- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677592
Immersive Virtual Reality Training for Stoma Care (IVRT_SC)
The Effectiveness of Immersive Virtual Reality Training for Stoma Care on Nurses' Knowledge and Skill, Self-efficacy and Learning Satisfaction
This study investigates the effectiveness of immersive virtual reality (VR) training in stoma care on nurses' knowledge, skills, self-efficacy, and learning satisfaction.
Using a mixed-method design with convenience sampling, 100 clinical nurses will be recruited and randomly assigned (1:1) to experimental and control groups. The experimental group will receive two VR training sessions one month apart, while the control group will attend a single traditional classroom session. Both groups will follow stoma care replacement procedures established by National Taiwan University Hospital.
Data collection will include demographic information, knowledge/skill tests, and self-efficacy questionnaires administered at three time points: before training, immediately after training, and one month post-training. Learning satisfaction will be assessed immediately after training. Participants reporting adverse VR reactions or scoring below 4 on satisfaction will be invited to one-on-one semi-structured interviews.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to validate the effectiveness of immersive virtual reality training for stoma care on nurses' knowledge and skill, self-efficacy and learning satisfaction.
Skin irritation is the commonest complication of stoma creation. Actuate and comprehensive care for stoma can help to improve patients' quality of life and enhanced outcome of nursing care. Due to lack of consistent, standardized and cost-effective training program, motivation of this study is development of it.
A mixed-method design with convenience sampling will recruit 100 clinical nurses, randomly assigned (1:1) to experimental and control groups. The experimental group will receive two VR training sessions one month apart, while the control group will attend a single traditional classroom session. Both groups will follow stoma care replacement procedures developed by National Taiwan University Hospital, which includes preparation of materials, skin cleansing, stoma pouch application, and key considerations for proper attachment.
Data collection includes demographics, knowledge/skill tests, and self-efficacy questionnaires at three time points: pre-training, immediately post-training, and one month post-training. Learning satisfaction will be assessed immediately after training. Participants with adverse VR reactions or satisfaction scores below 4 will be invited to one-on-one semi-structured interviews.
Data analysis conducts by a SPSS software (version 27.0; SPSS Inc., Chicago, IL, United States). Descriptive statistics include mean, standard deviation and frequency distribution for analyzing the demographic characteristics, and scores of test and questionnaires; independent t-test will be applied for comparing the difference between groups; and qualitative content analysis will be used to understand the management experience on adverse reaction of immersive virtual reality training.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ling-Chun Lu, PhD
- Phone Number: 886-2-33665589
- Email: lulingchun@ntu.edu.tw
Study Contact Backup
- Name: Yi-Wei Chen, BNS
- Phone Number: 886-5-5323911#567338
- Email: lulingchun@ntu.edu.tw
Study Locations
-
-
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Taipei, Taiwan, 10617
- National Taiwn University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full-time registered nurses employed at the study institution or nursing students currently enrolled in a formal nursing program
- Willing to participate in the study and able to provide written informed consent
Exclusion Criteria:
- Prior participation in virtual reality-based ostomy care training
- Self-reported history of significant discomfort during VR use (e.g., dizziness, nausea, or other physical discomfort)
- Individuals who consider themselves unable or unwilling to undergo VR training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: immersive virtual reality training
stoma care with immersive virtual reality device
|
This training program included (1) Scenario: Hospital ward, 56-year-old female post-rectal cancer surgery with temporary colostomy; (2) Intervention: Ostomy care education via immersive VR; (3) Materials: HTC cloud platform, Insta360 camera, tripod, 2 HMDs; (4) Expert Review: Physician, nursing supervisor, academic faculty, wound/ostomy nurse, nurse practitioner; (5) Training: Two 30 minute VR sessions, one month apart, in a quiet hospital meeting room.
|
|
Active Comparator: traditional classroom lecture
lecture with PPT
|
This group received (1) Intervention: Traditional classroom lecture; (2) Format: Two-hour PowerPoint session; (3) Instructor: Certified wound/ostomy nurse; (4) Location: Meeting room with audiovisual facilities, Yunlin Branch.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge and Skills Test of Stoma Care
Time Frame: Assessments will be conducted at three time points: (1) before training (baseline), (2) immediately after training (post-test I), and (3) one month after training (post-test II).
|
The test covers four domains: normal stoma characteristics, standard procedures for ostomy care, principles of managing ostomy leakage, and key points of ostomy care education.
It consists of five single-choice questions, with a total score ranging from 0 to 100.
Higher scores indicate better knowledge and skills in stoma care.
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Assessments will be conducted at three time points: (1) before training (baseline), (2) immediately after training (post-test I), and (3) one month after training (post-test II).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Scale of Stoma Care
Time Frame: Assessments will be conducted at three time points: (1) before training (baseline), (2) immediately after training (post-test I), and (3) one month after training (post-test II).
|
The scale includes 5 items designed to assess nurses' confidence in performing ostomy care tasks.
Each item is rated on a 0-10 scale, with higher scores indicating greater self-efficacy.
Content validity was established by five nursing experts, yielding a CVI of 0.87.
|
Assessments will be conducted at three time points: (1) before training (baseline), (2) immediately after training (post-test I), and (3) one month after training (post-test II).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
standardized institutional training satisfaction questionnaire
Time Frame: There is a time frame: (1) after training immediately.
|
A standardized institutional training satisfaction questionnaire consisting of 5 items will be administered to evaluate participants' learning satisfaction.
Each item will be scored on a 0-10 scale, with higher scores reflecting greater satisfaction.
|
There is a time frame: (1) after training immediately.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ling-Chun Lu, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202603033RINC
- 115-S031 (Other Grant/Funding Number: National Taiwn University Hospital Yunlin Branch)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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