Pressure InjuryNCT06367179
Virtual Reality and AI Wound-detecting System
A study testing Virtual reality and AI use and Health education leaflet in people with Pressure Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Virtual reality and AI use and Health education leaflet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Mar 2024to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Cian Huei Wang, (02)23123456 ext. 263502, chw0710@ntuh.gov.tw
About this study
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
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.
Read the 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.
- Conditions
- Pressure Injury
- Being tested
- Virtual reality and AI use, Health education leaflet
- Keywords
- Virtual reality, wound care, Artificial Intelligence, Self-efficacy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality and AI useOther
The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.
Health education leafletOther
The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system. Receives: Other: Virtual reality and AI use |
| Control group | Other | The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. Receives: Other: Health education leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (1)
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start22 Mar 2024
- Primary completion4 Feb 2025 (estimated)
- Study completion4 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HSIAO-LING YANG, Ph. D., Study chair, School of Nursing, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367179
- Sponsor's protocol ID
- 202401039RINC
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06367179
- Acronym / sponsor ID
- 202401039RINC
- Conditions
- Pressure Injury
- Keywords
- Virtual reality, wound care, Artificial Intelligence, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 4 Feb 2025 (estimated)
- Study completion
- 4 Feb 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual reality and AI useThe experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system. |
| Control group | Other | Other: Health education leafletThe control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality and AI useThe experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system. | Other | Experimental group |
| Health education leafletThe control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. | Other | Control group |
Primary outcome
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.
1 secondary outcome
Pressure injury dressing change of self-efficacy
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HSIAO-LING YANG, Ph. D. study chair
School of Nursing, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and AI use and Health education leaflet in people with Pressure Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HSIAO-LING YANG, Ph. D. (02-2312-3456 ext. 288895, slyang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate dressing change rate of pressure injury (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.