- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06900179
The Effectiveness of Augmented Reality Facilitated Education in Promoting Care Management of Malignant Fungating Wounds Among Oncology Nurses
Malignant fungating wounds (MFWs) affect 5-14% of patients with advanced cancer, making them a common complication in this population. Characterized by symptoms such as foul odor, heavy exudate, bleeding, moderate to severe pain, and infection, MFWs cause significant physical discomfort and pose life-threatening risks while also leading to profound psychosocial issues, including shame and social isolation. These factors severely impact patients' quality of life, with half of those diagnosed surviving only six months on average.
However, clinical nursing staff often lack adequate knowledge and skills in managing MFWs, with an average accuracy rate of just 56.5%. Notable deficiencies exist in areas such as wound disinfection, odor control, and wound assessment, directly affecting the quality of patient care and highlighting an urgent need for specialized MFW training. Traditional MFW education often lacks real-life clinical scenarios and hands-on practice, resulting in a gap between learning and application and leaving learners ill-prepared for the complexities of clinical settings.
In contrast, augmented reality (AR) technology presents new possibilities for nursing education. AR can create highly simulated clinical environments where learners can safely practice complex clinical skills, enhancing clinical decision-making abilities. The implementation of AR-based training programs provides nursing staff with a more realistic and effective learning experience, allowing them to better address the challenges posed by MFWs and ultimately contributing to improvements in patient care and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Taipei City
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New Taipei City, New Taipei City, Taiwan, 251404
- MacKay Memorial Hosital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full-time nursing staff working in oncology wards at a teaching hospital in northern Taiwan
- Individuals willing to participate in the study and who have signed the informed consent form
Exclusion Criteria:
- Nursing staff not assigned to oncology-related wards
- Individuals expected to be unable to complete full participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Augmented Reality
Participants in the experimental group will receive an introduction to updated malignant fungating wound (MFWs) care guidelines and clinical applications, covering essential topics such as evidence-based wound management techniques, odor control, exudate handling, bleeding prevention, and pain management.
Training will also address the identification and management of common MFWs-related complications, including infection.
Additionally, participants will utilize the "MFWs with AR" program, engaging in simulated scenarios to enhance clinical reasoning and decision-making skills.
|
MFWs with AR This study utilized MyWeb AR as the primary development platform to create an AR-enhanced teaching curriculum for malignant fungating wound (MFW) care.
Based on the 2022 Clinical Care Guidelines for Malignant Fungating Wounds and expert input from oncology specialists, the content covers key aspects of MFW care, including wound assessment, symptom identification, and care principles such as odor control, exudate management, and infection prevention.
The program uses 3D object elements and animations to create interactive AR scenarios, allowing participants to engage in simulated clinical decision-making and care management, thereby enhancing their skills in a safe and controlled environment.
|
|
Placebo Comparator: Classroom Teaching
Classroom Teaching and Case Sharing Introduction to Updated MFWs Care Guidelines and Clinical Applications MFWs Wound Care Management of Common MFWs-Related Complications
|
Classroom Teaching and Case Sharing Introduction to Updated MFWs Care Guidelines and Clinical Applications MFWs Wound Care Management of Common MFWs-Related Complications Case Sharing on MFWs Complication Management: Researchers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MFWs care Knowledge scale
Time Frame: 6months
|
1. **MFWs Care Knowledge Scale** This study will assess MFWs care knowledge using the **MFWs Care Knowledge Scale**. The scale ranges from **0 to 100**, with higher scores indicating **better** knowledge levels. The assessment will be conducted at **baseline and post-intervention** to measure changes in MFWs care knowledge over time. |
6months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Reasoning Scale
Time Frame: 6months
|
This study will assess clinical reasoning ability using the Clinical Reasoning Scale.
The scale ranges from 16 to 80, with higher scores representing better clinical reasoning ability.
Measurements will be taken before and after the intervention to assess changes in clinical reasoning performance.
|
6months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Other Study ID Numbers
- 24MMHIS089e
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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