- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06367179
Virtual Reality and AI Wound-detecting System
April 14, 2024 updated by: National Taiwan University Hospital
Investigation of Learning Effectiveness and Self-efficacy of Caregivers in Pressure Injury Wound Care Before and After Virtual Reality and AI Wound-detecting System Intervention
This study is an experimental study.
The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects.
During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group.
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.
After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days.
Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pressure injury care is a great burden for caregivers from non-medical backgrounds.
Due to low self-efficacy, caregivers often do not have enough confidence to perform correct wound dressing procedures, which leads to ineffective care of pressure wounds and causes the pressure injury patient's wound repeatedly inflamed and deteriorated.
Therefore, the purpose of this study is to investigate the effectiveness of the intervention on the correctness of dressing change and self-efficacy of pressure injury caregivers through virtual reality of pressure injury education videos and artificial intelligence wound detecting system.
This study is an experimental study.
The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects.
During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group.
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.
After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days.
Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy.
Study Type
Interventional
Enrollment (Estimated)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HSIAO-LING YANG, Ph. D.
- Phone Number: 288895 02-2312-3456
- Email: slyang@ntu.edu.tw
Study Contact Backup
- Name: CHUN-TING LU
- Phone Number: 0905557931
- Email: b09406058@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100225
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Cian Huei Wang
- Phone Number: 263502 (02)23123456
- Email: chw0710@ntuh.gov.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Actual age is over 20 years old.
- Those who can communicate smoothly in Mandarin and Taiwanese, or those who have the ability to read Chinese.
- Caregivers of patients with pressure injuries.
Exclusion Criteria:
- Those who suffer from mental or intelligence-related diseases or whose cognitive abilities are insufficient to answer the questionnaire questions.
- Those who are unable to complete basic demographic information.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.
|
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.
|
Other: Control group
The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.
|
The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accurate dressing change rate of pressure injury
Time Frame: 2 days
|
This scale mainly evaluates the correctness of dressing changes for pressure injuries.
Three pressure injury scales are designed for stage 2 pressure injury, uninfected stage 3 and stage 4 pressure injury, and infected stage 3 and stage 4 pressure injury.
Each scale is divided into three parts, including 1 item for hand hygiene, 6 items for material preparation, and 19 items for wound dressing change, for a total of 26 items.
Medical staff or researchers will rate the participants' dressing change process as correctly performed, incorrectly performed, or not applicable, and the accuracy rate will be used as the evaluation result, that is, the total number of correctly performed questions minus the number of not applicable questions will be divided by the total number of the questions.
The participants need to perform two actual dressing changes on the pressure injury, each time lasting approximately 15 minutes, totally approximately 30 minutes.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure injury dressing change of self-efficacy
Time Frame: 2 days
|
This scale is designed to measure self-efficacy when changing the dressings of pressure injuries.
It contains ten items and uses a four-point Likert scale with options ranging from "completely agree" to "completely disagree."
The total score ranges from ten to forty, with a higher score indicating greater self-efficacy in dressing change for pressure injuries.
Participants must fill out the scale twice, once before and after the intervention, each taking about 5 minutes, totally approximately 10 minutes.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: HSIAO-LING YANG, Ph. D., School of Nursing, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2024
Primary Completion (Estimated)
February 4, 2025
Study Completion (Estimated)
February 4, 2025
Study Registration Dates
First Submitted
March 24, 2024
First Submitted That Met QC Criteria
April 14, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202401039RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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