Simulation of Physical IllnessNCT06171815
Comparison of Peer-Led Simulation Facilitation Methods on Nursing Students
A study testing Scenario-based simulation in people with Simulation of Physical Illness and Nurse's Role, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
There are limited studies in the literature on the peer-led facilitator involved in each stage of the simulation in simulation-based experience in nursing education. The purpose of this research is to examine the effect of having a competent senior nursing undergraduate student with simulation knowledge and experience… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness, Nurse's Role
- What is being tested?
- Scenario-based simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Having taken the Health Assessment course,
- Experienced education with simulation for the first time,
- Being willing and able to participate in the study.
Who cannot join
- Incomplete filling of Data Collection Forms,
- Not attending the simulation training on the day and time.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, 34668
Demet İnangil, 05303021160, demet.inangil@sbu.edu.tr
About this study
Official title: University of Health Sciences, Hamidiye Faculty of Nursing
There are limited studies in the literature on the peer-led facilitator involved in each stage of the simulation in simulation-based experience in nursing education. The purpose of this research is to examine the effect of having a competent senior nursing undergraduate student with simulation knowledge and experience as a facilitator at every stage of the simulation, on the effectiveness of the simulation (Simulation Effectiveness Tool), and on the participants' satisfaction and self-confidence in learning.
Method: This research is a prospective, randomized, crossover-designed experimental type of research. Structured Student Information Form, Modified Simulation Effectiveness Tool, Student Satisfaction, and Self-Confidence in Learning Scale will be used to collect data. The population of the research consists of all students enrolled in the first year of the Hamidiye Faculty of Nursing at the University of Health Sciences. Since voluntary participation in the research is based, students who want to participate will constitute the sample. Students will be divided into two groups of eight and will undergo two simulations for two consecutive days. Students in the first arm completed the simulation under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day; Students in the second arm will receive simulation training under the leadership of an instructor facilitator on the first day, and under the leadership of a peer facilitator on the second day.
Read the detailed description
The instructor who facilitates the simulation training has a "Simulation Applications" certificate. The peer facilitator is a 4th-grade student who has received 2-day simulation training and has at least 3 simulation experiences.
Students will be divided into two groups of eight and will undergo two simulations for two consecutive days. Students in the first arm completed the simulation under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day; Students in the second arm will receive simulation training under the leadership of an instructor facilitator on the first day, and under the leadership of a peer facilitator on the second day.
In this study, data will be collected through a 3-stage application process.
- Information
- Respiratory Activity and Diabetes Management topics, which are in the Health Assessment course curriculum, will be explained to first-year students in the spring semester of the 2023-2024 Academic Year at the Faculty of Nursing, where the study will be carried out, by the instructor in charge of the course on the days and hours specified in the course program.
- At the end of the course, explain to the students the purpose of the study, the method, and that the data will be used only for scientific purposes.
- Students who volunteer to participate in the study are explained to the students who volunteer to participate in the study, and their verbal and written consent is obtained by explaining the duration, flow, and expectations of the application.
- Informing students by deciding on the application day and time
- Providing orientation to students by giving them information about the simulation environment and management in the application laboratory on the application day.
- Simulation Training
- Sharing the patient's information for which a scenario text was created for the students before the application.
- Explaining what the goals are expected from students.
- Carrying out both simulation applications on separate days and in a way that students in both groups stay in the simulation environment for the same amount of time.
- Analysis
- Holding a peer evaluation meeting after the simulation, where the groups experience the simulation.
- Discuss students' thoughts about the process (their practices, decisions, and outcomes) regarding their simulation experience.
- Discussing expected and achieved goals.
- Following the analysis meeting, the Structured Student Information and Evaluation Form, Modified Simulation Effectiveness Tool, Student Satisfaction, and Self-Confidence in Learning Scale are administered to the students.
- Conditions
- Simulation of Physical Illness, Nurse's Role
- Being tested
- Scenario-based simulation
- Keywords
- simulation, peer-led, facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario-based simulationBehavioural
Scenario-based simulation prepared for Respiratory Activity and Diabetes Management topics in the course curriculum
| Study group | Role | What they receive |
|---|---|---|
| First Arm | Experimental | Students in the first arm received simulation training under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day. Receives: Behavioral: Scenario-based simulation |
| Second Arm | Experimental | Students in the second arm received simulation training under the leadership of an instructor facilitator on the first day and under the leadership of a peer facilitator on the second day. Receives: Behavioral: Scenario-based simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulation Effectiveness
Output regarding students' perceptions of the effectiveness of learning in a simulation environment. It will be measured with the Modified Simulation Effectiveness Tool. The measurement tool has 19 items and four subscales. Sub-dimensions of the measuring tool; These are prebriefing, learning, confidence and debriefing. The preliminary information sub-dimension consists of two items, the learning sub-dimension consists of six items, the trust sub-dimension consists of six items, and the analysis sub-dimension consists of five items.
Measured: Through study completion, an average of 1 months
Student Satisfaction and Self-Confidence in Learning
Outcome regarding students' attitudes and beliefs about simulation. It will be measured by the Student Satisfaction and Learning Self-Confidence Scale. The scale, which is widely used to measure students' attitudes and beliefs about simulation, was published by the National League for Nurses (NLN) (Franklin, Burns and Lee 2014). It consists of two subscales: "satisfaction with learning" and "self-confidence" and a total of 13 items. In the satisfaction with learning sub-dimension; Five items measuring satisfaction with the teaching method, variety of learning materials, facilitation, motivation and overall suitability of the simulation are included in the self-confidence subscale; There are eight sub-items in content adequacy: self-confidence, content necessity, skill development, available resources and information on how to get help to solve clinical problems in the simulation.
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation of Physical IllnessStudies 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
- Crossover
- Model description
- This research is a prospective, randomized, crossover-designed experimental type research.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171815
- Sponsor's protocol ID
- 2023/16-25
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Niu Y, Liu T, Li K, Sun M, Sun Y, Wang X, Yang X. Effectiveness of simulation debriefing methods in nursing education: A systematic review and meta-analysis. Nurse Educ Today. 2021 Dec;107:105113. doi: 10.1016/j.nedt.2021.105113. Epub 2021 Aug 27.
PubMed 34492539
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Health Sciences, Hamidiye Faculty of Nursing
- ClinicalTrials.gov ID
- NCT06171815
- Acronym / sponsor ID
- 2023/16-25
- Conditions
- Simulation of Physical Illness, Nurse's Role
- Keywords
- simulation, peer-led, facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 15 Dec 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.
There are limited studies in the literature on the peer-led facilitator involved in each stage of the simulation in simulation-based experience in nursing education. The purpose of this research is to examine the effect of having a competent senior nursing undergraduate student with simulation knowledge and experience as a facilitator at every stage of the simulation, on the effectiveness of the simulation (Simulation Effectiveness Tool), and on the participants' satisfaction and self-confidence in learning.
Method: This research is a prospective, randomized, crossover-designed experimental type of research. Structured Student Information Form, Modified Simulation Effectiveness Tool, Student Satisfaction, and Self-Confidence in Learning Scale will be used to collect data. The population of the research consists of all students enrolled in the first year of the Hamidiye Faculty of Nursing at the University of Health Sciences. Since voluntary participation in the research is based, students who want to participate will constitute the sample. Students will be divided into two groups of eight and will undergo two simulations for two consecutive days. Students in the first arm completed the simulation under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day; Students in the second arm will receive simulation training under the leadership of an instructor facilitator on the first day, and under the leadership of a peer facilitator on the second day.
Detailed description
The instructor who facilitates the simulation training has a "Simulation Applications" certificate. The peer facilitator is a 4th-grade student who has received 2-day simulation training and has at least 3 simulation experiences.
Students will be divided into two groups of eight and will undergo two simulations for two consecutive days. Students in the first arm completed the simulation under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day; Students in the second arm will receive simulation training under the leadership of an instructor facilitator on the first day, and under the leadership of a peer facilitator on the second day.
In this study, data will be collected through a 3-stage application process.
- Information
- Respiratory Activity and Diabetes Management topics, which are in the Health Assessment course curriculum, will be explained to first-year students in the spring semester of the 2023-2024 Academic Year at the Faculty of Nursing, where the study will be carried out, by the instructor in charge of the course on the days and hours specified in the course program.
- At the end of the course, explain to the students the purpose of the study, the method, and that the data will be used only for scientific purposes.
- Students who volunteer to participate in the study are explained to the students who volunteer to participate in the study, and their verbal and written consent is obtained by explaining the duration, flow, and expectations of the application.
- Informing students by deciding on the application day and time
- Providing orientation to students by giving them information about the simulation environment and management in the application laboratory on the application day.
- Simulation Training
- Sharing the patient's information for which a scenario text was created for the students before the application.
- Explaining what the goals are expected from students.
- Carrying out both simulation applications on separate days and in a way that students in both groups stay in the simulation environment for the same amount of time.
- Analysis
- Holding a peer evaluation meeting after the simulation, where the groups experience the simulation.
- Discuss students' thoughts about the process (their practices, decisions, and outcomes) regarding their simulation experience.
- Discussing expected and achieved goals.
- Following the analysis meeting, the Structured Student Information and Evaluation Form, Modified Simulation Effectiveness Tool, Student Satisfaction, and Self-Confidence in Learning Scale are administered to the students.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a prospective, randomized, crossover-designed experimental type research.
| Arm | Type | Receives |
|---|---|---|
| First Arm | Experimental | Behavioral: Scenario-based simulationStudents in the first arm received simulation training under the leadership of a peer facilitator on the first day, and under the leadership of an instructor facilitator on the second day. |
| Second Arm | Experimental | Behavioral: Scenario-based simulationStudents in the second arm received simulation training under the leadership of an instructor facilitator on the first day and under the leadership of a peer facilitator on the second day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or older,
- Having taken the Health Assessment course,
- Experienced education with simulation for the first time,
- Being willing and able to participate in the study.
Key exclusion criteria (2 listed)
- Incomplete filling of Data Collection Forms,
- Not attending the simulation training on the day and time.
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 |
|---|---|---|
| Scenario-based simulationScenario-based simulation prepared for Respiratory Activity and Diabetes Management topics in the course curriculum | Behavioural | First Arm, Second Arm |
Primary outcome
Simulation Effectiveness
Time frame: Through study completion, an average of 1 months
Output regarding students' perceptions of the effectiveness of learning in a simulation environment. It will be measured with the Modified Simulation Effectiveness Tool. The measurement tool has 19 items and four subscales. Sub-dimensions of the measuring tool; These are prebriefing, learning, confidence and debriefing. The preliminary information sub-dimension consists of two items, the learning sub-dimension consists of six items, the trust sub-dimension consists of six items, and the analysis sub-dimension consists of five items.
Student Satisfaction and Self-Confidence in Learning
Time frame: Through study completion, an average of 1 months
Outcome regarding students' attitudes and beliefs about simulation. It will be measured by the Student Satisfaction and Learning Self-Confidence Scale. The scale, which is widely used to measure students' attitudes and beliefs about simulation, was published by the National League for Nurses (NLN) (Franklin, Burns and Lee 2014). It consists of two subscales: "satisfaction with learning" and "self-confidence" and a total of 13 items. In the satisfaction with learning sub-dimension; Five items measuring satisfaction with the teaching method, variety of learning materials, facilitation, motivation and overall suitability of the simulation are included in the self-confidence subscale; There are eight sub-items in content adequacy: self-confidence, content necessity, skill development, available resources and information on how to get help to solve clinical problems in the simulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 34492539Niu Y, Liu T, Li K, Sun M, Sun Y, Wang X, Yang X. Effectiveness of simulation debriefing methods in nursing education: A systematic review and meta-analysis. Nurse Educ Today. 2021 Dec;107:105113. doi: 10.1016/j.nedt.2021.105113. Epub 2021 Aug 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scenario-based simulation in people with Simulation of Physical Illness and Nurse's Role, run by Istanbul Saglik Bilimleri 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: status not confirmed, as of the sponsor's last update on 15 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demet İnangil (05303021160, demet.inangil@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulation Effectiveness (time frame: Through study completion, an average of 1 months). 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?
On the ClinicalTrials.gov record for NCT06171815, which also lists 1 linked publication.
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 15 Dec 2023.