- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406504
Improving Pressure Injury Classification and Assessment Skills: In Situ Simulation and Moulage
A Realistic Experience in Improving Pressure Injury Classification and Assessment Skills: In Situ Simulation and Moulage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Burdur, Turkey
- Mehmet Akif Ersoy University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Nursing students who had previously performed classification and assessment of PI
- Nursing students who do not attend simulation training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: in-laboratory simulation group
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
|
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.
|
Experimental: in-situ simulation group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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four week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Injury Knowledge
Time Frame: four week
|
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.
|
four week
|
Students' satisfaction and self-confidence scale
Time Frame: four week
|
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.
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four week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dilek SARI, Ege University
- Principal Investigator: Hatice ERDEM ONDER, Mehmet Akif Ersoy University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MehmetAkifU-SBF-HEÖ-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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