NCT05946291

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

May 17, 2023

Last Update Submit

April 11, 2024

Conditions

Keywords

pressure injurynursing studentssimulationmoulage

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Before and two weeks following applications

Study Arms (2)

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.

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.

Other: Simulated Manneqquin training

Interventions

Pressure injury training with mulage application on a standardized patient

Standardized Patient Group

Pressure injury training with mulage application on a simulated manneqquin

Simulated Manneqquin Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer
  • Intern nursing students

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34429220BACKGROUND
  • Baran 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.

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Students will be assigned to the experiment and control group blind. In addition, double-blind randomization will be provided by appointing a blind researcher who performs the analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study is planned as a double-blind randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2023

First Posted

July 14, 2023

Study Start

May 15, 2024

Primary Completion

December 30, 2024

Study Completion

May 30, 2025

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share