NCT06367179

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2025

Completed
Last Updated

April 16, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

March 24, 2024

Last Update Submit

April 14, 2024

Conditions

Keywords

Virtual realitywound careArtificial IntelligenceSelf-efficacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pressure injury dressing change of self-efficacy

    2 days

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.

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.

Other: Health education leaflet

Interventions

The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system.

Experimental group

The control group maintained the traditional pressure injury health education with oral introduction and health education leaflet.

Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • HSIAO-LING YANG, Ph. D.

    School of Nursing, National Taiwan University

    STUDY CHAIR

Central Study Contacts

HSIAO-LING YANG, Ph. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 16, 2024

Study Start

March 22, 2024

Primary Completion

February 4, 2025

Study Completion

February 4, 2025

Last Updated

April 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations