LeadershipRCTNCT06638203
The Effect of a Game on the Development of Leadership Behaviors of Nursing Students
A study testing The 2-hour Exemplary Leadership Course (ELC) and The NurseLead in Progress Game in people with Leadership, run by Canberk Akdeniz at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial is to examine the effect of a leadership role-playing computer game on nursing students' leadership practices. The main questions it aims to answer are: RQ1: Will participants in the intervention group perform better on the Five Practices of Exemplary Leadership Achievement… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Leadership
- What is being tested?
- The 2-hour Exemplary Leadership Course (ELC) and The NurseLead in Progress Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 1 Feb 2025
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between 18 and 25 years old.
- Informed consent must be obtained from the participant.
- Participants must have no visual and/or hearing impairments.
- Participants must be students in a four-year nursing bachelor's program.
- Participants must be in the 3rd or 4th year of their bachelor's program.
- Participants must have completed a leadership course during their bachelor's education.
Who cannot join
- Individuals who are younger than 18 or older than 25 years old.
- Individuals with visual and/or hearing impairments.
- Individuals who are currently receiving or have received training related to leadership outside of their program.
- Individuals holding a diploma in a field other than nursing.
- Individuals currently studying in a field other than nursing.
- Individuals who have suspended their bachelor's education.
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- Individuals who are in the preparatory year, 1st, or 2nd year of the bachelor's program.
- Individuals who have not taken any leadership-related courses during their bachelor's education.
- Individuals with a conflict of interest due to close relationships with the researchers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
HEP-SEN Union - Ankara Prof. Dr. Perihan Velioglu Branch
Ankara, Cankaya, 06530
About this study
Official title: The Effect of "NurseLead in Progress" Game on the Development of Transformational Leadership Behaviors of Nursing Students: A Randomized Controlled Study
The aim of this randomized controlled trial is to examine the effect of a leadership role-playing computer game on nursing students' leadership practices. The main questions it aims to answer are:
RQ1: Will participants in the intervention group perform better on the Five Practices of Exemplary Leadership Achievement Test (5PELAT) after the game?
Read more
- RQ1a: Is the average score of the intervention group on the Five Practices of Exemplary Leadership Achievement Test significantly higher than the average score of the control group after the game?
- RQ1b: Is the difference between pre-test and post-test scores on the Five Practices of Exemplary Leadership Achievement Test significantly greater in the intervention group compared to the control group?
RQ2: Will participants in the intervention group report higher self-assessments of their own leadership practices after the game compared to the control group?
- RQ2a: Is the average score of the intervention group on the Student Leadership Practices Inventory (SLPI) significantly higher than the average score of the control group after the game?
- RQ2b: Is the difference between pre-test and post-test scores on the Student Leadership Practices Inventory significantly greater in the intervention group compared to the control group?
Researchers will compare the leadership course \& game playing intervention to only getting the leadership course to see if the combined version works better in developing nursing students' transformational leadership. Participants will:
- Take the leadership course and play the leadership game or only take the course.
- Complete Five Practices of Exemplary Leadership Achievement Test (5PELAT) and the Student Leadership Practices Inventory (SLPI) before and after the intervention.
Read the detailed description
Study Design The study is planned as a parallel group randomized controlled study to determine the effect of the "NurseLead in Progress" computer game on subjective and objective leadership measurement. At the end of the study, it is aimed to evaluate the effect of getting the leadership course only to combining it to a role-playing involved gameplay. The experiment will not measure the effectiveness of the game intervention, but its efficacy under ideal conditions. In this context, an explanatory design will be used. Since the number of participants was previously calculated in the light of reference articles, a fixed design will be used in terms of the number of participants. CONSORT 2024 will be used for reporting the research.
Settings and Participants The course and the game intervention will take place in the office of a nursing union, a central location based in Ankara/Türkiye. The population is the nursing students in Ankara/Türkiye as well. In Ankara, there are 4 public and 6 private universities that gives 4 years BSN education and total number of nursing students is nearly 5000. Based on the lowest effect size in the reference articles (Foli et al, 2014; Marath \& Ramachandra, 2015) it was calculated that there should be 18 students in the groups with a ratio of n intervention/ n control=1 to provide 80% power, 0.99 effect size (Cohen's) and 2.5% Type I error (One-way hypothesis) in order to compare two independent group averages. In order to reach the largest sample size to test all hypotheses, it was planned to include 25 students each in the intervention and control groups with an estimated 25% dropout rate in the groups, considering the long-term data collection phase and the variability in motivation to participate in extracurricular activities. The inclusion and exclusion criteria is mentioned elsewhere. The nursing students meet the inclusion criteria will be informed about the purpose, content and method of the study and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. Determination of the experimental and control groups will be provided by https://www.randomizer.org/ website.
Instruments Author prepared Introductory Information Form will be used to investigate baseline comparisons. Author-prepared Five Practices of Exemplary Leadership Achievement Test (5PELAT) will be used to collect objective data on the leadership development. In addition, Student Leadership Practices Inventory (SLPI), by Kouzes and Posner will be used to collect nursing students' perspective on their leadership development.
The Introductory Information form consists of two parts. The first part includes 10 questions about students' individual and academic characteristics and the second part includes 10 questions about their participation in professional activities.
Five Practices of Exemplary Leadership Achievement Test consists of 10 questions, each with five options, on a sample scenario, analyzed according to the Five Practices of Exemplary Leadership model. It will be administered to all participants in the pre-test and post-test in order to provide an objective assessment of the change in leadership behaviors. The questions have been prepared together with experts and finalized with the opinions of a widely participated expert panel.
The Student Leadership Practices Inventory, developed by Kouzes and Posner for undergraduate students to assess their own leadership practices, has 5 sub-dimensions. The sub-dimensions of the inventory, which consists of 30 questions in total, are modeling the way, inspiring a shared vision, challenging the process, enabling others to act and, and encouraging the heart. The 5-point Likert scale has no reverse items. There are 6 questions for each sub-dimension. The scores that can be obtained from each sub-dimension are between 6-30. The total score that can be obtained from the scale is between 30-150. The higher the score obtained from the scale, the more positive the students' attitude towards their own leadership practices. It is planned to be applied as a pre and posttest to measure the participants' evaluations of their leadership behaviors. The inventory will be applied in Turkish format and the related adaptation study was carried out by the authors and presented as an oral presentation at the 8th International 19th National Nursing Congress at Hacettepe University Sıhhiye Cultural Center on September 25-28, 2024. Cronbach's alpha coefficient for the self-assessment version to be used in the experiment was .959. The CVR values were above 0.9 and each CVI for the sub-dimensions was above 0.97. In confirmatory factor analysis, all factor loads were above 0.30.
Data Collection
Pre-Randomization Before randomization, we will invite all eligible students to participate in the study by signing a voluntary consent form. An independent expert (A), not affiliated with the research team, will assess the students' eligibility based on inclusion and exclusion criteria. From those who meet the criteria, another independent expert (B) will use appropriate software to randomly select 50 participants through systematic random selection.
Randomization and Blinding An independent expert (C) will randomly allocate the 50 selected students into control and intervention groups using block randomization. Blinding process is detailed in elsewhere.
Consent Collection and Leadership Course Implementation We will provide all participating students (n=50) with Voluntary Consent Forms and ask them to return the signed forms. Following this, we will conduct a 2-hour Leadership Training Program. The program aims to refresh participants' theoretical knowledge of leadership, offer insights into key elements for effective leader-follower interactions, and ensure that all participants have a similar level of theoretical understanding and practical potential before the intervention. Additionally, the program will include case study discussions based on the Exemplary Leadership Framework.
Administration of Introductory Information Form and Pre-Test All students who complete the training program will fill out the introductory form, which is designed to identify any initial differences. At the same time, each participant will take the Five Practices of Exemplary Leadership Achievement Test and the Student Leadership Practices Inventory.
Game Implementation After completing the course, participants in the intervention group will engage in the game. Designed for five students per session, the game consists of five sections and lasts approximately one hour. Each section aligns with one of the Five Practices of Exemplary Leadership. In each section, one student will assume the role of the leader, while the other four act as followers. The game's main objective is to guide a newly appointed charge nurse in making the right decisions when faced with challenges, ultimately achieving the final goals. After the game, a debriefing session will be held, where responses will be analyzed with experts and students. Performance in the game will not be formally measured, as it is purely a learning experience designed to provide opportunities for students to lead and effectively share as followers. The game is intended to activate the experiential learning phase of Kolb's Learning Model.
Post-Test Two weeks after the intervention group completes the game and feedback sessions, the post-test will be administered. Both the intervention and control groups will take the achievement test and the Student Leadership Practices Inventory. The achievement test in this phase will be identical in scenario and questions to the first test.
Data Analysis The data will be analyzed using the SPSS 25.0 package program. The descriptive characteristics of the participants will be analyzed using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Differences in characteristics between the intervention and control groups will be analyzed using independent t-tests or chi-square tests. In addition, the initial comparability of the groups, i.e. the success of random assignment, will be statistically tested. Paired t-tests will be used to analyze within-group outcome differences between the pretest and posttest. For one-way hypothesis tests, all results with p<.025 will be considered statistically significant. ITT and PP analyses will be used to analyze the data of the participants who were separated from the control and intervention groups within the sample. If the characteristics of the data are appropriate, analyses such as cox regression, Manova, multivariate regression, two-way analysis of variance in repeated measures will also be performed to analyze whether the outcome is caused by the intervention (causality).
Ethical Considerations Ethical approval was obtained from Hacettepe University's Social Sciences and Humanities Researches Ethics Board. Additionally, permission was secured from Kouzes and Posner for the adaptation of the leadership inventory, and approval for its use was granted by Wiley. Institutional permissions were obtained from the relevant union for the office where the intervention will take place. Participation in the game development and gameplay will be free of charge for the participants. Furthermore, their travel expenses to the office where the trial will be conducted will be covered by Researcher #1. Participants within each group will be selected from different universities, ensuring that no group consists of students from the same institution.
- Conditions
- Leadership
- Being tested
- The 2-hour Exemplary Leadership Course (ELC), The NurseLead in Progress Game
- Keywords
- Computer Games, Leadership, Nursing Students, Role Playing, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 2-hour Exemplary Leadership Course (ELC)Other
This two-hour course, based on the Five Exemplary Leadership Model, aims to refresh participants' theoretical understanding of leadership while providing insights into effective leader-follower interactions through practical scenarios. The session will begin with an exploration of the nature of leadership, including its philosophical and historical context. The significance of leadership in nursing will be emphasized, highlighting its impact on education, clinical practice, and the profession overall. Participants will examine the key roles of nurse leaders, focusing on modeling the way, inspiring a shared vision, challenging the process, enabling others to act, and encouraging the heart. Content Outline:
- The Nature and Definition of Leadership (5 minutes)
- Leadership and Its Importance in Nursing (15 minutes)
- Transformational Leadership and Its Components (40 minutes)
- Positive Leader-Follower Interactions (15 minutes)
- Case Study Discussions (45 minutes)
The NurseLead in Progress GameOther
Developed collaboratively by the author and a company, this unpublished game focuses on role-playing leader-follower interactions to navigate scenarios effectively. Designed for five students per session, the game consists of five sections, lasting approximately one hour, with each section corresponding to one of the Five Practices of Exemplary Leadership. In each section, one student takes on the role of leader while the other four act as followers. The main objective is to guide a newly appointed charge nurse in making sound decisions when facing challenges to achieve key goals. Following the game, a debriefing session will allow participants to analyze responses with experts. Performance will not be formally evaluated, as the game serves as a learning experience, enabling students to lead and engage as followers. This activity aims to activate the experiential learning phase of Kolb's Learning Model.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants who will complete the leadership course and then engage in the leadership game Receives: Other: The 2-hour Exemplary Leadership Course (ELC); Other: The NurseLead in Progress Game |
| Control Group | Active comparator | Participants who will complete the leadership course only. Receives: Other: The 2-hour Exemplary Leadership Course (ELC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transformational Leadership Development (Objective)
Five Practices of Exemplary Leadership Achievement Test (5PELAT)
The 5PELAT is a test developed by the authors, comprising 10 questions, each featuring 5 response options based on various sample scenarios. These scenarios are analyzed in alignment with the Five Practices of Exemplary Leadership model. Each question and its corresponding answers have been crafted in collaboration with subject matter experts and refined through feedback from an expert panel, ensuring their relevance and effectiveness in evaluating leadership. This development process aims to provide reliable insights into participants' understanding and application of exemplary leadership practices.
Measured: Before the interventions, in both groups (baseline) 2 weeks after the interventions, in both groups. (1st measurement) 4 weeks after the interventions, in both groups. (2nd measurement) In total, time frame is 6 weeks.
Secondary outcomes (1)
Transformational Leadership Development (Perspective)
The Student Leadership Practices Inventory (SLPI-Self)
The SLPI developed by Kouzes and Posner for students to assess their own leadership practices, has 30 items (no reverse coding) and 5 sub-dimensions. There are 6 questions for each sub-dimension. The scores that can be obtained from each sub-dimension are between 6-30. The total score that can be obtained from the scale is between 30-150. The higher the score obtained from the scale, the more positive the students' attitude towards their own leadership practices.
Measured: Before the interventions, in both groups (baseline) 2 weeks after the interventions, in both groups. (1st measurement) 4 weeks after the interventions, in both groups. (2nd measurement) In total, time frame is 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Jan 2025
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for LeadershipStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canberk Akdeniz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Canberk Akdeniz, Hacettepe University
- Investigators
- Canberk Akdeniz, Principal investigator, HEP-SEN Union (Senior Advisor)Sergül Duygulu, Prof., Study director, Hacettepe University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638203
- Sponsor's protocol ID
- E-66777842-300-00003535955
- Acronym
- RCT
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to upload the raw, de-identified data to Mendeley Data. The publication of the dataset will be contingent upon the manuscript's publication, following the completion of all necessary processes.
Publications
Tunn R, Boutron I, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, de Beyer JA, Hansen Nejstgaard C, Ostengaard L, Hopewell S. Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements. J Clin Epidemiol. 2024 May;169:111309. doi: 10.1016/j.jclinepi.2024.111309. Epub 2024 Feb 29.
PubMed 38428538Marath, U., Ramachandra, (2015). Impact of Leadership Development Package on Leadership Competencies of Undergraduate Nursing Students. Asian J. Nur. Edu. and Research 5(2): April-June 2015; Page221-228. doi: 10.5958/2349-2996.2015.00044.0
Kuruca Ozdemir E, Dinc L. Game-based learning in undergraduate nursing education: A systematic review of mixed-method studies. Nurse Educ Pract. 2022 Jul;62:103375. doi: 10.1016/j.nepr.2022.103375. Epub 2022 Jun 13.
PubMed 35749962Kouzes, James M., Barry Z. Posner. (2017). The Leadership Challenge 6th ed. Hoboken, NJ: Wiley.
Kouzes, James M., Barry Z. Posner. (2013). The Student Leadership Challenge: Facilitation and Activity Guide. San Francisco: Jossey-Bass.
Kolb, D.A. (1984) Experiential Learning: Experience as the Source of Learning and Development. Englewood Cliffs, N.J.: Prentice-Hall
Foli KJ, Braswell M, Kirkpatrick J, Lim E. Development of leadership behaviors in undergraduate nursing students: a service-learning approach. Nurs Educ Perspect. 2014 Mar-Apr;35(2):76-82. doi: 10.5480/11-578.1.
PubMed 24783721Denney, Logan R., "Student Leadership Development: A Focus on Experiential Leadership Orientation Within Higher Education" (2013). Master of Arts in Higher Education (MAHE) Theses. 94. https://pillars.taylor.edu/mahe/94
Petit dit Dariel OJ, Raby T, Ravaut F, Rothan-Tondeur M. Developing the Serious Games potential in nursing education. Nurse Educ Today. 2013 Dec;33(12):1569-75. doi: 10.1016/j.nedt.2012.12.014. Epub 2013 Jan 16.
PubMed 23332500Curtis EA, de Vries J, Sheerin FK. Developing leadership in nursing: exploring core factors. Br J Nurs. 2011 Mar 10-23;20(5):306-9. doi: 10.12968/bjon.2011.20.5.306.
PubMed 21471879Boctor L. Active-learning strategies: the use of a game to reinforce learning in nursing education. A case study. Nurse Educ Pract. 2013 Mar;13(2):96-100. doi: 10.1016/j.nepr.2012.07.010. Epub 2012 Aug 19.
PubMed 22910398Blakely G, Skirton H, Cooper S, Allum P, Nelmes P. Educational gaming in the health sciences: systematic review. J Adv Nurs. 2009 Feb;65(2):259-69. doi: 10.1111/j.1365-2648.2008.04843.x. Epub 2008 Nov 14.
PubMed 19032512Akdeniz C, Duygulu S. Systematic Review on Characteristics and Effects of Leadership Development Interventions for Nursing Students. Nurse Educ. 2024 May-Jun 01;49(3):E147-E152. doi: 10.1097/NNE.0000000000001540. Epub 2023 Nov 16.
PubMed 37994497
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "NurseLead in Progress" Game on the Development of Transformational Leadership Behaviors of Nursing Students: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06638203
- Acronym / sponsor ID
- RCT / E-66777842-300-00003535955
- Conditions
- Leadership
- Keywords
- Computer Games, Leadership, Nursing Students, Role Playing, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Canberk AkdenizUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 15 Oct 2024 (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 aim of this randomized controlled trial is to examine the effect of a leadership role-playing computer game on nursing students' leadership practices. The main questions it aims to answer are:
RQ1: Will participants in the intervention group perform better on the Five Practices of Exemplary Leadership Achievement Test (5PELAT) after the game?
- RQ1a: Is the average score of the intervention group on the Five Practices of Exemplary Leadership Achievement Test significantly higher than the average score of the control group after the game?
- RQ1b: Is the difference between pre-test and post-test scores on the Five Practices of Exemplary Leadership Achievement Test significantly greater in the intervention group compared to the control group?
RQ2: Will participants in the intervention group report higher self-assessments of their own leadership practices after the game compared to the control group?
- RQ2a: Is the average score of the intervention group on the Student Leadership Practices Inventory (SLPI) significantly higher than the average score of the control group after the game?
- RQ2b: Is the difference between pre-test and post-test scores on the Student Leadership Practices Inventory significantly greater in the intervention group compared to the control group?
Researchers will compare the leadership course \& game playing intervention to only getting the leadership course to see if the combined version works better in developing nursing students' transformational leadership. Participants will:
- Take the leadership course and play the leadership game or only take the course.
- Complete Five Practices of Exemplary Leadership Achievement Test (5PELAT) and the Student Leadership Practices Inventory (SLPI) before and after the intervention.
Detailed description
Study Design The study is planned as a parallel group randomized controlled study to determine the effect of the "NurseLead in Progress" computer game on subjective and objective leadership measurement. At the end of the study, it is aimed to evaluate the effect of getting the leadership course only to combining it to a role-playing involved gameplay. The experiment will not measure the effectiveness of the game intervention, but its efficacy under ideal conditions. In this context, an explanatory design will be used. Since the number of participants was previously calculated in the light of reference articles, a fixed design will be used in terms of the number of participants. CONSORT 2024 will be used for reporting the research.
Settings and Participants The course and the game intervention will take place in the office of a nursing union, a central location based in Ankara/Türkiye. The population is the nursing students in Ankara/Türkiye as well. In Ankara, there are 4 public and 6 private universities that gives 4 years BSN education and total number of nursing students is nearly 5000. Based on the lowest effect size in the reference articles (Foli et al, 2014; Marath \& Ramachandra, 2015) it was calculated that there should be 18 students in the groups with a ratio of n intervention/ n control=1 to provide 80% power, 0.99 effect size (Cohen's) and 2.5% Type I error (One-way hypothesis) in order to compare two independent group averages. In order to reach the largest sample size to test all hypotheses, it was planned to include 25 students each in the intervention and control groups with an estimated 25% dropout rate in the groups, considering the long-term data collection phase and the variability in motivation to participate in extracurricular activities. The inclusion and exclusion criteria is mentioned elsewhere. The nursing students meet the inclusion criteria will be informed about the purpose, content and method of the study and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. Determination of the experimental and control groups will be provided by https://www.randomizer.org/ website.
Instruments Author prepared Introductory Information Form will be used to investigate baseline comparisons. Author-prepared Five Practices of Exemplary Leadership Achievement Test (5PELAT) will be used to collect objective data on the leadership development. In addition, Student Leadership Practices Inventory (SLPI), by Kouzes and Posner will be used to collect nursing students' perspective on their leadership development.
The Introductory Information form consists of two parts. The first part includes 10 questions about students' individual and academic characteristics and the second part includes 10 questions about their participation in professional activities.
Five Practices of Exemplary Leadership Achievement Test consists of 10 questions, each with five options, on a sample scenario, analyzed according to the Five Practices of Exemplary Leadership model. It will be administered to all participants in the pre-test and post-test in order to provide an objective assessment of the change in leadership behaviors. The questions have been prepared together with experts and finalized with the opinions of a widely participated expert panel.
The Student Leadership Practices Inventory, developed by Kouzes and Posner for undergraduate students to assess their own leadership practices, has 5 sub-dimensions. The sub-dimensions of the inventory, which consists of 30 questions in total, are modeling the way, inspiring a shared vision, challenging the process, enabling others to act and, and encouraging the heart. The 5-point Likert scale has no reverse items. There are 6 questions for each sub-dimension. The scores that can be obtained from each sub-dimension are between 6-30. The total score that can be obtained from the scale is between 30-150. The higher the score obtained from the scale, the more positive the students' attitude towards their own leadership practices. It is planned to be applied as a pre and posttest to measure the participants' evaluations of their leadership behaviors. The inventory will be applied in Turkish format and the related adaptation study was carried out by the authors and presented as an oral presentation at the 8th International 19th National Nursing Congress at Hacettepe University Sıhhiye Cultural Center on September 25-28, 2024. Cronbach's alpha coefficient for the self-assessment version to be used in the experiment was .959. The CVR values were above 0.9 and each CVI for the sub-dimensions was above 0.97. In confirmatory factor analysis, all factor loads were above 0.30.
Data Collection
Pre-Randomization Before randomization, we will invite all eligible students to participate in the study by signing a voluntary consent form. An independent expert (A), not affiliated with the research team, will assess the students' eligibility based on inclusion and exclusion criteria. From those who meet the criteria, another independent expert (B) will use appropriate software to randomly select 50 participants through systematic random selection.
Randomization and Blinding An independent expert (C) will randomly allocate the 50 selected students into control and intervention groups using block randomization. Blinding process is detailed in elsewhere.
Consent Collection and Leadership Course Implementation We will provide all participating students (n=50) with Voluntary Consent Forms and ask them to return the signed forms. Following this, we will conduct a 2-hour Leadership Training Program. The program aims to refresh participants' theoretical knowledge of leadership, offer insights into key elements for effective leader-follower interactions, and ensure that all participants have a similar level of theoretical understanding and practical potential before the intervention. Additionally, the program will include case study discussions based on the Exemplary Leadership Framework.
Administration of Introductory Information Form and Pre-Test All students who complete the training program will fill out the introductory form, which is designed to identify any initial differences. At the same time, each participant will take the Five Practices of Exemplary Leadership Achievement Test and the Student Leadership Practices Inventory.
Game Implementation After completing the course, participants in the intervention group will engage in the game. Designed for five students per session, the game consists of five sections and lasts approximately one hour. Each section aligns with one of the Five Practices of Exemplary Leadership. In each section, one student will assume the role of the leader, while the other four act as followers. The game's main objective is to guide a newly appointed charge nurse in making the right decisions when faced with challenges, ultimately achieving the final goals. After the game, a debriefing session will be held, where responses will be analyzed with experts and students. Performance in the game will not be formally measured, as it is purely a learning experience designed to provide opportunities for students to lead and effectively share as followers. The game is intended to activate the experiential learning phase of Kolb's Learning Model.
Post-Test Two weeks after the intervention group completes the game and feedback sessions, the post-test will be administered. Both the intervention and control groups will take the achievement test and the Student Leadership Practices Inventory. The achievement test in this phase will be identical in scenario and questions to the first test.
Data Analysis The data will be analyzed using the SPSS 25.0 package program. The descriptive characteristics of the participants will be analyzed using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Differences in characteristics between the intervention and control groups will be analyzed using independent t-tests or chi-square tests. In addition, the initial comparability of the groups, i.e. the success of random assignment, will be statistically tested. Paired t-tests will be used to analyze within-group outcome differences between the pretest and posttest. For one-way hypothesis tests, all results with p<.025 will be considered statistically significant. ITT and PP analyses will be used to analyze the data of the participants who were separated from the control and intervention groups within the sample. If the characteristics of the data are appropriate, analyses such as cox regression, Manova, multivariate regression, two-way analysis of variance in repeated measures will also be performed to analyze whether the outcome is caused by the intervention (causality).
Ethical Considerations Ethical approval was obtained from Hacettepe University's Social Sciences and Humanities Researches Ethics Board. Additionally, permission was secured from Kouzes and Posner for the adaptation of the leadership inventory, and approval for its use was granted by Wiley. Institutional permissions were obtained from the relevant union for the office where the intervention will take place. Participation in the game development and gameplay will be free of charge for the participants. Furthermore, their travel expenses to the office where the trial will be conducted will be covered by Researcher #1. Participants within each group will be selected from different universities, ensuring that no group consists of students from the same institution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: The 2-hour Exemplary Leadership Course (ELC), Other: The NurseLead in Progress GameParticipants who will complete the leadership course and then engage in the leadership game |
| Control Group | Active comparator | Other: The 2-hour Exemplary Leadership Course (ELC)Participants who will complete the leadership course only. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be between 18 and 25 years old.
- Informed consent must be obtained from the participant.
- Participants must have no visual and/or hearing impairments.
- Participants must be students in a four-year nursing bachelor's program.
- Participants must be in the 3rd or 4th year of their bachelor's program.
Key exclusion criteria (9 listed)
- Individuals who are younger than 18 or older than 25 years old.
- Individuals with visual and/or hearing impairments.
- Individuals who are currently receiving or have received training related to leadership outside of their program.
- Individuals holding a diploma in a field other than nursing.
- Individuals currently studying in a field other than nursing.
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 |
|---|---|---|
| The 2-hour Exemplary Leadership Course (ELC)This two-hour course, based on the Five Exemplary Leadership Model, aims to refresh participants' theoretical understanding of leadership while providing insights into effective leader-follower interactions through practical scenarios. The session will begin with an exploration of the nature of leadership, including its philosophical and historical context. The significance of leadership in nursing will be emphasized, highlighting its impact on education, clinical practice, and the profession overall. Participants will examine the key roles of nurse leaders, focusing on modeling the way, inspiring a shared vision, challenging the process, enabling others to act, and encouraging the heart. Content Outline: 1. The Nature and Definition of Leadership (5 minutes) 2. Leadership and Its Importance in Nursing (15 minutes) 3. Transformational Leadership and Its Components (40 minutes) 4. Positive Leader-Follower Interactions (15 minutes) 5. Case Study Discussions (45 minutes) | Other | Control Group, Intervention Group |
| The NurseLead in Progress GameDeveloped collaboratively by the author and a company, this unpublished game focuses on role-playing leader-follower interactions to navigate scenarios effectively. Designed for five students per session, the game consists of five sections, lasting approximately one hour, with each section corresponding to one of the Five Practices of Exemplary Leadership. In each section, one student takes on the role of leader while the other four act as followers. The main objective is to guide a newly appointed charge nurse in making sound decisions when facing challenges to achieve key goals. Following the game, a debriefing session will allow participants to analyze responses with experts. Performance will not be formally evaluated, as the game serves as a learning experience, enabling students to lead and engage as followers. This activity aims to activate the experiential learning phase of Kolb's Learning Model. | Other | Intervention Group |
Primary outcome
Transformational Leadership Development (Objective)
Time frame: Before the interventions, in both groups (baseline) 2 weeks after the interventions, in both groups. (1st measurement) 4 weeks after the interventions, in both groups. (2nd measurement) In total, time frame is 6 weeks.
Five Practices of Exemplary Leadership Achievement Test (5PELAT) The 5PELAT is a test developed by the authors, comprising 10 questions, each featuring 5 response options based on various sample scenarios. These scenarios are analyzed in alignment with the Five Practices of Exemplary Leadership model. Each question and its corresponding answers have been crafted in collaboration with subject matter experts and refined through feedback from an expert panel, ensuring their relevance and effectiveness in evaluating leadership. This development process aims to provide reliable insights into participants' understanding and application of exemplary leadership practices.
1 secondary outcome
Transformational Leadership Development (Perspective)
Time frame: Before the interventions, in both groups (baseline) 2 weeks after the interventions, in both groups. (1st measurement) 4 weeks after the interventions, in both groups. (2nd measurement) In total, time frame is 6 weeks.
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 4 Feb 2025.
- Background: PubMed 38428538Tunn R, Boutron I, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, de Beyer JA, Hansen Nejstgaard C, Ostengaard L, Hopewell S. Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements. J Clin Epidemiol. 2024 May;169:111309. doi: 10.1016/j.jclinepi.2024.111309. Epub 2024 Feb 29.
- BackgroundMarath, U., Ramachandra, (2015). Impact of Leadership Development Package on Leadership Competencies of Undergraduate Nursing Students. Asian J. Nur. Edu. and Research 5(2): April-June 2015; Page221-228. doi: 10.5958/2349-2996.2015.00044.0
- Background: PubMed 35749962Kuruca Ozdemir E, Dinc L. Game-based learning in undergraduate nursing education: A systematic review of mixed-method studies. Nurse Educ Pract. 2022 Jul;62:103375. doi: 10.1016/j.nepr.2022.103375. Epub 2022 Jun 13.
- BackgroundKouzes, James M., Barry Z. Posner. (2017). The Leadership Challenge 6th ed. Hoboken, NJ: Wiley.
- BackgroundKouzes, James M., Barry Z. Posner. (2013). The Student Leadership Challenge: Facilitation and Activity Guide. San Francisco: Jossey-Bass.
- BackgroundKolb, D.A. (1984) Experiential Learning: Experience as the Source of Learning and Development. Englewood Cliffs, N.J.: Prentice-Hall
- Background: PubMed 24783721Foli KJ, Braswell M, Kirkpatrick J, Lim E. Development of leadership behaviors in undergraduate nursing students: a service-learning approach. Nurs Educ Perspect. 2014 Mar-Apr;35(2):76-82. doi: 10.5480/11-578.1.
- BackgroundDenney, Logan R., "Student Leadership Development: A Focus on Experiential Leadership Orientation Within Higher Education" (2013). Master of Arts in Higher Education (MAHE) Theses. 94. https://pillars.taylor.edu/mahe/94
- Background: PubMed 23332500Petit dit Dariel OJ, Raby T, Ravaut F, Rothan-Tondeur M. Developing the Serious Games potential in nursing education. Nurse Educ Today. 2013 Dec;33(12):1569-75. doi: 10.1016/j.nedt.2012.12.014. Epub 2013 Jan 16.
- Background: PubMed 21471879Curtis EA, de Vries J, Sheerin FK. Developing leadership in nursing: exploring core factors. Br J Nurs. 2011 Mar 10-23;20(5):306-9. doi: 10.12968/bjon.2011.20.5.306.
- Background: PubMed 22910398Boctor L. Active-learning strategies: the use of a game to reinforce learning in nursing education. A case study. Nurse Educ Pract. 2013 Mar;13(2):96-100. doi: 10.1016/j.nepr.2012.07.010. Epub 2012 Aug 19.
- Background: PubMed 19032512Blakely G, Skirton H, Cooper S, Allum P, Nelmes P. Educational gaming in the health sciences: systematic review. J Adv Nurs. 2009 Feb;65(2):259-69. doi: 10.1111/j.1365-2648.2008.04843.x. Epub 2008 Nov 14.
- Individual participant dataSharing planned: Yes. We intend to upload the raw, de-identified data to Mendeley Data. The publication of the dataset will be contingent upon the manuscript's publication, following the completion of all necessary processes.
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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.
Canberk Akdeniz principal investigator
HEP-SEN Union (Senior Advisor)
Sergül Duygulu, Prof. study director
Hacettepe University Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 2-hour Exemplary Leadership Course (ELC) and The NurseLead in Progress Game in people with Leadership, run by Canberk Akdeniz 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 6 inclusion and 9 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 4 Feb 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?
Transformational Leadership Development (Objective) (time frame: Before the interventions, in both groups (baseline) 2 weeks after the interventions, in both groups. (1st measurement) 4 weeks after the interventions, in both groups. (2nd measurement) In total, time frame is 6 weeks.). 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 NCT06638203, which also lists 13 linked publications.
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 4 Feb 2025.