NCT07658209

Brief Summary

Brief Summary Pressure injuries are damage to the skin and underlying tissue that may occur in patients who stay in bed for long periods, have limited mobility or use medical devices. These injuries are often preventable. They may cause pain, infection, longer hospital stays and increased care costs. For this reason, it is important that nurses and nursing students have accurate knowledge, confidence and positive attitudes about preventing pressure injuries. The aim of this study is to compare two different methods of teaching pressure injury prevention to nursing students. One group of students received the education in a face-to-face classroom session. The other group completed the same topic through an artificial intelligence-supported modular e-learning programme. The e-learning programme included short videos, clinical examples, question-and-answer activities, short quizzes and feedback. The educational materials prepared with artificial intelligence support were checked by experts before being used with students. Undergraduate nursing students took part in the study. The students were randomly assigned to one of two groups. In both groups, measurements were taken before the education, immediately after the education and four weeks later. The study assessed students' knowledge of pressure injury prevention, their confidence in managing pressure injury prevention and their attitudes towards prevention. This study does not provide a treatment or direct intervention to patients. However, its findings may help improve how nursing students and future healthcare professionals are educated about pressure injury prevention. In the long term, better education may support safer patient care, help prevent pressure injuries and improve the quality of care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 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

May 30, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

16 days

First QC Date

June 9, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Pressure injury preventionPressure ulcer prevention

Outcome Measures

Primary Outcomes (1)

  • Change in Pressure Injury Prevention Knowledge Score

    Outcome Measure Description: Pressure injury prevention knowledge will be assessed using the Turkish version of the Pressure Injury Knowledge Assessment Tool 2.0 (PIKAT 2.0-Tr). The tool evaluates evidence-based knowledge of pressure injury prevention, including aetiology, classification and observation, risk assessment, nutrition, prevention, and care for special patient groups. The total score ranges from 0 to 24, with higher scores indicating higher levels of pressure injury prevention knowledge.

    Baseline, immediately after the intervention, and 4 weeks after the intervention.

Secondary Outcomes (2)

  • Change in Pressure Injury Prevention Self-Efficacy Score

    Baseline, immediately after the intervention, and 4 weeks after the intervention.

  • Change in Attitudes Towards Pressure Injury Prevention Score

    Baseline, immediately after the intervention, and 4 weeks after the intervention.

Study Arms (2)

Face-to-Face Instruction

ACTIVE COMPARATOR

Participants assigned to this arm received conventional face-to-face classroom instruction on pressure injury prevention. The session covered the causes of pressure injuries, classification and observation, risk assessment, nutrition, preventive interventions, care for special patient groups, and medical device-related pressure injuries. The education was delivered using standardised presentation materials.

Behavioral: Face-to-Face Pressure Injury Prevention Education

AI-Supported Modular E-Learning Programme

EXPERIMENTAL

Participants assigned to this arm completed an artificial intelligence-supported modular e-learning programme on pressure injury prevention. The programme included short video presentations, clinical examples, question-and-answer activities, short quizzes and feedback sections. The content covered the same core pressure injury prevention topics as the face-to-face instruction and was reviewed by experts before implementation.

Behavioral: AI-Supported Modular E-Learning Programme

Interventions

Participants received conventional face-to-face classroom instruction on pressure injury prevention. The session was delivered using standardised presentation materials and covered the causes of pressure injuries, classification and observation, risk assessment, nutrition, preventive interventions, care for special patient groups, and medical device-related pressure injuries.

Also known as: Face-to-face instruction Conventional classroom instruction
Face-to-Face Instruction

Participants completed an artificial intelligence-supported modular e-learning programme on pressure injury prevention. The programme included short video presentations, clinical examples, question-and-answer activities, short quizzes and feedback sections. The content covered the same core pressure injury prevention topics as the face-to-face instruction and was reviewed by experts before implementation.

Also known as: AI-supported e-learning programme Modular e-learning programme
AI-Supported Modular E-Learning Programme

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being an undergraduate nursing student.
  • Being aged 18 years or older.
  • Voluntarily agreeing to participate in the study.
  • Providing written informed consent.
  • Being able to participate in the allocated educational intervention and scheduled outcome assessments.

You may not qualify if:

  • Refusing to participate in the study.
  • Having previously received additional structured education on pressure ulcer or pressure injury prevention outside the standard curriculum.
  • Being unable to complete the educational intervention due to absence or withdrawal before intervention delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis 7 Aralık University, Yusuf Şerefoğlu Faculty of Health Sciences, Department of Nursing

Kilis, Kilis, 79000, Turkey (Türkiye)

Location

Related Publications (4)

  • Beeckman D, Defloor T, Demarre L, Van Hecke A, Vanderwee K. Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP). Int J Nurs Stud. 2010 Nov;47(11):1432-41. doi: 10.1016/j.ijnurstu.2010.04.004. Epub 2010 May 14.

    PMID: 20466370BACKGROUND
  • Dellafiore F, Arrigoni C, Ghizzardi G, Baroni I, Conte G, Turrini F, Castiello G, Magon A, Pittella F, Caruso R. Development and validation of the pressure ulcer management self-efficacy scale for nurses. J Clin Nurs. 2019 Sep;28(17-18):3177-3188. doi: 10.1111/jocn.14875. Epub 2019 Apr 21.

    PMID: 30938908BACKGROUND
  • Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.

  • Manderlier B, Van Damme N, Vanderwee K, Verhaeghe S, Van Hecke A, Beeckman D. Development and psychometric validation of PUKAT 2.0, a knowledge assessment tool for pressure ulcer prevention. Int Wound J. 2017 Dec;14(6):1041-1051. doi: 10.1111/iwj.12758. Epub 2017 May 26.

Study Officials

  • İSLAM ELAGÖZ, PhD

    Kilis 7 Aralik University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was used because the educational delivery methods were visibly different. Participants, the intervention provider and the outcome assessors were aware of group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Model Description This is a single-centre, two-arm, parallel-group randomised educational trial with 1:1 allocation. Undergraduate nursing students were randomly assigned to either face-to-face instruction or an artificial intelligence-supported modular e-learning programme for pressure injury prevention education. Outcomes were assessed before the intervention, immediately after the intervention and four weeks after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 18, 2026

Study Start

May 30, 2025

Primary Completion

June 15, 2025

Study Completion

June 20, 2025

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared. The study was conducted with undergraduate nursing students at a single institution, and the dataset may include educational and demographic information that could increase the risk of indirect identification. De-identified aggregate results will be reported in publications and scientific presentations.

Locations