NCT06563830

Brief Summary

Medical Device-Related Pressure Injury (MDRPI) is a localized skin and/or subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Medical device-related pressure injuries are an important adverse event with a high incidence and prevalence both in our country and in the world, accounting for more than 30% of hospital-related injuries. 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 most important task in preventing medical device-related pressure injuries falls on nurses, it is quite noticeable that nurses' knowledge levels of MDRPI are low in the studies conducted. MDRPI is an important issue that is ignored in nursing education and work areas in our country. In order to prevent pressure injuries associated with medical devices, it is necessary to invest more in early detection of MDRPI and improving the quality of care, studies including MDRPI risk assessment and reporting strategies are needed. In the project to be carried out in this context, it is aimed to evaluate the impact of training applied to nurses to prevent MDRPI.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

August 8, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

August 8, 2024

Last Update Submit

October 12, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Incidence of Medical Device-Related Pressure Injury

    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

    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

    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

    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 Outcomes (2)

  • Decrease in the Incidence of Medical Device-Related Pressure Injury

    The first three months after the training application

  • Decrease in the Incidence of Medical Device-Related Pressure Injury

    The first three months after the training application

Other Outcomes (2)

  • Nurse's Knowledge About Medical Device-Related Pressure Injury

    In the second and thirteenth weeks after the training

  • Nurse's Attitude About Medical Device-Related Pressure Injury

    In the second and thirteenth weeks after the training

Study Arms (1)

Evaluation of MRRPI knowledge and attitude levels of nurses

OTHER

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.

Other: educational application

Interventions

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.

Evaluation of MRRPI knowledge and attitude levels of nurses

Eligibility Criteria

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

You may qualify if:

  • Volunteer
  • Volunteer
  • Who has been hospitalized in intensive care for at least 24 hours
  • Do not have a pressure injury during admission to intensive care

You may not qualify if:

  • Do not volunteer
  • Do not volunteer
  • Was admitted to intensive care in less than 24 hours and transferred
  • Patients with pressure injuries during admission to intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 38090951BACKGROUND
  • 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.

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zilan Baran, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The three months incidence of medical device-related pressure injuries of patients admitted to intensive care before and after the training will be examined. At this stage, it will be conducted by two independent observers. Simultaneous monitoring will be carried out during the first week, and the harmony between the observers will be evaluated by a third party, and it will be ensured that the observations are measured Decently with the same standard. However, the bias will be reduced by having different people enter the data of the research and analyze the data.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: It is planned to conduct the study as a semi-experimental, single-group pre-test-post-test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 21, 2024

Study Start

November 1, 2024

Primary Completion

March 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 16, 2024

Record last verified: 2024-10