Pressure InjuryNCT06406504
Improving Pressure Injury Classification and Assessment Skills: In Situ Simulation and Moulage
A study testing in-laboratory simulation group and in-situ simulation group in people with Pressure Injury, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effectiveness of in-situ simulation and moulage to improve nursing students' pressure injury classification and assessment skills. A randomized controlled model with a pretest-posttest control group was used in this study. Read more about this study
- Who is it for?
- Ages 22 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- in-laboratory simulation group and in-situ simulation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 22 Jun 2023
- 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 22 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Senior nursing students
- Nursing students who had not previously performed classification and assessment of PI
- Nursing students who volunteered to participate were included in the study
Who cannot join
- Nursing students who had previously performed classification and assessment of PI
- Nursing students who do not attend simulation training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Realistic Experience in Improving Pressure Injury Classification and Assessment Skills: In Situ Simulation and Moulage
The aim of this study was to evaluate the effectiveness of in-situ simulation and moulage to improve nursing students' pressure injury classification and assessment skills. A randomized controlled model with a pretest-posttest control group was used in this study. The population of the study consists of a faculty of nursing at a state university. The sample consisted of 84 nursing students. The control group received simulation-based training using a pressure injury simulator on a standardised patient in the simulation laboratory, the in-laboratory simulation group received simulation-based training using moulage on a standardised patient in the simulation laboratory, and the in-situ simulation group received simulation-based training using moulage on a standardised patient in the clinic of a university hospital. The research data were collected by Descriptive Characteristics Form, Pressure Injury Knowledge Test, Pressure Injury Assessment Form, Performance Checklist, Students' Satisfaction and Self-Confidence Scale and Student Feedback Form.
Read the detailed description
In this study, the reality of the environment was increased with the in-site simulation method, the physical reality was increased by ensuring that the standardised patient characteristics match with the patient characteristics in the real world with moulage, and the functional reality was increased by performing a wound classification and evaluation similar to the real wound with moulage. In this context, this study was conducted to determine the effect of in-situ simulation and moulage application in order to improve nursing students' skills in Pressure Injury (PI) classification and assessment.
For this purpose, there are three hypotheses guiding the research:
There will be a difference between the PI knowledge test scores of the groups. There will be a difference between the groups' ability to classification and assessment PI.
There will be a difference between the satisfaction and self-confidence levels of the groups.
This study was structured as a randomized, controlled experimental investigation with pretest and posttest control groups. It was conducted to evaluate the effectiveness of in situ simulation and moulage to improve nursing students' PI classification and evaluation skills. It was conducted at a nursing school in Turkey between September 2021 and May 2023. Simulation-based experiences were designed based on the INACSL Healthcare Simulation Standards of Best PracticeTM Simulation Design. The study design was reported following the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).
The study population comprised senior nursing students (N=284). The sample size was calculated on the basis of previous studies evaluating the effectiveness of the moulage method in PI assessment skills. Based on the power analysis, the study's sample size was determined to be 84 (ɑ=0.10, 1-β=0.95) with 95% power and ɑ=0.10 error (90% confidence interval). Taking into account possible losses during the study, 90 students were included. Senior nursing students who had not previously performed classification and assessment of PI, who had not attended any course related to PI, and who volunteered to participate were included in the study. In order to ensure homogeneous distribution of students in terms of academic achievement score, a statistician who was not involved in the study randomised the students according to their grade point averages at the end of the third year using a website. The simulation practices of the students in the control group (n=30) were performed with a PI simulator on a standardised patient in the simulation laboratory, the simulation practices of the students in the simulation in-laboratory group (n=30) were performed with moulage application on a standardised patient in the simulation laboratory, and the simulation practices of the students in the in-situ simulation group (n=30) were performed with moulage application on a standardised patient in a clinic of a university hospital. Since two students from each of the three groups left the study, the study was completed with 84 students.
- Conditions
- Pressure Injury
- Being tested
- in-laboratory simulation group, in-situ simulation group
- Keywords
- In-situ simulation, simulation-based training, moulage, pressure injury, nursing students
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-laboratory simulation groupOther
The students in-laboratory group performed the simulation applications in the patient room in the simulation laboratory. One of the Stage 2 and one of the Stage 3 PI was created by the researcher with moulage to the heel and lateral malleolus area of the standardised patient taken to the patient room.
in-situ simulation groupOther
Students in the in-situ simulation group performed the simulation practices in a patient room in a clinic at a university hospital. One of the Stage 2 and one of the Stage 3 PI was created by the researcher with moulage to the heel and lateral malleolus area of the standardised patient taken to the patient room.
| Study group | Role | What they receive |
|---|---|---|
| in-laboratory simulation group | Experimental | The simulation practices of the students in the simulation practices of the students in the simulation in-laboratory simulation group (n=30) were performed with moulage application on a standardised patient in the simulation laboratory Receives: Other: in-laboratory simulation group |
| in-situ simulation group | Experimental | The simulation practices of the students in the simulation practices of the students in the in-situ simulation group (n=30) were performed with moulage application on a standardised patient in a clinic of a university hospital. Receives: Other: in-situ simulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Injury Skill
This form was prepared by the researcher based on the literature. The form consists of twenty-five items and the stages of the PI assessment. The student's performance was scored as "correctly applied" (2 points), "partially applied" (1 point), "not applied" and "incorrectly applied" (0 points). The student can get a maximum score of 50 and a minimum score of 0. The form was evaluated by the same experts.
Measured: four week
Secondary outcomes (2)
Pressure Injury Knowledge
The questionnaire was prepared by the researcher based on the literature. The PI knowledge test consists of 15 multiple-choice questions on PI general knowledge (5 questions), classification (7 questions) and PI assessment (3 questions). The highest score is 100 and the lowest score is 0. For the test, expert opinion was obtained from four faculty members, two of whom were faculty members working in the field of PI.
Measured: four week
Students' satisfaction and self-confidence scale
This scale is used to measure students' satisfaction and self-confidence in a simulation learning environment. It comprises two sub-dimensions: "Satisfaction with Current Learning" and "Self-confidence in Learning." Student responses for each item were recorded on a five-point Likert-type scale; Strongly Disagree, Disagree, Neutral, Agree and Strongly Agree. It was found that the Cronbach's Alpha value for "Satisfaction with current learning" was 0.85 and Cronbach's Alpha value for "Self-confidence in Learning" was 0.77. Scores range from 1 to 5; 1 is the lowest score and 5 points is the highest and as the total score increases, students' satisfaction and selfconfidence in learning increase, as well.
Measured: four week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Sep 2021
- Primary completion1 May 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 participants were randomly assigned to in-laboratory simulation group, in-situ simulation group, and control groups.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice ERDEM ÖNDER, Mehmet Akif Ersoy University
- Investigators
- Hatice ERDEM ONDER, Principal investigator, Mehmet Akif Ersoy UniversityDilek SARI, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406504
- Sponsor's protocol ID
- MehmetAkifU-SBF-HEÖ-01
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erdem Onder H, Sari D. Improving pressure injury assessment skills of nursing students' using in-situ simulation and moulage: a randomized controlled trial. BMC Nurs. 2025 Nov 6;24(1):1373. doi: 10.1186/s12912-025-04049-x.
PubMed 41199277
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Realistic Experience in Improving Pressure Injury Classification and Assessment Skills: In Situ Simulation and Moulage
- ClinicalTrials.gov ID
- NCT06406504
- Acronym / sponsor ID
- MehmetAkifU-SBF-HEÖ-01
- Conditions
- Pressure Injury
- Keywords
- In-situ simulation, simulation-based training, moulage, pressure injury, nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 9 May 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 study was to evaluate the effectiveness of in-situ simulation and moulage to improve nursing students' pressure injury classification and assessment skills. A randomized controlled model with a pretest-posttest control group was used in this study. The population of the study consists of a faculty of nursing at a state university. The sample consisted of 84 nursing students. The control group received simulation-based training using a pressure injury simulator on a standardised patient in the simulation laboratory, the in-laboratory simulation group received simulation-based training using moulage on a standardised patient in the simulation laboratory, and the in-situ simulation group received simulation-based training using moulage on a standardised patient in the clinic of a university hospital. The research data were collected by Descriptive Characteristics Form, Pressure Injury Knowledge Test, Pressure Injury Assessment Form, Performance Checklist, Students' Satisfaction and Self-Confidence Scale and Student Feedback Form.
Detailed description
In this study, the reality of the environment was increased with the in-site simulation method, the physical reality was increased by ensuring that the standardised patient characteristics match with the patient characteristics in the real world with moulage, and the functional reality was increased by performing a wound classification and evaluation similar to the real wound with moulage. In this context, this study was conducted to determine the effect of in-situ simulation and moulage application in order to improve nursing students' skills in Pressure Injury (PI) classification and assessment.
For this purpose, there are three hypotheses guiding the research:
There will be a difference between the PI knowledge test scores of the groups. There will be a difference between the groups' ability to classification and assessment PI.
There will be a difference between the satisfaction and self-confidence levels of the groups.
This study was structured as a randomized, controlled experimental investigation with pretest and posttest control groups. It was conducted to evaluate the effectiveness of in situ simulation and moulage to improve nursing students' PI classification and evaluation skills. It was conducted at a nursing school in Turkey between September 2021 and May 2023. Simulation-based experiences were designed based on the INACSL Healthcare Simulation Standards of Best PracticeTM Simulation Design. The study design was reported following the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).
The study population comprised senior nursing students (N=284). The sample size was calculated on the basis of previous studies evaluating the effectiveness of the moulage method in PI assessment skills. Based on the power analysis, the study's sample size was determined to be 84 (ɑ=0.10, 1-β=0.95) with 95% power and ɑ=0.10 error (90% confidence interval). Taking into account possible losses during the study, 90 students were included. Senior nursing students who had not previously performed classification and assessment of PI, who had not attended any course related to PI, and who volunteered to participate were included in the study. In order to ensure homogeneous distribution of students in terms of academic achievement score, a statistician who was not involved in the study randomised the students according to their grade point averages at the end of the third year using a website. The simulation practices of the students in the control group (n=30) were performed with a PI simulator on a standardised patient in the simulation laboratory, the simulation practices of the students in the simulation in-laboratory group (n=30) were performed with moulage application on a standardised patient in the simulation laboratory, and the simulation practices of the students in the in-situ simulation group (n=30) were performed with moulage application on a standardised patient in a clinic of a university hospital. Since two students from each of the three groups left the study, the study was completed with 84 students.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomly assigned to in-laboratory simulation group, in-situ simulation group, and control groups.
| Arm | Type | Receives |
|---|---|---|
| in-laboratory simulation group | Experimental | Other: in-laboratory simulation groupThe simulation practices of the students in the simulation practices of the students in the simulation in-laboratory simulation group (n=30) were performed with moulage application on a standardised patient in the simulation laboratory |
| in-situ simulation group | Experimental | Other: in-situ simulation groupThe simulation practices of the students in the simulation practices of the students in the in-situ simulation group (n=30) were performed with moulage application on a standardised patient in a clinic of a university hospital. |
Who may qualify
- Ages
- 22 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Senior nursing students
- Nursing students who had not previously performed classification and assessment of PI
- Nursing students who volunteered to participate were included in the study
Key exclusion criteria (2 listed)
- Nursing students who had previously performed classification and assessment of PI
- Nursing students who do not attend simulation training
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 |
|---|---|---|
| in-laboratory simulation groupThe students in-laboratory group performed the simulation applications in the patient room in the simulation laboratory. One of the Stage 2 and one of the Stage 3 PI was created by the researcher with moulage to the heel and lateral malleolus area of the standardised patient taken to the patient room. | Other | in-laboratory simulation group |
| in-situ simulation groupStudents in the in-situ simulation group performed the simulation practices in a patient room in a clinic at a university hospital. One of the Stage 2 and one of the Stage 3 PI was created by the researcher with moulage to the heel and lateral malleolus area of the standardised patient taken to the patient room. | Other | in-situ simulation group |
Primary outcome
Pressure Injury Skill
Time frame: four week
This form was prepared by the researcher based on the literature. The form consists of twenty-five items and the stages of the PI assessment. The student's performance was scored as "correctly applied" (2 points), "partially applied" (1 point), "not applied" and "incorrectly applied" (0 points). The student can get a maximum score of 50 and a minimum score of 0. The form was evaluated by the same experts.
2 secondary outcomes
Pressure Injury Knowledge
Time frame: four week
Students' satisfaction and self-confidence scale
Time frame: four 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 May 2024.
- Derived from this study: PubMed 41199277Erdem Onder H, Sari D. Improving pressure injury assessment skills of nursing students' using in-situ simulation and moulage: a randomized controlled trial. BMC Nurs. 2025 Nov 6;24(1):1373. doi: 10.1186/s12912-025-04049-x.
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.
Hatice ERDEM ONDER principal investigator
Mehmet Akif Ersoy University
Dilek SARI study director
Ege 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 in-laboratory simulation group and in-situ simulation group in people with Pressure Injury, run by Mehmet Akif Ersoy 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 2 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 May 2024. 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?
Pressure Injury Skill (time frame: four week). 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 NCT06406504, which also lists 1 linked publication.
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 May 2024.