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Not yet recruitingNCT05946291Updated Apr 15, 2024

Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation

An interventional study of Pressure injury training and Simulated Manneqquin training in Pressure Injury, sponsored by Tepecik Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Tepecik Training and Research Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pressure Injury

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Keywords

  • pressure injury
  • nursing students
  • simulation
  • moulage
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Tepecik Training and Research Hospital is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteer
  • Intern nursing students

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Standardized Patient Group

    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.

    Other: Pressure injury training

  • Active comparator
    Simulated Manneqquin Group

    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.

    Other: Simulated Manneqquin training

Interventions

  • OtherPressure injury training

    Pressure injury training with mulage application on a standardized patient

  • OtherSimulated Manneqquin training

    Pressure injury training with mulage application on a simulated manneqquin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before and two weeks following applications

  2. 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.

    Time frame: Before and two weeks following applications

07

Study locations

No study locations are listed for this record.

08

References and documents

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 34429220 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2024; primary completion for Dec 2024, 7 months later.

Of 179 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 7 months is below that.

Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2023
First posted
Jul 14, 2023
StartEst.
May 15, 2024
Primary completionEst.
Dec 30, 2024
CompletionEst.
May 30, 2025
Last update
Apr 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05946291
Lead sponsor
Tepecik Training and Research Hospital
Responsible party
Zilan BARAN (Principal Investigator, Tepecik Training and Research Hospital) — Principal investigator
First posted
Jul 14, 2023
Start date
May 15, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Apr 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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