Medical Device-Related Pressure InjuryNCT07553026
ADDIE-Based Training Program for Nurses on Medical Device-Related Pressure Injuries
A study testing ADDIE-Based Training Program in people with Medical Device-Related Pressure Injury and Pressure Injury, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Device-Related Pressure Injury, Pressure Injury, Nursing Education
- What is being tested?
- ADDIE-Based Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, şehitkamil, 27090
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- ADDIE-Based Training Program
- Keywords
- Medical Device-Related Pressure Injury, ADDIE Model, Intensive Care Nursing, Nursing Education, Training Program
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADDIE-Based Training ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: ADDIE-Based Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (pretest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Sep 2025
- Primary completion1 Nov 2025
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical Device-Related Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Dirgar, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553026
- Sponsor's protocol ID
- 2025/101
- Other IDs
- 2025/101
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553026
- Acronym / sponsor ID
- 2025/101
- Keywords
- Medical Device-Related Pressure Injury, ADDIE Model, Intensive Care Nursing, Nursing Education, Training Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ADDIE-Based Training Program | Experimental | Behavioral: ADDIE-Based Training ProgramParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADDIE-Based Training ProgramThe 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 | Behavioural | ADDIE-Based Training Program |
Primary outcome
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.
1 secondary outcome
Correlation Between Perceived Training Effectiveness and Knowledge Outcomes
Time frame: Baseline (pretest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication[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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADDIE-Based Training Program in people with Medical Device-Related Pressure Injury and Pressure Injury, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.