- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06563830
Prevent Medical Device-Related Pressure Injury
Evaluation of the Training Applied to Nurses Prevent Medical Device-Related Pressure Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Medical Device-Related Pressure Injury account for more than 30% of hospital-related injuries and their incidence has been increasing steadily in recent years. According to the meta-analysis studies (n:126.150 ) the pooled incidence of MDRPI was found to be 12% (95% Cl 8-18) and the pooled prevalence of MDRPIwas found to be 10% (95% Cl 6-16). As can be seen, MDRPI is an important adverse event with a high incidence and prevalence in the world. Despite this, it is known that the MDRPI risk assessment and reporting system is used only in developed countries such as the United Kingdom, the USA and Canada on a limited basis. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the incidence rate of MDRPI is high, the fact that nurses have a low level of MDRPI knowledge draws attention to the importance that should be shown to this issue. In the studies conducted, it is emphasized that in order to prevent MDRPI, more investments should be made in early detection of MDRPI and improvement of the quality of care, and studies including MDRPI risk assessment and reporting strategies are needed.
MDRPI is an important issue that is ignored in nursing education and work areas. The most important task in preventing The most important task in preventing TCIBI falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low. Although its prevalence is high, education, risk assessment, reporting, prevention strategies about MDRPI are very inadequate and evidence-based studies are needed.
In this study, it was aimed to evaluate the effect of training applied to nurses to prevent MDRPI The hypotheses of the study:
H1: The MDRPI knowledge level of nurses is low before the training application.
H2: The incidence of MDRPI is high before the training application.
H03: There is no Deciency between the knowledge levels of nurses before and after the training application.
H4: Training application increases the knowledge level of nurses about MDRPI.
H5: Training application reduces the incidence of MDRPI.
H6: As the level of knowledge of MDRPI of nurses increases, the incidence of MDRPI also increases.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zilan Baran, PhD
- Phone Number: 05061378002
- Email: zilan.baran@outlook.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Although the web-based training to be given within the scope of the study is applied to nurses, the results will be evaluated on both nurses and patient care results. For this reason, both nurses and intensive care inpatients constitute the sample group.
Inclusion Criteria:
Criteria for inclusion of nurses:
-Volunteer
Criteria for inclusion of patients:
- Volunteer
- Who has been hospitalized in intensive care for at least 24 hours
- Do not have a pressure injury during admission to intensive care
Exclusion Criteria:
Exclusion criteria for nurses:
-Do not volunteer
Criteria for inclusion of patients:
- Do not volunteer
- Was admitted to intensive care in less than 24 hours and transferred
- Patients with pressure injuries during admission to intensive care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Evaluation of MRRPI knowledge and attitude levels of nurses
Before the training application, the effectiveness of the training application will be evaluated by applying pre-test and training application followed by two patients and intermittent post-test after three months.
|
The content of the training to be applied to nurses will include: definition of MDRPI, etiology, prevalence and cost, staging, risk factors, nursing initiatives to be implemented to prevent MDRPI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Incidence of Medical Device-Related Pressure Injury
Time Frame: Three months before the training was conducted
|
The incidence of patients hospitalized in intensive care will be determined first in the study.
For this purpose, patients will be observed at the same time every day during their stay in intensive care.
The researcher will fill out the "MDRPI Daily Follow-up Form" for each patient who meets the inclusion criteria during hospitalization.
This form has been created by the researchers in accordance with the literature information.
10 Expert opinions will be submitted before the study is carried out.
|
Three months before the training was conducted
|
|
The Incidence of Medical Device-Related Pressure Injury
Time Frame: Three months before the training was conducted
|
The incidence of patients hospitalized in intensive care will be determined first in the study.
For this purpose, patients will be observed at the same time every day during their stay in intensive care.
If the resulting injury develops, the "Medical Device-Related Pressure Injury Registration Form" will be used and patient monitoring will be continued for wound monitoring and other injuries.
Medical Device-Related Pressure Injury Registration Form: It has been created by the researchers in accordance with the literature information.
10 Expert opinions will be submitted before the study is carried out.
|
Three months before the training was conducted
|
|
Nurse's Knowledge About Medical Device-Related Pressure Injury
Time Frame: within three months prior to the implementation of training
|
Pre-test application will be made with the "MDRPI Knowledge Scale" to determine the level of knowledge and attitude of nurses related to medical device pressure injury before training.
Medical Device-related Pressure Injury Information Scale: The Confirmatory Factor Analysis (CFA) fit indices of the scale consisting of five sub-dimensions with Exploratory Factor Analysis (EFA) were determined as x2= 1.84; RMSEA= 0.05; CFI= 0.91; GFI= 0.92; AGFI= 0.90; RFI= 0.89.
In addition, the total Cronbach alpha coefficient of the scale was found to be 0.798 and the test-retest score was 0.94.
The lowest score that can be taken from the scale is 0 and the highest score is 25.
The increase in the score indicates that the level of knowledge of TCIBY of nurses has increased.
|
within three months prior to the implementation of training
|
|
Nurse's Attitude About Medical Device-Related Pressure Injury
Time Frame: within three months prior to the implementation of training
|
Pre-test application will be made with "The Attidute Towards Medical Device Related Pressure Injuries" to determine the level of attitude of nurses related to medical device pressure injury before training.
Preventing Medical Device-Related Pressure Injury: The Scope Validity Index of the questionnaire was found to be 98.03%, the Cronbach α value was 0.92 and the test-retest score was 0.874.
The lowest score that can be obtained is 11, the highest score is 55, and the high score indicates a positive attitude towards the care and prevention of pressure injuries associated with a medical vehicle.
11 to 25 points, indicates a negative attitude towards the care and prevention of medical vehicle-related pressure injuries, a neutral attitude of 26 to 40 points, and a positive attitude of 41 to 55 points.
|
within three months prior to the implementation of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in the Incidence of Medical Device-Related Pressure Injury
Time Frame: The first three months after the training application
|
In order to determine the effectiveness of the training applied to nurses, the MDRPI incidence of the patients will be determined after the training and compared with the first trimester incidence. For this purpose, patients will be observed at the same time every day during their stay in intensive care. If the resulting injury develops, the "Medical Device-Related Pressure Injury Registration Form" will be used and patient monitoring will be continued for wound monitoring and other injuries. Medical Device-Related Pressure Injury Registration Form: It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out. |
The first three months after the training application
|
|
Decrease in the Incidence of Medical Device-Related Pressure Injury
Time Frame: The first three months after the training application
|
In order to determine the effectiveness of the training applied to nurses, the MDRPI incidence of the patients will be determined after the training and compared with the first trimester incidence. For this purpose, patients will be observed at the same time every day during their stay in intensive care. The researcher will fill out the "Medical Device-Related Pressure Injury Daily Follow-up Form" for each patient who meets the inclusion criteria during hospitalization. Medical Device-Related Pressure Injury Follow-up Form It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out. |
The first three months after the training application
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nurse's Knowledge About Medical Device-Related Pressure Injury
Time Frame: In the second and thirteenth weeks after the training
|
In the second and thirteenth weeks after the training, nurses will be applied with the "MDRPI Knowledge Scale" to determine the level of knowledge of medical device-related pressure injury.
Medical Device-related Pressure Injury Information Scale: The Confirmatory Factor Analysis (CFA) fit indices of the scale consisting of five sub-dimensions with Exploratory Factor Analysis (EFA) were determined as x2= 1.84; RMSEA= 0.05; CFI= 0.91; GFI= 0.92; AGFI= 0.90; RFI= 0.89.
In addition, the total Cronbach alpha coefficient of the scale was found to be 0.798 and the test-retest score was 0.94.
The lowest score that can be taken from the scale is 0 and the highest score is 25.
The increase in the score indicates that the level of knowledge of TCIBY of nurses has increased.
|
In the second and thirteenth weeks after the training
|
|
Nurse's Attitude About Medical Device-Related Pressure Injury
Time Frame: In the second and thirteenth weeks after the training
|
In the second and thirteenth weeks after the training, nurses will be applied with "The Attidute Towards Medical Device Related Pressure Injuries" to determine the level of knowledge and attitude of medical device-related pressure injury.
The Attitude Scale for Preventing Medical Device-Related Pressure Injury: The Scope Validity Index of the questionnaire was found to be 98.03%, the Cronbach α value was 0.92 and the test-retest score was 0.874.
The lowest score that can be obtained is 11, the highest score is 55, and the high score indicates a positive attitude towards the care and prevention of pressure injuries associated with a medical vehicle.
11 to 25 points, indicates a negative attitude towards the care and prevention of medical vehicle-related pressure injuries, a neutral attitude of 26 to 40 points, and a positive attitude of 41 to 55 points.
|
In the second and thirteenth weeks after the training
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Baran Z, Ozden D. Retrospective investigation of pressure injury in COVID-19 patients followed on invasive mechanical ventilator support. J Tissue Viability. 2024 Feb;33(1):144-149. doi: 10.1016/j.jtv.2023.10.001. Epub 2023 Oct 11. Erratum In: J Tissue Viability. 2024 May;33(2):355. doi: 10.1016/j.jtv.2024.02.009.
- Kucukkelepce GE, Karaca T, Ozkan SA. The attitude towards Medical Device-Related Pressure Injuries Questionnaire: a Turkish validity and reliability study. Wound Manag Prev. 2023 Nov;69(4):10-17. doi: 10.25270/wmp.22099.
- Baran, Z., & Özden, D. (2024). Tıbbi Cihaz İlişkili Basınç Yaralanması Bilgi Ölçeği'nin Türkçe Geçerlik ve Güvenirlik Çalışması. İzmir Katip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 9(1), 73-80. https://doi.org/10.61399/ikcusbfd.1356400
Helpful Links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dokuz Eylul University NURSING
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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