PROBLEM-BASED LEARNINGNCT06971679
FLIPPED CLASSROOM METHODS COMBINED WITH PROBLEM-BASED LEARNING ON NURSING STUDENTS
A study testing Flipped Method in people with PROBLEM-BASED LEARNING and NURSING STUDENTS, run by Gülcan Karabulut at 1 site in Turkey (Türkiye).
Trial summary
Nurses need to develop critical thinking skills to be competent in flexible, personalized, and situation-specific problem solving in today's healthcare environment of rapid change and increasing information. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PROBLEM-BASED LEARNING, NURSING STUDENTS, FLIPPED CLASSROOM METHODS
- What is being tested?
- Flipped Method
- 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
- 7 Oct 2024to 20 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 2024-2025 Academic Year Fall Semester enrolled in the Nursing Management Lesson,
- agreed to participate in the study
- completed the data collection forms completely
Who cannot join
- want to leave the research at any time of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Kumluca Faculty of Health Science
Antalya
About this study
Official title: INVESTIGATING THE EFFECT OF FLIPPED CLASSROOM METHODS COMBINED WITH PROBLEM-BASED LEARNING ON NURSING STUDENTS' KNOWLEDGE AND ATTITUDES REGARDING PATIENT SAFETY
Nurses need to develop critical thinking skills to be competent in flexible, personalized, and situation-specific problem solving in today's healthcare environment of rapid change and increasing information. This means that nursing education should prepare nursing students to meet the needs of patients, serve as leaders, develop scientific rigor for the benefit of patients, and make decisions based on critical thinking. In addition to transferring theoretical knowledge, nursing education is also very important in terms of putting students' knowledge into practice and improving students' comprehensive qualifications.
Read the detailed description
One of these qualities is the fundamental responsibility of nurses to ensure patient safety. It is estimated that 421 million hospitalizations occur every year in the world. Approximately 7.42 million adverse events occur during these hospitalizations, and patient harm is the 14th leading cause of global mortality. Many universities are looking for teaching methods that can improve students' clinical decision-making abilities and self-directed learning in order to provide safe and quality nursing care. Lack of patient safety knowledge is one of the educational problems of nursing students leading to unsafe practices.Early education on patient safety is crucial in preparing nurses to be competent in patient care. Therefore, offering patient safety education courses at the undergraduate level using an innovative approach is important to improve patient safety and quality in nursing care.
Various innovative approaches are used in nursing education to improve students' critical thinking and problem-solving skills. These include team-based learning, concept mapping, case studies and problem-based learning (PBL) and flipped classroom model. In the flipped classroom model, students are presented with course materials prior to class and then class time is spent gaining in-depth understanding through interactive activities. Studies have shown that the flipped classroom model improves students' academic performance and satisfaction. However, compared to traditional lecture-based classes, reverse classes have been reported to be more effective in improving academic performance and course evaluation as well as developing engagement and higher-order thinking skills in nursing students. Problem-based learning (PBL), one of the important teaching methods that improve nursing students' clinical performance and critical thinking skills, can be used as an in-class activity in flipped classrooms. However, some studies indicate that the simple implementation of PBL instruction can challenge students' systematic understanding of the required knowledge and that this model is more difficult for students with low learning ability and performance, resulting in learning fatigue and worse learning outcomes than expected. Several studies have explored the combined use of reverse classrooms and PBL in nursing education. However, it is important to investigate how to maximize the impact of pre-course self-study to promote the development of students' abilities. Therefore, this study aims to determine the effect of patient safety education provided by combining the flipped classroom model with problem-based learning within the scope of nursing management course on nursing students' patient safety knowledge, attitudes and perceptions.
- Being tested
- Flipped Method
- Keywords
- Problem-based learning, Nursing students, Flipped Classroom Methods, Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flipped MethodBehavioural
In the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Didactic Group | No intervention | In the first week of the clinical practice, the control group students were given patient safety training by the researcher using the classical didactic method on the same day and time as the intervention group students. After the training, a case test was applied to the students. |
| Flipped Group | Experimental | In the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes. Receives: Behavioral: Flipped Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic Characteristics Form
The socio-demographic characteristics form prepared by the researchers consisted of four questions: age, gender, the status of receiving training on medical errors and patient safety outside the curriculum, and the source of the training.
Measured: Baseline
H-PEPSS TR
The H-PEPSS TR is a 23-item, two-level measurement tool. It consists of two main dimensions: "Classroom" and "Clinical environment". The scale consists of six sub-dimensions. Item total score averages are used in the whole scale and sub-dimensions. Each item of the scale is evaluated as "Strongly disagree-1 point" and "Strongly agree-5 points" on a five-point. The higher the score obtained from the "classroom" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety knowledge developed in the classroom environment.The higher the score obtained from the "clinical environment" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety competence developed in the clinical environment.
Measured: Baseline and 4 weeks after the intervention
Patient Safety Competency Self-Assessment Tool
Item total score averages are used in the total scale and sub-dimensions. The minimum score that can be obtained from the scale and sub-dimensions is 1 and the maximum score is 5. Higher mean scores indicate that students have better knowledge, skills and attitudinal competencies in patient safety. Since the instrument is a multidimensional scale, the mean scores of the total scale, 3 dimensions and 12 factors are evaluated separately. Each item of the scale is evaluated in a five-point Likert scale with different expressions in each dimension; The knowledge dimension consists of 2 factors and 6 items in total. Its evaluation is as "1=I have no knowledge at all, 5=I know very well". The skills dimension consists of a total of 6 factors and 21 items. Its evaluation is as "1=I cannot do it at all, 5=I can do it very easily". Attitude dimension consists of 4 factors and 14 items. The evaluation is "1=Strongly disagree, 5=Strongly agree".
Measured: Baseline and 4 weeks after the intervention
Case Test and Open-Ended Question
A 20-question patient safety events test and two open-ended case questions (cause of error, risks, influencing factors, developing strategies for prevention, incident reporting and root causes) were created by the researchers and administered as a test. The test was evaluated out of 100 points.
This is an evalution test exam, the minimum point is 65 for success.
Measured: 4 weeks after the intervention
PBL Modules
Modules were prepared by the researchers. The cases and questions in the case test were structured as PBL cases to compare the module content assessments. In PBL modules, students were asked to conduct root cause analysis on reported medical error scenarios. In this analysis, module work including the cause of the error, risks, influencing factors, suggestions for prevention, extraction of the root causes of the event, etc. was carried out. In the evaluation of each group, points were given according to the 100-point system. Case test results were evaluated as correct answers. PBL cases were scored on the realization of the implementation steps.
This is an evaluation exam and 65 point for be success.
Measured: 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start7 Oct 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROBLEM-BASED LEARNINGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülcan Karabulut
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor-investigator, Gülcan Karabulut, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971679
- Sponsor's protocol ID
- TBAEK-701
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATING THE EFFECT OF FLIPPED CLASSROOM METHODS COMBINED WITH PROBLEM-BASED LEARNING ON NURSING STUDENTS' KNOWLEDGE AND ATTITUDES REGARDING PATIENT SAFETY
- ClinicalTrials.gov ID
- NCT06971679
- Acronym / sponsor ID
- TBAEK-701
- Keywords
- Problem-based learning, Nursing students, Flipped Classroom Methods, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gülcan KarabulutUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 14 May 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.
Nurses need to develop critical thinking skills to be competent in flexible, personalized, and situation-specific problem solving in today's healthcare environment of rapid change and increasing information. This means that nursing education should prepare nursing students to meet the needs of patients, serve as leaders, develop scientific rigor for the benefit of patients, and make decisions based on critical thinking. In addition to transferring theoretical knowledge, nursing education is also very important in terms of putting students' knowledge into practice and improving students' comprehensive qualifications.
Detailed description
One of these qualities is the fundamental responsibility of nurses to ensure patient safety. It is estimated that 421 million hospitalizations occur every year in the world. Approximately 7.42 million adverse events occur during these hospitalizations, and patient harm is the 14th leading cause of global mortality. Many universities are looking for teaching methods that can improve students' clinical decision-making abilities and self-directed learning in order to provide safe and quality nursing care. Lack of patient safety knowledge is one of the educational problems of nursing students leading to unsafe practices.Early education on patient safety is crucial in preparing nurses to be competent in patient care. Therefore, offering patient safety education courses at the undergraduate level using an innovative approach is important to improve patient safety and quality in nursing care.
Various innovative approaches are used in nursing education to improve students' critical thinking and problem-solving skills. These include team-based learning, concept mapping, case studies and problem-based learning (PBL) and flipped classroom model. In the flipped classroom model, students are presented with course materials prior to class and then class time is spent gaining in-depth understanding through interactive activities. Studies have shown that the flipped classroom model improves students' academic performance and satisfaction. However, compared to traditional lecture-based classes, reverse classes have been reported to be more effective in improving academic performance and course evaluation as well as developing engagement and higher-order thinking skills in nursing students. Problem-based learning (PBL), one of the important teaching methods that improve nursing students' clinical performance and critical thinking skills, can be used as an in-class activity in flipped classrooms. However, some studies indicate that the simple implementation of PBL instruction can challenge students' systematic understanding of the required knowledge and that this model is more difficult for students with low learning ability and performance, resulting in learning fatigue and worse learning outcomes than expected. Several studies have explored the combined use of reverse classrooms and PBL in nursing education. However, it is important to investigate how to maximize the impact of pre-course self-study to promote the development of students' abilities. Therefore, this study aims to determine the effect of patient safety education provided by combining the flipped classroom model with problem-based learning within the scope of nursing management course on nursing students' patient safety knowledge, attitudes and perceptions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Didactic Group | No intervention | –In the first week of the clinical practice, the control group students were given patient safety training by the researcher using the classical didactic method on the same day and time as the intervention group students. After the training, a case test was applied to the students. |
| Flipped Group | Experimental | Behavioral: Flipped MethodIn the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 2024-2025 Academic Year Fall Semester enrolled in the Nursing Management Lesson,
- agreed to participate in the study
- completed the data collection forms completely
Key exclusion criteria (1 listed)
- want to leave the research at any time of 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 |
|---|---|---|
| Flipped MethodIn the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes. | Behavioural | Flipped Group |
Primary outcome
Socio-demographic Characteristics Form
Time frame: Baseline
The socio-demographic characteristics form prepared by the researchers consisted of four questions: age, gender, the status of receiving training on medical errors and patient safety outside the curriculum, and the source of the training.
H-PEPSS TR
Time frame: Baseline and 4 weeks after the intervention
The H-PEPSS TR is a 23-item, two-level measurement tool. It consists of two main dimensions: "Classroom" and "Clinical environment". The scale consists of six sub-dimensions. Item total score averages are used in the whole scale and sub-dimensions. Each item of the scale is evaluated as "Strongly disagree-1 point" and "Strongly agree-5 points" on a five-point. The higher the score obtained from the "classroom" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety knowledge developed in the classroom environment.The higher the score obtained from the "clinical environment" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety competence developed in the clinical environment.
Patient Safety Competency Self-Assessment Tool
Time frame: Baseline and 4 weeks after the intervention
Item total score averages are used in the total scale and sub-dimensions. The minimum score that can be obtained from the scale and sub-dimensions is 1 and the maximum score is 5. Higher mean scores indicate that students have better knowledge, skills and attitudinal competencies in patient safety. Since the instrument is a multidimensional scale, the mean scores of the total scale, 3 dimensions and 12 factors are evaluated separately. Each item of the scale is evaluated in a five-point Likert scale with different expressions in each dimension; The knowledge dimension consists of 2 factors and 6 items in total. Its evaluation is as "1=I have no knowledge at all, 5=I know very well". The skills dimension consists of a total of 6 factors and 21 items. Its evaluation is as "1=I cannot do it at all, 5=I can do it very easily". Attitude dimension consists of 4 factors and 14 items. The evaluation is "1=Strongly disagree, 5=Strongly agree".
Case Test and Open-Ended Question
Time frame: 4 weeks after the intervention
A 20-question patient safety events test and two open-ended case questions (cause of error, risks, influencing factors, developing strategies for prevention, incident reporting and root causes) were created by the researchers and administered as a test. The test was evaluated out of 100 points. This is an evalution test exam, the minimum point is 65 for success.
PBL Modules
Time frame: 4 weeks after the intervention
Modules were prepared by the researchers. The cases and questions in the case test were structured as PBL cases to compare the module content assessments. In PBL modules, students were asked to conduct root cause analysis on reported medical error scenarios. In this analysis, module work including the cause of the error, risks, influencing factors, suggestions for prevention, extraction of the root causes of the event, etc. was carried out. In the evaluation of each group, points were given according to the 100-point system. Case test results were evaluated as correct answers. PBL cases were scored on the realization of the implementation steps. This is an evaluation exam and 65 point for be success.
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Flipped Method in people with PROBLEM-BASED LEARNING and NURSING STUDENTS, run by Gülcan Karabulut 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 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 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?
Socio-demographic Characteristics Form (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.