- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ling-Chun Lu, PhD
- Telefonnummer: 886-2-33665589
- E-Mail: lulingchun@ntu.edu.tw
Studieren Sie die Kontaktsicherung
- Name: Yi-Wei Chen, BNS
- Telefonnummer: 886-5-5323911#567338
- E-Mail: lulingchun@ntu.edu.tw
Studienorte
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Taipei, Taiwan, 10617
- National Taiwn University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: immersive virtual reality training
stoma care with immersive virtual reality device
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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.
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Aktiver Komparator: traditional classroom lecture
lecture with PPT
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Knowledge and Skills Test of Stoma Care
Zeitfenster: 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).
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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).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Self-Efficacy Scale of Stoma Care
Zeitfenster: 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).
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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.
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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).
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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standardized institutional training satisfaction questionnaire
Zeitfenster: There is a time frame: (1) after training immediately.
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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.
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There is a time frame: (1) after training immediately.
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ling-Chun Lu, National Taiwan University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 202603033RINC
- 115-S031 (Andere Zuschuss-/Finanzierungsnummer: National Taiwn University Hospital Yunlin Branch)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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