Medical Device-Related Pressure InjuriesOR-MDRPI-KnowDNCT07527377
Operating Room Nurses' Knowledge of Medical Device-Related Pressure Injuries and Clinical Decision-Making Skills
An observational study of Medical Device-Related Pressure Injuries and Clinical Decision-Making, run by University of Gaziantep.
Trial summary
This multicenter, scenario-based cross-sectional study aims to examine the effect of operating room nurses' knowledge of medical device-related pressure injuries on their clinical decision-making skills. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Device-Related Pressure Injuries, Clinical Decision-Making
- What is being tested?
- None AHT
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2026to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes operating room nurses employed in three hospitals representing different levels of healthcare services (university, city, and state hospitals) in Gaziantep, Türkiye. Nurses with at least one year of operating room experience who meet the inclusion criteria and provide informed consent will be included in the study.
Who may be able to join
- Operating room nurses who have been working in operating rooms for at least one year Nurses who voluntarily agree to participate in the study Nurses who are able to understand and complete the data collection forms
Who cannot join
- Nurses who withdraw from the study at any stage after providing consent Incomplete or missing data in the questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Operating Room Nurses' Knowledge of Medical Device-Related Pressure Injuries on Clinical Decision-Making Skills: A Scenario-Based Multicenter Cross-Sectional Study
This multicenter, scenario-based cross-sectional study aims to examine the effect of operating room nurses' knowledge of medical device-related pressure injuries on their clinical decision-making skills. The study will be conducted with approximately 165 operating room nurses working in three different hospitals in Gaziantep, Türkiye. Data will be collected using a descriptive information form, a validated medical device-related pressure injury knowledge scale, and a scenario-based clinical decision-making assessment form. The study will evaluate the relationship between nurses' knowledge levels and their clinical decision-making performance, as well as identify factors influencing these outcomes. The findings are expected to contribute to improving patient safety, enhancing nursing education, and supporting evidence-based clinical decision-making in perioperative care.
Read the detailed description
Medical device-related pressure injuries (MDRPIs) are a significant and preventable patient safety issue, particularly in perioperative settings where prolonged immobility, decreased tissue perfusion due to anesthesia, and continuous contact with medical devices increase the risk of tissue damage. Studies have reported that the incidence of MDRPIs in surgical patients ranges widely and increases with the duration of surgery. Commonly affected areas include the nasal bridge, ears, lips, and other regions exposed to prolonged pressure from devices such as endotracheal tubes, masks, and fixation materials.
Operating room nurses play a critical role in preventing MDRPIs through appropriate device selection, positioning, skin assessment, and implementation of preventive interventions. International guidelines emphasize the importance of early risk identification and evidence-based clinical decision-making in reducing the occurrence of pressure injuries. However, existing literature indicates variability in nurses' knowledge levels regarding MDRPIs and suggests that this may affect their clinical decision-making processes. Despite the recognized importance of both knowledge and decision-making, studies examining the direct relationship between MDRPI knowledge and clinical decision-making skills among operating room nurses remain limited.
This multicenter, scenario-based cross-sectional study aims to evaluate the effect of operating room nurses' knowledge of MDRPIs on their clinical decision-making skills. The study will be conducted in three hospitals representing different levels of healthcare services in Gaziantep, Türkiye, including a university hospital, a city hospital, and a state hospital. Approximately 165 operating room nurses will be recruited based on predefined inclusion criteria.
Data will be collected using three instruments: a Descriptive Information Form, the Medical Device-Related Pressure Injury Knowledge Scale, and a Scenario-Based Clinical Decision-Making Form developed based on relevant literature and expert opinions. The scenario-based tool consists of multiple clinical situations designed to assess nurses' ability to make appropriate decisions in real-life perioperative contexts.
Data will be analyzed using appropriate statistical methods, including descriptive statistics, group comparisons, correlation analyses, and multiple linear regression to determine the predictive effect of knowledge on clinical decision-making skills. The study is expected to provide evidence on the relationship between knowledge and decision-making in the prevention of MDRPIs and to inform the development of targeted educational interventions aimed at improving perioperative nursing practices and patient safety outcomes.
- Being tested
- None AHT
- Keywords
- Medical Device-Related Pressure Injurie, Operating Room Nurses, Clinical Decision-Making, Pressure Injury Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None AHTOther
Operating room nurses recruited from multiple centers who are assessed for their knowledge of medical device-related pressure injuries and clinical decision-making skills using standardized tools.
| Study group | Role | What they receive |
|---|---|---|
| Operating Room Nurses | Operating room nurses working in different hospitals who participate in the study and complete the knowledge scale and scenario-based clinical decision-making assessment. Receives: Other: None AHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Decision-Making Skills Score
Clinical decision-making skills will be assessed using a scenario-based clinical decision-making form consisting of 15 scenarios. Each correct response is scored as 1 and incorrect responses as 0. Total scores range from 0 to 15, with higher scores indicating better clinical decision-making skills.
Measured: Baseline (single assessment)
Secondary outcomes (1)
Medical Device-Related Pressure Injury Knowledge Score
Knowledge levels will be measured using a 25-item medical device-related pressure injury knowledge scale. Each correct answer is scored as 1, and incorrect or "I don't know" responses are scored as 0. Total scores range from 0 to 25, with higher scores indicating higher knowledge levels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion25 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 InjuriesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (estimated)
- Target duration
- 1 Day
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
- NCT07527377
- Sponsor's protocol ID
- 2026/008
- Other IDs
- 2026/008
- Acronym
- OR-MDRPI-KnowD
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Tobiano, G., Marshall, A. P., Bucknall, T., & Chaboyer, W. (2025). Medical device-related pressure injuries in surgical settings: A scoping review. Journal of Perioperative Nursing, 38(2), 101-112. https://doi.org/10.1016/j.jopan.2025.01.006 2. Hu, Y., Zhang, X., & Liu, Q. (2025). Risk factors and preventive strategies for medical device-related pressure injuries in perioperative patients: A multicenter observational study. International Wound Journal, 22(1), 58-67. https://doi.org/10.1111/iwj.15042 3. Li, J., Zhou, H., & Wang, L. (2025). Incidence and characteristics of medical device-related pressure injuries among surgical patients: A multicenter study. Wound Management & Prevention, 71(3), 45-54. https://doi.org/10.25270/wmp.2025.03.045 4. Aydınlı, A., & Doğan, M. (2025). Tıbbi cihaz kaynaklı basınç yaraları ve hemşirelik yaklaşımları. Türk Klinik Hemşirelik Dergisi, 17(1), 24-33. https://doi.org/10.5336/nurs.2025-95114 5. Fang, Q., Lin, X., & Zhao, Y. (2025). Skin integrity and device fixation methods: Impact on device-related pressure injuries. Journal of Wound Care, 34(4), 210-219. https://doi.org/10.12968/jowc.2025.34.4.210 6. Crunden, E., Dealey, C., & Banks, M. (2025). EWMA, NPIAP, and EPUAP joint statement on prevention and management of medical device-related pressure injuries. Journal of Wound, Ostomy and Continence Nursing, 52(2), 145-152. https://doi.org/10.1097/WON.0000000000000954 7. Aydınlı, A., & Doğan, M. (2025). Tıbbi cihaz kaynaklı basınç yaraları ve hemşirelik yaklaşımları. Türk Klinik Hemşirelik Dergisi, 17(1), 24-33. https://doi.org/10.5336/nurs.2025-95114 8. Crunden, E., Dealey, C., & Banks, M. (2025). EWMA, NPIAP, and EPUAP joint statement on prevention and management of medical device-related pressure injuries. Journal of Wound, Ostomy and Continence Nursing, 52(2), 145-152. https://doi.org/10.1097/WON.0000000000000954 9. Erzincanlı, S., Yıldız, H., & Demir, N. (2025). Ameliyathane hemşirelerinin tıbbi cihaz ilişkili basınç yaralanmala
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Operating Room Nurses' Knowledge of Medical Device-Related Pressure Injuries on Clinical Decision-Making Skills: A Scenario-Based Multicenter Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07527377
- Acronym / sponsor ID
- OR-MDRPI-KnowD / 2026/008
- Keywords
- Medical Device-Related Pressure Injurie, Operating Room Nurses, Clinical Decision-Making, Pressure Injury Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 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.
This multicenter, scenario-based cross-sectional study aims to examine the effect of operating room nurses' knowledge of medical device-related pressure injuries on their clinical decision-making skills. The study will be conducted with approximately 165 operating room nurses working in three different hospitals in Gaziantep, Türkiye. Data will be collected using a descriptive information form, a validated medical device-related pressure injury knowledge scale, and a scenario-based clinical decision-making assessment form. The study will evaluate the relationship between nurses' knowledge levels and their clinical decision-making performance, as well as identify factors influencing these outcomes. The findings are expected to contribute to improving patient safety, enhancing nursing education, and supporting evidence-based clinical decision-making in perioperative care.
Detailed description
Medical device-related pressure injuries (MDRPIs) are a significant and preventable patient safety issue, particularly in perioperative settings where prolonged immobility, decreased tissue perfusion due to anesthesia, and continuous contact with medical devices increase the risk of tissue damage. Studies have reported that the incidence of MDRPIs in surgical patients ranges widely and increases with the duration of surgery. Commonly affected areas include the nasal bridge, ears, lips, and other regions exposed to prolonged pressure from devices such as endotracheal tubes, masks, and fixation materials.
Operating room nurses play a critical role in preventing MDRPIs through appropriate device selection, positioning, skin assessment, and implementation of preventive interventions. International guidelines emphasize the importance of early risk identification and evidence-based clinical decision-making in reducing the occurrence of pressure injuries. However, existing literature indicates variability in nurses' knowledge levels regarding MDRPIs and suggests that this may affect their clinical decision-making processes. Despite the recognized importance of both knowledge and decision-making, studies examining the direct relationship between MDRPI knowledge and clinical decision-making skills among operating room nurses remain limited.
This multicenter, scenario-based cross-sectional study aims to evaluate the effect of operating room nurses' knowledge of MDRPIs on their clinical decision-making skills. The study will be conducted in three hospitals representing different levels of healthcare services in Gaziantep, Türkiye, including a university hospital, a city hospital, and a state hospital. Approximately 165 operating room nurses will be recruited based on predefined inclusion criteria.
Data will be collected using three instruments: a Descriptive Information Form, the Medical Device-Related Pressure Injury Knowledge Scale, and a Scenario-Based Clinical Decision-Making Form developed based on relevant literature and expert opinions. The scenario-based tool consists of multiple clinical situations designed to assess nurses' ability to make appropriate decisions in real-life perioperative contexts.
Data will be analyzed using appropriate statistical methods, including descriptive statistics, group comparisons, correlation analyses, and multiple linear regression to determine the predictive effect of knowledge on clinical decision-making skills. The study is expected to provide evidence on the relationship between knowledge and decision-making in the prevention of MDRPIs and to inform the development of targeted educational interventions aimed at improving perioperative nursing practices and patient safety outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operating Room Nurses | – | Other: None AHTOperating room nurses working in different hospitals who participate in the study and complete the knowledge scale and scenario-based clinical decision-making assessment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes operating room nurses employed in three hospitals representing different levels of healthcare services (university, city, and state hospitals) in Gaziantep, Türkiye. Nurses with at least one year of operating room experience who meet the inclusion criteria and provide informed consent will be included in the study.
Key inclusion criteria (1 listed)
- Operating room nurses who have been working in operating rooms for at least one year Nurses who voluntarily agree to participate in the study Nurses who are able to understand and complete the data collection forms
Key exclusion criteria (1 listed)
- Nurses who withdraw from the study at any stage after providing consent Incomplete or missing data in the questionnaires
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 |
|---|---|---|
| None AHTOperating room nurses recruited from multiple centers who are assessed for their knowledge of medical device-related pressure injuries and clinical decision-making skills using standardized tools. | Other | Operating Room Nurses |
Primary outcome
Clinical Decision-Making Skills Score
Time frame: Baseline (single assessment)
Clinical decision-making skills will be assessed using a scenario-based clinical decision-making form consisting of 15 scenarios. Each correct response is scored as 1 and incorrect responses as 0. Total scores range from 0 to 15, with higher scores indicating better clinical decision-making skills.
1 secondary outcome
Medical Device-Related Pressure Injury Knowledge Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication1. Tobiano, G., Marshall, A. P., Bucknall, T., & Chaboyer, W. (2025). Medical device-related pressure injuries in surgical settings: A scoping review. Journal of Perioperative Nursing, 38(2), 101-112. https://doi.org/10.1016/j.jopan.2025.01.006 2. Hu, Y., Zhang, X., & Liu, Q. (2025). Risk factors and preventive strategies for medical device-related pressure injuries in perioperative patients: A multicenter observational study. International Wound Journal, 22(1), 58-67. https://doi.org/10.1111/iwj.15042 3. Li, J., Zhou, H., & Wang, L. (2025). Incidence and characteristics of medical device-related pressure injuries among surgical patients: A multicenter study. Wound Management & Prevention, 71(3), 45-54. https://doi.org/10.25270/wmp.2025.03.045 4. Aydınlı, A., & Doğan, M. (2025). Tıbbi cihaz kaynaklı basınç yaraları ve hemşirelik yaklaşımları. Türk Klinik Hemşirelik Dergisi, 17(1), 24-33. https://doi.org/10.5336/nurs.2025-95114 5. Fang, Q., Lin, X., & Zhao, Y. (2025). Skin integrity and device fixation methods: Impact on device-related pressure injuries. Journal of Wound Care, 34(4), 210-219. https://doi.org/10.12968/jowc.2025.34.4.210 6. Crunden, E., Dealey, C., & Banks, M. (2025). EWMA, NPIAP, and EPUAP joint statement on prevention and management of medical device-related pressure injuries. Journal of Wound, Ostomy and Continence Nursing, 52(2), 145-152. https://doi.org/10.1097/WON.0000000000000954 7. Aydınlı, A., & Doğan, M. (2025). Tıbbi cihaz kaynaklı basınç yaraları ve hemşirelik yaklaşımları. Türk Klinik Hemşirelik Dergisi, 17(1), 24-33. https://doi.org/10.5336/nurs.2025-95114 8. Crunden, E., Dealey, C., & Banks, M. (2025). EWMA, NPIAP, and EPUAP joint statement on prevention and management of medical device-related pressure injuries. Journal of Wound, Ostomy and Continence Nursing, 52(2), 145-152. https://doi.org/10.1097/WON.0000000000000954 9. Erzincanlı, S., Yıldız, H., & Demir, N. (2025). Ameliyathane hemşirelerinin tıbbi cihaz ilişkili basınç yaralanmala
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Device-Related Pressure Injuries and Clinical Decision-Making, run by University of Gaziantep.
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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aynur Koyuncu, Assoc. Prof. (Hasan Kalyoncu Üniversitesi Ha, aynur.koyuncu@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Decision-Making Skills Score (time frame: Baseline (single assessment)). 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 NCT07527377, 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 14 Apr 2026.