Virtual Reality and AI Wound-detecting System

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367179
• Other study ID #: 202401039RINC
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer

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