HealthyNCT05361096
The Effect of Flipped Learning Approach
A study testing Educational approach (Flipped learning) in people with Healthy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of flipped learning approach on nursing students' learning of patient safety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Educational approach (Flipped learning)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2021to 30 Jun 2021
- 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
- Enrolling in the Nursing Fundamentals II Course for the first time,
- Sufficient or unlimited internet access,
- Accepting to process the simultaneous lessons of patient safety on the Zoom platform,
- Being willing to participate in the research.
Who cannot join
- Having a high school, associate or undergraduate degree in a health-related field,
- To have taken a course on patient safety before.
- The student's desire to leave the research at any stage,
- Not filling in data collection forms.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Department of Health Sciences
Çankaya, Ankara, 06490
About this study
Official title: The Effect of Flipped Learning Approach on Nursing Students' Learning of Patient Safety: A Mixed Methods Study
This study was conducted to evaluate the effect of flipped learning approach on nursing students' learning of patient safety.
Read the detailed description
Patient safety is the basis of all theoretical and practical subjects in nursing. In the literature, while the traditional approach in nursing education has been stated to be insufficient in developing knowledge, attitudes and skills related to patient safety , the flipped learning approach is considered to be effective. During the out-of-class stage of the flipped learning approach, using the practices such as showing videos related patient safety, enriching course presentations and videos with interactive questions, organizing discussion sessions on forum pages and sharing educational games contribute to the students' following the subject more carefully. In the in-class stage, the use of activities such as case studies, group discussions, simulation, concept maps, various interactive methods and active participation of students in these activities is important. Teaching methods appealing to different learning styles and senses make it easier to look at the subject from different perspectives and establish a cause-effect relationship.
The evaluation of learning outcomes related to patient safety with the flipped learning approach is thought to provide guidance to nursing students and educators in terms of learning and teaching experiences.
The teaching of the patient safety subject was performed with the traditional educational to the control group (n=44) and with the flipped learning to the intervention group (n=45). Quantitative and quantitative data were collected with the "Demographic information form", "Achievement test", "Patient safety competency self-evaluation scale", and "Semi-structured focus group interview form". Quantitative data were collected before the applications, when the applications were completed, and six weeks after the applications. When the flipped learning approach was completed, qualitative data were collected.
- Conditions
- Healthy
- Being tested
- Educational approach (Flipped learning)
- Keywords
- nursing education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational approach (Flipped learning)Other
In the intervention group, the out-of-class stage started one week before the in-class stage of the relevant week. The researchers covered the topic of the week asynchronously in the virtual classroom in the learning management system. Students have been able to log into the system at anytime and anywhere and study the course video and other course materials repeatedly.
The in-class stage is the session in which the students in the intervention group come together with the researcher synchronously and conduct an online lesson. It was conducted one session per week for four weeks. The course was carried out synchronously on the Zoom platform during the in-class stage.
| Study group | Role | What they receive |
|---|---|---|
| Educational approach (Flipped learning) group | Experimental | The teaching of the patient safety subject was performed with the flipped learning to the intervention group (n=45). Receives: Other: Educational approach (Flipped learning) |
| Traditional education group | No intervention | The teaching of the patient safety subject was performed with the traditional educational to the control group (n=44). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of cognitive knowledge about patient safety
The achievement test prepared by the researchers according to the literature. It consists of 20 questions each with five options to measure the knowledge level for patient safety. These questions were on general knowledge (4 questions), identify patients correctly (2 questions), safe drug administration (6 questions), fall (5 questions), and infection (3 questions). An increase in the score from the test indicates a high level of knowledge about patient safety (min: 0 point, max: 100 point).
Measured: After the completion of the 4-week patient safety course, the achievement test (post-test) was administered to both groups immediately. After 6 weeks, the change in the knowledge level of the groups was measured again with the test (follow-up).
Development of patient safety competency
Patient Safety Competency Self-Evaluation Scale is a valid and reliable data collection scale. The scale, a five-point Likert type, has 36 items. It consists of three categories: knowledge, skills, and attitude. An increase in the score from the scale indicates an increase in competencies related to patient safety. (With a minimum potential score of 36 and a maximum score of 180). The Cronbach alpha coefficient was 0.95.
Measured: Patient Safety Competency Self-Evaluation Scale was applied immediately for both of the groups after the course, which lasted for 4 weeks, was completed. After 6 weeks, the change in the self-assesment of the groups was measured again with the scale.
Determining students' views on patient safety
The semi-structured focus group interview form was developed by the researchers. The researchers designed these questions on the basis of both their experiences and the literature. It consists of six open-ended questions in which students share their opinions on the flipped learning approach. Focus group discussions were conducted of students in the intervention group. A total of 25 students who volunteered to participate in the interviews were selected.
Measured: Immediately after flipped learning approach was completed, qualitative data were collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start10 Apr 2021
- Primary completion15 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Explanatory sequential design, one of the mixed-method designs, was used.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Eyikara, Gazi University
- Investigators
- Evrim Eyikara, Principal investigator, Doctor Research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361096
- Sponsor's protocol ID
- GaziU-SBF-EE-01
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Flipped Learning Approach on Nursing Students' Learning of Patient Safety: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05361096
- Acronym / sponsor ID
- GaziU-SBF-EE-01
- Conditions
- Healthy
- Keywords
- nursing education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to evaluate the effect of flipped learning approach on nursing students' learning of patient safety.
Detailed description
Patient safety is the basis of all theoretical and practical subjects in nursing. In the literature, while the traditional approach in nursing education has been stated to be insufficient in developing knowledge, attitudes and skills related to patient safety , the flipped learning approach is considered to be effective. During the out-of-class stage of the flipped learning approach, using the practices such as showing videos related patient safety, enriching course presentations and videos with interactive questions, organizing discussion sessions on forum pages and sharing educational games contribute to the students' following the subject more carefully. In the in-class stage, the use of activities such as case studies, group discussions, simulation, concept maps, various interactive methods and active participation of students in these activities is important. Teaching methods appealing to different learning styles and senses make it easier to look at the subject from different perspectives and establish a cause-effect relationship.
The evaluation of learning outcomes related to patient safety with the flipped learning approach is thought to provide guidance to nursing students and educators in terms of learning and teaching experiences.
The teaching of the patient safety subject was performed with the traditional educational to the control group (n=44) and with the flipped learning to the intervention group (n=45). Quantitative and quantitative data were collected with the "Demographic information form", "Achievement test", "Patient safety competency self-evaluation scale", and "Semi-structured focus group interview form". Quantitative data were collected before the applications, when the applications were completed, and six weeks after the applications. When the flipped learning approach was completed, qualitative data were collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Explanatory sequential design, one of the mixed-method designs, was used.
| Arm | Type | Receives |
|---|---|---|
| Educational approach (Flipped learning) group | Experimental | Other: Educational approach (Flipped learning)The teaching of the patient safety subject was performed with the flipped learning to the intervention group (n=45). |
| Traditional education group | No intervention | –The teaching of the patient safety subject was performed with the traditional educational to the control group (n=44). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolling in the Nursing Fundamentals II Course for the first time,
- Sufficient or unlimited internet access,
- Accepting to process the simultaneous lessons of patient safety on the Zoom platform,
- Being willing to participate in the research.
Key exclusion criteria (4 listed)
- Having a high school, associate or undergraduate degree in a health-related field,
- To have taken a course on patient safety before.
- The student's desire to leave the research at any stage,
- Not filling in data collection forms.
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 |
|---|---|---|
| Educational approach (Flipped learning)In the intervention group, the out-of-class stage started one week before the in-class stage of the relevant week. The researchers covered the topic of the week asynchronously in the virtual classroom in the learning management system. Students have been able to log into the system at anytime and anywhere and study the course video and other course materials repeatedly. The in-class stage is the session in which the students in the intervention group come together with the researcher synchronously and conduct an online lesson. It was conducted one session per week for four weeks. The course was carried out synchronously on the Zoom platform during the in-class stage. | Other | Educational approach (Flipped learning) group |
Primary outcome
Development of cognitive knowledge about patient safety
Time frame: After the completion of the 4-week patient safety course, the achievement test (post-test) was administered to both groups immediately. After 6 weeks, the change in the knowledge level of the groups was measured again with the test (follow-up).
The achievement test prepared by the researchers according to the literature. It consists of 20 questions each with five options to measure the knowledge level for patient safety. These questions were on general knowledge (4 questions), identify patients correctly (2 questions), safe drug administration (6 questions), fall (5 questions), and infection (3 questions). An increase in the score from the test indicates a high level of knowledge about patient safety (min: 0 point, max: 100 point).
Development of patient safety competency
Time frame: Patient Safety Competency Self-Evaluation Scale was applied immediately for both of the groups after the course, which lasted for 4 weeks, was completed. After 6 weeks, the change in the self-assesment of the groups was measured again with the scale.
Patient Safety Competency Self-Evaluation Scale is a valid and reliable data collection scale. The scale, a five-point Likert type, has 36 items. It consists of three categories: knowledge, skills, and attitude. An increase in the score from the scale indicates an increase in competencies related to patient safety. (With a minimum potential score of 36 and a maximum score of 180). The Cronbach alpha coefficient was 0.95.
Determining students' views on patient safety
Time frame: Immediately after flipped learning approach was completed, qualitative data were collected.
The semi-structured focus group interview form was developed by the researchers. The researchers designed these questions on the basis of both their experiences and the literature. It consists of six open-ended questions in which students share their opinions on the flipped learning approach. Focus group discussions were conducted of students in the intervention group. A total of 25 students who volunteered to participate in the interviews were selected.
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 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Eyikara principal investigator
Doctor Research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational approach (Flipped learning) in people with Healthy, run by Gazi 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 4 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 May 2022. 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?
Development of cognitive knowledge about patient safety (time frame: After the completion of the 4-week patient safety course, the achievement test (post-test) was administered to both groups immediately. After 6 weeks, the change in the knowledge level of the groups was measured again with the test (follow-up).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.