- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527377
Operating Room Nurses' Knowledge of Medical Device-Related Pressure Injuries and Clinical Decision-Making Skills (OR-MDRPI-KnowD)
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aynur Koyuncu, Assoc. Prof.
- Phone Number: Hasan Kalyoncu Üniversitesi Ha
- Email: aynur.koyuncu@hku.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Nurses who withdraw from the study at any stage after providing consent Incomplete or missing data in the questionnaires
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (single assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical Device-Related Pressure Injury Knowledge Score
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2026/008 (Other Identifier: HKU Ethics Committee Approval No)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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