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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06367179
Other study ID # 202401039RINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2024
Est. completion date February 4, 2025

Study information

Verified date February 2024
Source National Taiwan University Hospital
Contact HSIAO-LING YANG, Ph. D.
Phone 02-2312-3456
Email slyang@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date February 4, 2025
Est. primary completion date February 4, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Actual age is over 20 years old. 2. Those who can communicate smoothly in Mandarin and Taiwanese, or those who have the ability to read Chinese. 3. Caregivers of patients with pressure injuries. Exclusion Criteria: 1. Those who suffer from mental or intelligence-related diseases or whose cognitive abilities are insufficient to answer the questionnaire questions. 2. Those who are unable to complete basic demographic information.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality and AI use
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.
Health education leaflet
The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accurate dressing change rate of pressure injury 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 Pressure injury dressing change of self-efficacy 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
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