NCT06406504

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

May 6, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

In-situ simulationsimulation-based trainingmoulagepressure injurynursing students

Outcome Measures

Primary Outcomes (1)

  • 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.

    four week

Secondary Outcomes (2)

  • Pressure Injury Knowledge

    four week

  • Students' satisfaction and self-confidence scale

    four week

Study Arms (2)

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

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.

Other: in-situ simulation group

Interventions

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-laboratory simulation group

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.

in-situ simulation group

Eligibility Criteria

Age22 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Nursing students who had previously performed classification and assessment of PI
  • Nursing students who do not attend simulation training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hatice ERDEM ONDER

    Mehmet Akif Ersoy University

    PRINCIPAL INVESTIGATOR
  • Dilek SARI

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The participants were randomly assigned to in-laboratory simulation group, in-situ simulation group, and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

September 1, 2021

Primary Completion

May 1, 2023

Study Completion

June 22, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations