ADDIE-Based Training Program for Nurses on Medical Device-Related Pressure Injuries

April 22, 2026 updated by: Ezgi Dirgar, University of Gaziantep

Development and Evaluation of an ADDIE Model-Based Training Program to Improve Nursing Care Practices for Medical Device-Related Pressure Injuries: A Pre-Experimental Study

Medical device-related pressure injuries (MDRPIs) are a significant and increasing problem in clinical settings, particularly in intensive care units, adversely affecting patient outcomes and increasing healthcare costs. Nurses play a critical role in the prevention and management of MDRPIs; however, previous studies have shown that their knowledge and practices in this area are often insufficient.

This study aims to develop an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program for nurses and to evaluate its effect on their knowledge and care practices related to MDRPIs. The study is designed as a single-group pretest-posttest pre-experimental study and will be conducted with nurses working in intensive care units.

Data will be collected at three time points: before the training (pretest), immediately after the training (posttest), and one month after the training (follow-up). The training program will be delivered face-to-face using structured educational materials. Outcomes will include changes in nurses' knowledge levels and their evaluations of the training program.

The findings are expected to contribute to improving nursing care practices and enhancing patient safety by supporting effective prevention and management of MDRPIs.

Study Overview

Detailed Description

Medical device-related pressure injuries (MDRPIs) are localized damage to the skin or underlying tissue resulting from sustained pressure caused by medical devices used for diagnostic or therapeutic purposes. These injuries are increasingly reported across healthcare settings, particularly in intensive care units, where patients are exposed to prolonged device use and multiple risk factors. MDRPIs negatively affect patient safety, prolong hospital stays, and increase healthcare costs.

Previous studies have demonstrated that nurses' knowledge and practices regarding MDRPI prevention and management are often insufficient. Factors such as lack of structured education, limited clinical training, and inadequate awareness contribute to suboptimal care practices. Therefore, developing evidence-based and structured educational interventions is essential to improve nurses' competencies in this area.

The ADDIE model (Analysis, Design, Development, Implementation, Evaluation) is a systematic instructional design framework widely used to develop effective educational programs. This model allows for the identification of learning needs, structured content development, and evaluation of learning outcomes.

The aim of this study is to develop an ADDIE model-based training program for nurses on MDRPI prevention and care and to evaluate its effectiveness. The study is designed as a single-group pretest-posttest pre-experimental study.

The study will be conducted in the intensive care units of a state hospital with nurses who meet the inclusion criteria and provide informed consent. The training program will be delivered face-to-face using structured educational materials, including presentations, case examples, and supporting documents.

Data will be collected at three time points: before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up). Data collection tools will include a nurse information form, a validated MDRPI knowledge scale, and a training evaluation questionnaire.

The primary outcome of the study is the change in nurses' knowledge levels regarding MDRPIs. Secondary outcomes include the relationship between knowledge levels and selected demographic and professional variables, as well as participants' satisfaction with the training program.

The results of this study are expected to contribute to improving nursing care quality and patient safety by enhancing nurses' knowledge and supporting the prevention and effective management of MDRPIs.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • şehitkamil
      • Gaziantep, şehitkamil, Turkey (Türkiye), 27090
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Nurses working in the intensive care units of the study hospital Having at least 6 months of continuous work experience in the intensive care unit Voluntarily agreeing to participate in the study Providing written informed consent Agreeing to attend the training program and complete all measurement time points (pretest, posttest, and follow-up)

Exclusion Criteria:

Nurses who are transferred to another unit or leave the institution during the study period Nurses who do not fully attend the training program Nurses who fail to complete any of the data collection tools at any measurement time point Nurses who withdraw from the study at any stage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADDIE-Based Training Program
Participants in this arm will receive an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program designed to improve nurses' knowledge and care practices related to medical device-related pressure injuries. The training will be delivered face-to-face using structured educational materials, including presentations, case examples, and supporting documents. Data will be collected at three time points: before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up).

The intervention consists of an ADDIE (Analysis, Design, Development, Implementation, Evaluation) model-based training program developed to improve nurses' knowledge and care practices related to medical device-related pressure injuries.

In the analysis phase, nurses' educational needs are identified through literature review and assessment of baseline knowledge levels. In the design and development phases, structured educational content, including presentations, case examples, and supporting materials, is prepared based on identified needs and expert input. In the implementation phase, the training program is delivered face-to-face in a classroom setting and lasts approximately 40-60 minutes.

In the evaluation phase, the effectiveness of the training is assessed using repeated measurements of knowledge levels before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up). Additionally, participants' satisfaction wi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nurses' Knowledge Levels on Medical Device-Related Pressure Injuries
Time Frame: From baseline (pretest) to immediately after the intervention (posttest) and 1 month after the intervention (follow-up)
Nurses' knowledge levels will be assessed using a validated Medical Device-Related Pressure Injury Knowledge Scale. The scale consists of multiple items with a total score range from 0 to 25, where higher scores indicate greater knowledge.
From baseline (pretest) to immediately after the intervention (posttest) and 1 month after the intervention (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Perceived Training Effectiveness and Knowledge Outcomes
Time Frame: Baseline (pretest)
Spearman's rank correlation analysis will be conducted to examine the relationship between perceived training effectiveness (assessed via a structured Likert-type questionnaire) and knowledge outcomes (total scores obtained from the MDRPI knowledge scale) at post-test and follow-up time points.
Baseline (pretest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • [1] Makic MBF, "Medical device- related pressure ulcers and intensive care patients," Journal of PeriAnesthesia Nursing , vol. 30, no. 4, pp. 336-337, 2015. [2] Dyer A., "Ten top tips: preventing device-related pressure ulcers," Wounds International 2015;1(5):7-9.; , vol. 5, no. 1, pp. 7-9, 2015. [3] Cooper KL., " Evidence-based prevention of pressure ulcers in the intensive care unit," Crit Care Nurse, vol. 33, no. 6, pp. 57-66, 2013. [4] Galetto SGS, Nascimento ERP, Hermida PMV, and Malfussi LBH, " Medical device-related pressure ınjuries: An integrative literature review," Rev Bras Enferm, vol. 72, no. 2, pp. 505-512, 2019. [5] Jackson D, Sarki AM, Betteridge R, and Brooke J, "Medical devicerelated pressure ulcers: A systematic review and metaanalysis," International Journal of Nursing Studies , vol. 92, pp. 109-120, 2019. [6] A. Parvizi et al., "A systematic review of nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers," Sep. 01, 2023, John Wiley and Sons Inc. doi: 10.1111/iwj.14122. [7] F. Fu, L. Zhang, J. Fang, X. Wang, and F. Wang, "Knowledge of intensive care unit nurses about medical device-related pressure injury and analysis of influencing factors," Int Wound J, vol. 20, no. 4, pp. 1219-1228, Apr. 2023, doi: 10.1111/iwj.13981. [8] N. Tayyib et al., "The effectiveness of the SKINCARE bundle in preventing medical-device related pressure injuries in critical care units: A clinical trial," Adv Skin Wound Care, vol. 34, no. 2, pp. 75-80, Feb. 2021, doi: 10.1097/01.ASW.0000725184.13678.80. [9] P. Özyürek and Ö. Gürlek Kisacik, "Medical device-related pressure injuries prevention practices of intensive care unit nurses: A cross-sectional study in Turkey," J Tissue Viability, vol. 33, no. 2, pp. 262-268, May 2024, doi: 10.1016/J.JTV.2024.03.013. [10] Ö. Erbay Dallı and N. Kelebek Girgin, "Medical Device-Related Pressure Injury Care and Prevention Training Program (DevICeU): Effects on intensive care nurses' knowl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025/101 (Registry Identifier: Hasan Kalyoncu University Non-Interventional Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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