Nursing course. After the septic shock scenario to be used in the research and the preliminary preparations for the simulation are completed, the students in the intervention group will be given the Tag Team Patient Safety Simulation application. No additional application will be made in the control group. Data were collected using the Personal Information Form, the Patient Safety Scale in Health Professional Education, the Student Satisfaction and Self-Confidence Scale in Learning, and the Septic Shock Knowledge Test.
Conclusions: As a result of the research, it is anticipated that the knowledge levels of students regarding patient care in shock will be increased, patient safety behaviors and self-confidence will be increased.Amasya University
- Conditions
- Septic Shock
- Being tested
- simulation
- Keywords
- simulation, education, nursing
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationOther
the students in the intervention group will have the Tag Team Patient Safety Simulation application. The students in the simulation group will be divided into 2 groups and each group will have the Tag Team Patient Safety Simulation application with the same scenario. The students in the labeling group will be included in the scenario as the scenario progresses. It will start with 4 students at the beginning, but with labeling, 7-8 students in each group will take the role of the actors, and the other students will take the role of the audience.
| Study group | Role | What they receive |
|---|---|---|
| simulation | Experimental | After the septic shock scenario and preliminary preparations for the simulation to be used in the study are completed, the students in the intervention group will have the Tag Team Patient Safety Simulation application. The students in the simulation group will be divided into 2 groups and each group will have the Tag Team Patient Safety Simulation application with the same scenario. The students in the labeling group will be included in the scenario as the scenario progresses. It will start with 4 students at the beginning, but with labeling, 7-8 students in each group will take the role of the actors, and the other students will take the role of the audience. The simulation play will consist of a prologue, two acts, an intermission, an informational and an epilogue. Receives: Other: simulation |
| control | No intervention | The students in the control group will not have the simulation application, and only the data collection forms will be filled out in the 2 specified time periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Safety in Education of Health Professionals Scale
Patient Safety in Education of Health Professionals Scale (SPEHGÖ): The Patient Safety in Education of Health Professionals Scale (SPEGHÖ); The scale; It has been reported as valid and reliable for the Turkish society with its original structure consisting of two main dimensions, 6 sub-dimensions, and 23 items. The scale; is a two-level measurement tool and consists of two main dimensions as "Class" and "Clinical environment". The six sub-dimensions in both main dimensions are; working as a team with other healthcare professionals (6 items), effective communication (3 items), management of security risks (3 items), understanding human and environmental factors (3 items), recognizing, intervening and revealing unexpected events and near-errors (4 items), safety culture (4 items). The increase in the total score average for the main and sub-dimensions indicates that the knowledge and competence regarding patient safety has increased
Measured: 4 week
Student Satisfaction and Self-Confidence in Learning Scale
Student Satisfaction and Self-Confidence in Learning Scale: The validity and reliability study of the Student Satisfaction and Self-Confidence in Learning Scale in Turkish was conducted by Ünver et al. The total number of items was reduced to 12 during the adaptation of the scale to Turkish. The scale consists of the subheadings "Satisfaction with Current Learning" (5 items) and "Self-Confidence in Learning" (7 items). The sum of the sub-dimensions of the scale does not give the total score. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase
Measured: 4 week
Septic Shock Knowledge Test
Septic Shock Knowledge Test: The knowledge test will consist of 15 questions regarding septic shock physiology, symptoms and treatment. The questions in the knowledge test will be sent to 5 experts and content validity will be performed.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start24 Nov 2023
- Primary completion22 Jan 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032779
- Sponsor's protocol ID
- NU-568
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simulation Application on Knowledge Level, Patient Safety Attitude and Self-Confidence Levels in Septic Shock Management
- ClinicalTrials.gov ID
- NCT07032779
- Acronym / sponsor ID
- NU-568
- Conditions
- Septic Shock
- Keywords
- simulation, education, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 24 Jun 2025 (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.
This research will be conducted to determine the effect of the Tag Team Patient Safety Simulation application applied to second-year students of a university's Nursing Department on their knowledge level, patient safety attitudes and self-confidence levels.
Detailed description
Introduction and Aim: Simulation education is a method that aims to provide students with artificial or virtual experience by providing them with a safe environment where real-life conditions are created. This research will be conducted to determine the effect of the Tag Team Patient Safety Simulation application applied to second-year students of a university's Nursing Department on their knowledge level, patient safety attitudes and self-confidence levels.
Methods: The research will be conducted in a quasi-experimental research design with a control group in a pre-test post-test design. The sample of the research will consist of students studying in the nursing department of a university and taking the Internal Medicine Nursing Course. Data will be collected in 2 time periods after theoretical information on the subject of septic shock is given, after the simulation application and at the end of the clinical application of the Internal Medicine Nursing course. After the septic shock scenario to be used in the research and the preliminary preparations for the simulation are completed, the students in the intervention group will be given the Tag Team Patient Safety Simulation application. No additional application will be made in the control group. Data were collected using the Personal Information Form, the Patient Safety Scale in Health Professional Education, the Student Satisfaction and Self-Confidence Scale in Learning, and the Septic Shock Knowledge Test.
Conclusions: As a result of the research, it is anticipated that the knowledge levels of students regarding patient care in shock will be increased, patient safety behaviors and self-confidence will be increased.Amasya University
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulation | Experimental | Other: simulationAfter the septic shock scenario and preliminary preparations for the simulation to be used in the study are completed, the students in the intervention group will have the Tag Team Patient Safety Simulation application. The students in the simulation group will be divided into 2 groups and each group will have the Tag Team Patient Safety Simulation application with the same scenario. The students in the labeling group will be included in the scenario as the scenario progresses. It will start with 4 students at the beginning, but with labeling, 7-8 students in each group will take the role of the actors, and the other students will take the role of the audience. The simulation play will consist of a prologue, two acts, an intermission, an informational and an epilogue. |
| control | No intervention | –The students in the control group will not have the simulation application, and only the data collection forms will be filled out in the 2 specified time periods. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Students who are registered in the Internal Medicine Nursing course in the 2023-2024 academic year,
- Participated in the "Shock and Nursing Management" theoretical course in the Internal Medicine Nursing course,
- Completed the pre-test and post-tests in the study,
- Consent to the participate in the study
Key exclusion criteria (2 listed)
- Students who did not participate in the theoretical and simulation application stages of the study,
- Did not consent to participate in the study
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 |
|---|---|---|
| simulationthe students in the intervention group will have the Tag Team Patient Safety Simulation application. The students in the simulation group will be divided into 2 groups and each group will have the Tag Team Patient Safety Simulation application with the same scenario. The students in the labeling group will be included in the scenario as the scenario progresses. It will start with 4 students at the beginning, but with labeling, 7-8 students in each group will take the role of the actors, and the other students will take the role of the audience. | Other | simulation |
Primary outcome
Patient Safety in Education of Health Professionals Scale
Time frame: 4 week
Patient Safety in Education of Health Professionals Scale (SPEHGÖ): The Patient Safety in Education of Health Professionals Scale (SPEGHÖ); The scale; It has been reported as valid and reliable for the Turkish society with its original structure consisting of two main dimensions, 6 sub-dimensions, and 23 items. The scale; is a two-level measurement tool and consists of two main dimensions as "Class" and "Clinical environment". The six sub-dimensions in both main dimensions are; working as a team with other healthcare professionals (6 items), effective communication (3 items), management of security risks (3 items), understanding human and environmental factors (3 items), recognizing, intervening and revealing unexpected events and near-errors (4 items), safety culture (4 items). The increase in the total score average for the main and sub-dimensions indicates that the knowledge and competence regarding patient safety has increased
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: 4 week
Student Satisfaction and Self-Confidence in Learning Scale: The validity and reliability study of the Student Satisfaction and Self-Confidence in Learning Scale in Turkish was conducted by Ünver et al. The total number of items was reduced to 12 during the adaptation of the scale to Turkish. The scale consists of the subheadings "Satisfaction with Current Learning" (5 items) and "Self-Confidence in Learning" (7 items). The sum of the sub-dimensions of the scale does not give the total score. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase
Septic Shock Knowledge Test
Time frame: 4 week
Septic Shock Knowledge Test: The knowledge test will consist of 15 questions regarding septic shock physiology, symptoms and treatment. The questions in the knowledge test will be sent to 5 experts and content validity will be performed.
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 24 Jun 2025.
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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.
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 simulation in people with Septic Shock, run by Amasya University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 24 Jun 2025. 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 Turkey (Türkiye). 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?
Patient Safety in Education of Health Professionals Scale (time frame: 4 week). The study lists 3 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 24 Jun 2025.