Pressure UlcerNCT05354687
Comparison of Self Directed Learning and Small Group Teaching Methods on Pressure Injury Assessment
A study testing Small-group Teaching and Self-directed Learning in people with Pressure Ulcer, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effect of pressure injury assessment training given by self-directed learning and small-group teaching methods on the knowledge and skill levels of nursing students: a three-group, pre-test - post-test, randomized controlled, parallel-group experimental study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Small-group Teaching and Self-directed Learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 17 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be registered for the Nursing Vocational Application Course
- Volunteering to participate in the research
- Having a mobile device (smartphone, tablet PC etc.)
Who cannot join
- To have received training on the evaluation of pressure injuries other than the basic nursing education
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pressure Injury Assessment Training Given by Self-directed Learning and Small Group Teaching Methods on Nursing Students' Knowledge and Skill Levels
The purpose of this study is to determine the effect of pressure injury assessment training given by self-directed learning and small-group teaching methods on the knowledge and skill levels of nursing students: a three-group, pre-test - post-test, randomized controlled, parallel-group experimental study.
Read the detailed description
Pressure injury is a common health problem worldwide. The global prevalence of hospital-associated pressure injuries was 8.4%. Regular wound assessment is required to determine appropriate treatment methods, monitor wound healing, and identify complications early in the pressure injury treatment process in order to achieve clinical goals.
According to the literature, nurses and nursing students have a low level of knowledge about pressure injury and there is a knowledge gap between nurses' knowledge of pressure injury and pressure injury practices. As a result, it is necessary to teach skills so that they can put their knowledge into practice. Individuals born after 2000, referred to as Generation Z, make up the majority of students beginning undergraduate education today. The most significant difference between Generation Z and other generations is that they were born during a period when digital high technology was widely used. This generation, also known as the "Internet generation," is constantly surrounded by new technological opportunities, communication, and transportation facilities. Because of these characteristics, it is critical to use teaching methods that will appeal to them when educating students in this group.
In a classroom, there are fast and slow learners. The amount of time allotted to students naturally decreases as the number of students in the class grows. Furthermore, student differences prevent the entire class from learning at the same time. Some students do not learn right away, others later, and still others do not learn at all in such a classroom. Education should be personalized in order to eliminate all of these non-occurrences.With the widespread use of smart phones today, mobile learning has become commonplace. Students gain clinical practice skills and experience when mobile technology is used as a support tool in nursing education practices.
For this purpose, the trainings to be given with the mobile application in this study will be supported by the activities in which the students can practice individually in the skill laboratory.
- Conditions
- Pressure Ulcer
- Being tested
- Small-group Teaching, Self-directed Learning
- Keywords
- pressure ulcer, self-directed learning, small-group learning, pressure injury, pressure injury assessment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-group TeachingOther
The Small-group Teaching will include theoretical lectures and laboratory practice. Theoretical training will be given in 2 hours and will last 2 week. After the theoretical training, laboratory practice will be made with mannequins, pressure injury models and photographs in the nursing skills laboratory. Laboratory practices will be done in groups of about 10 students. Laboratory application will take 1 week.
Self-directed LearningOther
The training will be given in two stages. The first stage of the training will be given via the mobile application for 2 weeks. Students will be able to access the training individually, wherever and whenever they want, via the mobile application. In the second stage, students will individually conduct laboratory practice. Students who start using the mobile application will make laboratory applications individually, whenever they want when the laboratory is available. Models and materials that students will need will be available in the laboratory. They will be able to get help from the trainer when they need it. Individual laboratory application will take 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be given to participants. Students will be given pre-test and post-tests. |
| Small-group Teaching Group | Experimental | Participants will be given training on the evaluation of pressure injuries with small-group teaching techniques. Receives: Other: Small-group Teaching |
| Self-directed Learning Group | Experimental | Participants will be given training on the evaluation of pressure injuries with self-directed learning technique. Receives: Other: Self-directed Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pressure Injuries Knowledge Test
The knowledge test was developed by the researchers in line with the literature. Learning objectives on the assessment of pressure injuries were determined and a table of specifications was prepared. A total of 34 questions were prepared, with at least 3 questions for each learning objective. For the knowledge test created, expert opinions were obtained from 6 faculty members in the field of nursing principles and 3 certified ostomy and wound care nurses. Within the scope of the research, the knowledge test will be applied to at least 100 3rd year nursing students and the item difficulty and discrimination indexes will be examined. If necessary, questions will be revised or removed from the test.
Measured: five weeks
Pressure Injury Evaluation Form
The pressure injury evaluation form was developed by researchers based on the "Wound diagnosis evaluation and follow-up form" of the Wound Ostomy Incontinence Nurses Association and pressure injury staging form developed by National Pressure Injury Advisory Panel (NPIAP). The form, which includes the staging and evaluation of pressure injury, consists of the subheadings of the wound bed and the wound periphery. The expert opinion of the form was obtained from three faculty members who are experts in the Department of Nursing Fundamentals and two specialist nurses who are actively working as wound care nurses, who have a Stoma and Wound Care Certificate approved by the Ministry of Health. This form will be used in the assessment of pressure injuries skills assessment.
Measured: five weeks
Secondary outcomes (1)
Pressure Injuries Assessment Education Evaluation Form
In this form, students express their opinions about the Evaluation of Pressure Injuries training and mobile application. The section on the Evaluation of Pressure Injuries training consists of open-ended questions. The other section is a 5-point Likert-type section with 19 statements about the mobile application. Positive statements are items 1, 3, 5, 6, 8, 10, 11, 13, 14, 16, 17, and 19, while negative statements are items 2, 4, 7, 9, 12, 15, and 18. Each item on the form is scored separately. Each item is worth a minimum of one point and a maximum of five points. Higher scores for positive items mean better outcome, and higher scores for negative items mean worse outcome.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start9 May 2022
- Primary completion10 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a three-group, pre-test - post-test, randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Aydoğan, Gazi University
- Investigators
- Nurcan Çalışkan, Professor, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354687
- Sponsor's protocol ID
- GaziU-SBF-SA-1
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sezgünsay, E. Hemşirelik öğrencilerinin basınç yaralanması değerlendirme becerilerinin geliştirilmesinde yüksek gerçeklikli simülasyon yönteminin etkinliğinin incelenmesi, 2019 (Master's thesis, Gülhane Sağlık Bilimleri Enstitüsü).
Gurdap Z, Cengiz Z. Teach-back versus video-assisted instruction for improving nursing students' knowledge, self-efficacy and skills in safe medical device use. Ir J Med Sci. 2026 Sep 24. doi: 10.1007/s11845-026-04640-4. Online ahead of print.
PubMed 42782585Aydogan S, Caliskan N. The effect of self-directed learning via a smartphone application and small-group teaching on nursing students' learning of pressure injury assessment: A randomized controlled study. Nurse Educ Pract. 2025 May;85:104336. doi: 10.1016/j.nepr.2025.104336. Epub 2025 Mar 27.
PubMed 40187051
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Injury Assessment Training Given by Self-directed Learning and Small Group Teaching Methods on Nursing Students' Knowledge and Skill Levels
- ClinicalTrials.gov ID
- NCT05354687
- Acronym / sponsor ID
- GaziU-SBF-SA-1
- Conditions
- Pressure Ulcer
- Keywords
- pressure ulcer, self-directed learning, small-group learning, pressure injury, pressure injury assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 29 Apr 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.
The purpose of this study is to determine the effect of pressure injury assessment training given by self-directed learning and small-group teaching methods on the knowledge and skill levels of nursing students: a three-group, pre-test - post-test, randomized controlled, parallel-group experimental study.
Detailed description
Pressure injury is a common health problem worldwide. The global prevalence of hospital-associated pressure injuries was 8.4%. Regular wound assessment is required to determine appropriate treatment methods, monitor wound healing, and identify complications early in the pressure injury treatment process in order to achieve clinical goals.
According to the literature, nurses and nursing students have a low level of knowledge about pressure injury and there is a knowledge gap between nurses' knowledge of pressure injury and pressure injury practices. As a result, it is necessary to teach skills so that they can put their knowledge into practice. Individuals born after 2000, referred to as Generation Z, make up the majority of students beginning undergraduate education today. The most significant difference between Generation Z and other generations is that they were born during a period when digital high technology was widely used. This generation, also known as the "Internet generation," is constantly surrounded by new technological opportunities, communication, and transportation facilities. Because of these characteristics, it is critical to use teaching methods that will appeal to them when educating students in this group.
In a classroom, there are fast and slow learners. The amount of time allotted to students naturally decreases as the number of students in the class grows. Furthermore, student differences prevent the entire class from learning at the same time. Some students do not learn right away, others later, and still others do not learn at all in such a classroom. Education should be personalized in order to eliminate all of these non-occurrences.With the widespread use of smart phones today, mobile learning has become commonplace. Students gain clinical practice skills and experience when mobile technology is used as a support tool in nursing education practices.
For this purpose, the trainings to be given with the mobile application in this study will be supported by the activities in which the students can practice individually in the skill laboratory.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- a three-group, pre-test - post-test, randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be given to participants. Students will be given pre-test and post-tests. |
| Small-group Teaching Group | Experimental | Other: Small-group TeachingParticipants will be given training on the evaluation of pressure injuries with small-group teaching techniques. |
| Self-directed Learning Group | Experimental | Other: Self-directed LearningParticipants will be given training on the evaluation of pressure injuries with self-directed learning technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be registered for the Nursing Vocational Application Course
- Volunteering to participate in the research
- Having a mobile device (smartphone, tablet PC etc.)
Key exclusion criteria (1 listed)
- To have received training on the evaluation of pressure injuries other than the basic nursing education
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 |
|---|---|---|
| Small-group TeachingThe Small-group Teaching will include theoretical lectures and laboratory practice. Theoretical training will be given in 2 hours and will last 2 week. After the theoretical training, laboratory practice will be made with mannequins, pressure injury models and photographs in the nursing skills laboratory. Laboratory practices will be done in groups of about 10 students. Laboratory application will take 1 week. | Other | Small-group Teaching Group |
| Self-directed LearningThe training will be given in two stages. The first stage of the training will be given via the mobile application for 2 weeks. Students will be able to access the training individually, wherever and whenever they want, via the mobile application. In the second stage, students will individually conduct laboratory practice. Students who start using the mobile application will make laboratory applications individually, whenever they want when the laboratory is available. Models and materials that students will need will be available in the laboratory. They will be able to get help from the trainer when they need it. Individual laboratory application will take 1 week. | Other | Self-directed Learning Group |
Primary outcome
Evaluation of Pressure Injuries Knowledge Test
Time frame: five weeks
The knowledge test was developed by the researchers in line with the literature. Learning objectives on the assessment of pressure injuries were determined and a table of specifications was prepared. A total of 34 questions were prepared, with at least 3 questions for each learning objective. For the knowledge test created, expert opinions were obtained from 6 faculty members in the field of nursing principles and 3 certified ostomy and wound care nurses. Within the scope of the research, the knowledge test will be applied to at least 100 3rd year nursing students and the item difficulty and discrimination indexes will be examined. If necessary, questions will be revised or removed from the test.
Pressure Injury Evaluation Form
Time frame: five weeks
The pressure injury evaluation form was developed by researchers based on the "Wound diagnosis evaluation and follow-up form" of the Wound Ostomy Incontinence Nurses Association and pressure injury staging form developed by National Pressure Injury Advisory Panel (NPIAP). The form, which includes the staging and evaluation of pressure injury, consists of the subheadings of the wound bed and the wound periphery. The expert opinion of the form was obtained from three faculty members who are experts in the Department of Nursing Fundamentals and two specialist nurses who are actively working as wound care nurses, who have a Stoma and Wound Care Certificate approved by the Ministry of Health. This form will be used in the assessment of pressure injuries skills assessment.
1 secondary outcome
Pressure Injuries Assessment Education Evaluation Form
Time frame: 1 week
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 17 Jan 2023.
- BackgroundSezgünsay, E. Hemşirelik öğrencilerinin basınç yaralanması değerlendirme becerilerinin geliştirilmesinde yüksek gerçeklikli simülasyon yönteminin etkinliğinin incelenmesi, 2019 (Master's thesis, Gülhane Sağlık Bilimleri Enstitüsü).
- Derived from this study: PubMed 42782585Gurdap Z, Cengiz Z. Teach-back versus video-assisted instruction for improving nursing students' knowledge, self-efficacy and skills in safe medical device use. Ir J Med Sci. 2026 Sep 24. doi: 10.1007/s11845-026-04640-4. Online ahead of print.
- Derived from this study: PubMed 40187051Aydogan S, Caliskan N. The effect of self-directed learning via a smartphone application and small-group teaching on nursing students' learning of pressure injury assessment: A randomized controlled study. Nurse Educ Pract. 2025 May;85:104336. doi: 10.1016/j.nepr.2025.104336. Epub 2025 Mar 27.
- 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.
Nurcan Çalışkan, Professor principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small-group Teaching and Self-directed Learning in people with Pressure Ulcer, 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 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 17 Jan 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?
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?
Evaluation of Pressure Injuries Knowledge Test (time frame: five weeks). 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 NCT05354687, which also lists 3 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 17 Jan 2023.