NCT07553026

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 15, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Medical Device-Related Pressure InjuryADDIE ModelIntensive Care NursingNursing EducationTraining Program

Outcome Measures

Primary Outcomes (1)

  • Change in Nurses' Knowledge Levels on Medical Device-Related Pressure Injuries

    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 Outcomes (1)

  • Correlation Between Perceived Training Effectiveness and Knowledge Outcomes

    Baseline (pretest)

Study Arms (1)

ADDIE-Based Training Program

EXPERIMENTAL

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).

Behavioral: ADDIE-Based Training Program

Interventions

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

ADDIE-Based Training Program

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, şehitkamil, 27090, Turkey (Türkiye)

Location

Related Publications (1)

  • [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

    RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A single-group pretest-posttest pre-experimental design with repeated measurements conducted at three time points: before the intervention (pretest), immediately after the intervention (posttest), and one month after the intervention (follow-up).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 27, 2026

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

March 25, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations