Pressure InjuryNCT05946291
Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation
A study testing Pressure injury training and Simulated Manneqquin training in people with Pressure Injury, run by Tepecik Training and Research Hospital.
Trial summary
When the literature is examined, it is seen that the pressure injury knowledge and evaluation levels of nursing students are low. Today, innovative approaches have started to be introduced to nursing education in proportion to the development of technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Pressure injury training and Simulated Manneqquin training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 30 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer
- Intern nursing students
Who cannot join
- Students who have previously received Care Management lecture or wound care training
- Have come with a horizontal transfer
- Have graduated from health vocational high school
- Work in a hospital or other institution
- Do not volunteer
About this study
Official title: The Effect of Two Different Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation in Nursing Students: A Randomized Controlled Trial
When the literature is examined, it is seen that the pressure injury knowledge and evaluation levels of nursing students are low. Today, innovative approaches have started to be introduced to nursing education in proportion to the development of technology. Simulation applications are also seen as one of these innovative approaches. In our study, it is aimed to examine the effect of pressure injury training to be given using high-reality standardized patient use and a medium-reality simulation model on the knowledge and evaluation level of intern nursing students. Students (n = 250) will be assigned blindly to the experimental and control groups using a simple randomization method, and then pressure injury information and assessment trainings will be given to the experimental group with a medium-reality simulation model on a standardized patient for the control group for 4 weeks. After 2 weeks, the final test will be performed, and the data will be assigned to blind groups. It will be evaluated by the researcher.
Read the detailed description
According to the literature, it is seen that nursing students do not have sufficient knowledge about pressure injuries, and innovative applications are needed to improve their clinical skills. When the studies are examined, it is seen that the studies comparing standardized patient use and simulation application in pressure injury education for nursing students are very limited. In this context, it is seen that there is a need for studies in which the effectiveness of different simulation applications in learning pressure injury in nursing students is examined, and it is considered important to contribute to the literature with this study to be conducted. It is considered that the project has the potential to be published in internationally respected journals and presented at conferences. Due to the increase in the number of students in nursing education and the lack of clinical areas, it is extremely important to practice in reality-like environments. In addition, students are required to acquire nursing psychomotor skills before meeting with a real patient. In this study, it is aimed to examine the effect of pressure injury teaching performed with standardized patients and a medium-reality simulation model on the knowledge and evaluation levels of nursing students. In this context, the hypothesis of the study is:
H0: There is no difference between the knowledge and evaluation levels of pressure injury in nursing students of the teaching given using standardized patient and medium-reality simulation model applications. H1: There is a difference between the knowledge and evaluation levels of pressure injury in nursing students based on the teaching given using standardized patient and medium-reality simulation model applications. In this study, it is planned to provide two different types of simulation training aimed at improving the knowledge and evaluation levels of nursing students about pressure injuries. The use of simulation applications will increase the psychomotor skills of the student and increase the level of knowledge and evaluation without encountering the real patient. In addition, the standardized patient and medium-reality simulation model planned to be used in the study will provide many students with the opportunity to learn about pressure injuries without the need to train on patients in the hospital.
- Conditions
- Pressure Injury
- Being tested
- Pressure injury training, Simulated Manneqquin training
- Keywords
- pressure injury, nursing students, simulation, moulage
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure injury trainingOther
Pressure injury training with mulage application on a standardized patient
Simulated Manneqquin trainingOther
Pressure injury training with mulage application on a simulated manneqquin
| Study group | Role | What they receive |
|---|---|---|
| Standardized Patient Group | Experimental | Standardized Patient: A pressure wound similar to reality will be created with the application of mulage on a standardized patient. In accordance with the scenario of a patient with a pressure wound, students will perform pressure wound evaluation and maintenance on a standardized patient in a simulation laboratory. Following the simulation application, student groups of eight to ten individuals will participate in a debriefing session. Receives: Other: Pressure injury training |
| Simulated Manneqquin Group | Active comparator | Simulated Mannequin: A pressure wound similar to reality will be created with the simulated mannequin mulage application. In accordance with the same scenario used in the experimental group, pressure wound evaluation and maintenance will be performed on the simulated mannequin in the simulation laboratory. Following the simulation application, student groups of eight to ten individuals will participate in a debriefing session. Receives: Other: Simulated Manneqquin training |
What is being measured
The primary outcome is the main question the study is designed to answer.
As a result of the study, it is expected that there will be an change in the students' pressure injury knowledge level.
The Turkish version of the Pressure Ulcer Knowledge Assessment Tool-updated version (PUKAT 2.0)" was developed in 2022 as a tool to assess the level of knowledge of pressure ulcers among nurses. It is a 25-question measurement tool consisting of a total of 6 sub-dimensions, including etiology of pressure injury, classification and observation, risk assessment, nutrition, prevention of occurrence, and special patient groups, with 5 Likert-type options. It was reported to have valid and reliable psychometric properties, as indicated by a Cronbach's Alpha value of 0.72, and to be suitable for use in the evaluation of the level of knowledge regarding pressure injuries. The minimum and maximum values obtainable from the scale are 0 and 25, respectively. The higher the score, the higher the level of knowledge.
Measured: Before and two weeks following applications
As a result of the study, it is expected that there will be an change in the level of pressure injury assessment of students.
The Pressure Injury Staging Registration Form was developed by the researchers. This form consists of pressure injuries at different stages, a total of 25 of which were taken by a wound care nurse. The form and photos have been submitted to three expert suggestions and have taken their final shape in accordance with the suggestions received. 5 of the photos include stage 1, 5 of them stage 2, 5 of them stage 3, 5 of them stage 4, 3 of them are non-staged pressure injuries, and 2 of them are deep tissue injuries.
Measured: Before and two weeks following applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 May 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies 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
- The study is planned as a double-blind randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Principal investigator, Zilan BARAN, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946291
- Sponsor's protocol ID
- TepecikTRH NURSE
- Status last verified
- Apr 2024
- First submitted
- 17 May 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dalli OE, Yildirim Y, Caliskan G, Girgin NK. Reliability and validity of the Turkish version of pressure ulcer knowledge assessment tool-updated version (PUKAT 2.0). J Tissue Viability. 2022 Feb;31(1):52-57. doi: 10.1016/j.jtv.2021.08.001. Epub 2021 Aug 11.
PubMed 34429220Baran Z, Ayik C, Ozden D. Comparison of standardized patient and medium-fidelity simulation practices on nursing students' knowledge, staging, and satisfaction regarding pressure injuries: A randomized controlled trial. Nurse Educ Today. 2025 Aug;151:106735. doi: 10.1016/j.nedt.2025.106735. Epub 2025 Apr 2.
PubMed 40209560
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation in Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05946291
- Acronym / sponsor ID
- TepecikTRH NURSE
- Conditions
- Pressure Injury
- Keywords
- pressure injury, nursing students, simulation, moulage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When the literature is examined, it is seen that the pressure injury knowledge and evaluation levels of nursing students are low. Today, innovative approaches have started to be introduced to nursing education in proportion to the development of technology. Simulation applications are also seen as one of these innovative approaches. In our study, it is aimed to examine the effect of pressure injury training to be given using high-reality standardized patient use and a medium-reality simulation model on the knowledge and evaluation level of intern nursing students. Students (n = 250) will be assigned blindly to the experimental and control groups using a simple randomization method, and then pressure injury information and assessment trainings will be given to the experimental group with a medium-reality simulation model on a standardized patient for the control group for 4 weeks. After 2 weeks, the final test will be performed, and the data will be assigned to blind groups. It will be evaluated by the researcher.
Detailed description
According to the literature, it is seen that nursing students do not have sufficient knowledge about pressure injuries, and innovative applications are needed to improve their clinical skills. When the studies are examined, it is seen that the studies comparing standardized patient use and simulation application in pressure injury education for nursing students are very limited. In this context, it is seen that there is a need for studies in which the effectiveness of different simulation applications in learning pressure injury in nursing students is examined, and it is considered important to contribute to the literature with this study to be conducted. It is considered that the project has the potential to be published in internationally respected journals and presented at conferences. Due to the increase in the number of students in nursing education and the lack of clinical areas, it is extremely important to practice in reality-like environments. In addition, students are required to acquire nursing psychomotor skills before meeting with a real patient. In this study, it is aimed to examine the effect of pressure injury teaching performed with standardized patients and a medium-reality simulation model on the knowledge and evaluation levels of nursing students. In this context, the hypothesis of the study is:
H0: There is no difference between the knowledge and evaluation levels of pressure injury in nursing students of the teaching given using standardized patient and medium-reality simulation model applications. H1: There is a difference between the knowledge and evaluation levels of pressure injury in nursing students based on the teaching given using standardized patient and medium-reality simulation model applications. In this study, it is planned to provide two different types of simulation training aimed at improving the knowledge and evaluation levels of nursing students about pressure injuries. The use of simulation applications will increase the psychomotor skills of the student and increase the level of knowledge and evaluation without encountering the real patient. In addition, the standardized patient and medium-reality simulation model planned to be used in the study will provide many students with the opportunity to learn about pressure injuries without the need to train on patients in the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is planned as a double-blind randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Group | Experimental | Other: Pressure injury trainingStandardized Patient: A pressure wound similar to reality will be created with the application of mulage on a standardized patient. In accordance with the scenario of a patient with a pressure wound, students will perform pressure wound evaluation and maintenance on a standardized patient in a simulation laboratory. Following the simulation application, student groups of eight to ten individuals will participate in a debriefing session. |
| Simulated Manneqquin Group | Active comparator | Other: Simulated Manneqquin trainingSimulated Mannequin: A pressure wound similar to reality will be created with the simulated mannequin mulage application. In accordance with the same scenario used in the experimental group, pressure wound evaluation and maintenance will be performed on the simulated mannequin in the simulation laboratory. Following the simulation application, student groups of eight to ten individuals will participate in a debriefing session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteer
- Intern nursing students
Key exclusion criteria (5 listed)
- Students who have previously received Care Management lecture or wound care training
- Have come with a horizontal transfer
- Have graduated from health vocational high school
- Work in a hospital or other institution
- Do not volunteer
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 |
|---|---|---|
| Pressure injury trainingPressure injury training with mulage application on a standardized patient | Other | Standardized Patient Group |
| Simulated Manneqquin trainingPressure injury training with mulage application on a simulated manneqquin | Other | Simulated Manneqquin Group |
Primary outcome
As a result of the study, it is expected that there will be an change in the students' pressure injury knowledge level.
Time frame: Before and two weeks following applications
The Turkish version of the Pressure Ulcer Knowledge Assessment Tool-updated version (PUKAT 2.0)" was developed in 2022 as a tool to assess the level of knowledge of pressure ulcers among nurses. It is a 25-question measurement tool consisting of a total of 6 sub-dimensions, including etiology of pressure injury, classification and observation, risk assessment, nutrition, prevention of occurrence, and special patient groups, with 5 Likert-type options. It was reported to have valid and reliable psychometric properties, as indicated by a Cronbach's Alpha value of 0.72, and to be suitable for use in the evaluation of the level of knowledge regarding pressure injuries. The minimum and maximum values obtainable from the scale are 0 and 25, respectively. The higher the score, the higher the level of knowledge.
As a result of the study, it is expected that there will be an change in the level of pressure injury assessment of students.
Time frame: Before and two weeks following applications
The Pressure Injury Staging Registration Form was developed by the researchers. This form consists of pressure injuries at different stages, a total of 25 of which were taken by a wound care nurse. The form and photos have been submitted to three expert suggestions and have taken their final shape in accordance with the suggestions received. 5 of the photos include stage 1, 5 of them stage 2, 5 of them stage 3, 5 of them stage 4, 3 of them are non-staged pressure injuries, and 2 of them are deep tissue injuries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 34429220Dalli OE, Yildirim Y, Caliskan G, Girgin NK. Reliability and validity of the Turkish version of pressure ulcer knowledge assessment tool-updated version (PUKAT 2.0). J Tissue Viability. 2022 Feb;31(1):52-57. doi: 10.1016/j.jtv.2021.08.001. Epub 2021 Aug 11.
- Derived from this study: PubMed 40209560Baran Z, Ayik C, Ozden D. Comparison of standardized patient and medium-fidelity simulation practices on nursing students' knowledge, staging, and satisfaction regarding pressure injuries: A randomized controlled trial. Nurse Educ Today. 2025 Aug;151:106735. doi: 10.1016/j.nedt.2025.106735. Epub 2025 Apr 2.
- Individual participant dataSharing planned: Yes
Related trials for Pressure Injury
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
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.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure injury training and Simulated Manneqquin training in people with Pressure Injury, run by Tepecik Training and Research Hospital.
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 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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?
As a result of the study, it is expected that there will be an change in the students' pressure injury knowledge level. (time frame: Before and two weeks following applications). 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 NCT05946291, which also lists 2 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 15 Apr 2024.