- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07617415
Virtual Reality Supported by Wearable Technology on Nursing Students
Effects of Immersive Virtual Reality Supported by Wearable Technology on Clinical Anxiety, Stress, and Adaptation in Nursing Students: A Randomized Controlled Trial
This study will examine the effects of brief immersive virtual reality (IVR) exposure (10-15 minutes) using commercially available applications (Beat Saber, TRIPP) on nursing students' clinical anxiety, stress, and adaptation, compared with usual clinical preparation in a control group. It will be assumed that anxiety experienced during clinical practice may negatively affect students' success.
The research will be designed as a prospective, randomized controlled trial. The study will be conducted with 195 students enrolled in the Department of Surgical Nursing at the Faculty of Nursing of an academic institution. Students will be divided into two groups using a simple randomization method. Those in the intervention group will practice with IVR goggles in the clinical setting, engaging in game-based activities involving breathing exercises and aerobics. Data will be collected using the Demographics Questionnaire, State-Trait Anxiety Inventory, Clinical Success Evaluation Form, and the Stress, Adaptation, and Satisfaction Scale, and these measures will be correlated with clinical success.
It is anticipated that the IVR application will help reduce clinical anxiety and stress by fostering alternative perceptions of the environment. Students are expected to demonstrate high levels of engagement and immersion in the virtual environment. Although within-group changes in state anxiety may not be statistically significant, between-group comparisons are expected to show lower post-intervention anxiety scores in the IVR group compared with the control group (p≈0.02).
In conclusion, brief IVR exposure is expected to be associated with reduced self-reported stress and improved adaptation compared with usual clinical preparation, while its effects on standardized anxiety scores and objective clinical success may remain limited. Additionally, the type of VR experience is expected to influence the outcomes.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study will examine the effects of brief immersive virtual reality (IVR) exposure (10-15 minutes) using commercially available applications (Beat Saber, TRIPP) on nursing students' clinical anxiety, stress, and adaptation, compared with usual clinical preparation in a control group. It will be assumed that anxiety experienced during clinical practice may negatively affect students' success.
The research will be designed as a prospective, randomized controlled trial. The study will be conducted with 195 students enrolled in the Department of Surgical Nursing at the Faculty of Nursing of an academic institution. Students will be divided into two groups using a simple randomization method. Those in the intervention group will practice with IVR goggles in the clinical setting, engaging in game-based activities involving breathing exercises and aerobics. Data will be collected using the Demographics Questionnaire, State-Trait Anxiety Inventory, Clinical Success Evaluation Form, and the Stress, Adaptation, and Satisfaction Scale, and these measures will be correlated with clinical success.
It is anticipated that the IVR application will help reduce clinical anxiety and stress by fostering alternative perceptions of the environment. Students are expected to demonstrate high levels of engagement and immersion in the virtual environment. Although within-group changes in state anxiety may not be statistically significant, between-group comparisons are expected to show lower post-intervention anxiety scores in the IVR group compared with the control group (p≈0.02).
In conclusion, brief IVR exposure is expected to be associated with reduced self-reported stress and improved adaptation compared with usual clinical preparation, while its effects on standardized anxiety scores and objective clinical success may remain limited. Additionally, the type of VR experience is expected to influence the outcomes.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Gümüşhane, Turecko (Türkiye)
- Gumushane University
-
Gümüşhane, Turecko (Türkiye), 28010
- Aydanur AYDIN
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion criteria:
-Be the undergraduate nursing student enrolled in the "Surgical Nursing" course in a pre-bachelor degree program at the University
Exclusion criteria:
- Had vision impairment that prevented them from watching IVR videos, neck pain or injury that prevented them from moving their head, or an open wound that prevented them from wearing the IVR headset
- Experienced nausea and dizziness when watching IVR videos
- Had epileptic symptoms.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Řízení
|
|
|
Experimentální: Immersive Virtual Reality
|
Virtual Reality goggles
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The stress scale
Časové okno: Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
The stress scale consists of a linear rating system that includes nursing students' assessments of the experience they received.
The single-question inventory asked students to rate their satisfaction on a scale of 0 (very dissatisfied) to 10 (very satisfied).
The responses were used to determine students' stress levels using IVR goggles.
|
Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
|
The Clinical Success
Časové okno: Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
The Clinical Success Evaluation Form (CSEF) is an evaluation form developed by the second and third authors in 2005 for the Surgical Nursing course at their institution.
The form is used by all lecturers and mentor nurses conducting the course to evaluate the success of the students in clinical practice.
In the form, scored in three sections (knowledge, skills, behaviors).
Behavioral anchors were provided for each item to improve objectivity.
|
Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
|
Clinical anxiety levels
Časové okno: Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
The State Anxiety Inventory (SAI) is a self-report scale comprising 20 brief statements designed to assess an individual's emotional state at a specific point in time and under particular circumstances.
The emotions and behaviors expressed in the State Anxiety Scale items are answered by marking one of the conditions, namely (1) not at all, (2) a little, (3) a lot, and (4) completely, according to the severity of such experiences.
|
Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
|
The clinical adaptations
Časové okno: Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
The Clinical Adaptation Scale consists of a linear rating system that includes nursing students' assessments of the experience they received.
The single-question inventory asked students to rate their adaptation on a scale of 0 (very dissatisfied) to 10 (very satisfied).
|
Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
|
The Satisfaction Scale
Časové okno: Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
The Satisfaction Scale consists of a linear rating system that includes nursing students' assessments of the experience they received.
The single-question inventory asked students to rate their satisfaction on a scale of 0 (very dissatisfied) to 10 (very satisfied).
|
Baseline and post-intervention measurement (at the end of clinical practice, 14th week of the semester)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- GumushaneUni10
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Immersive Virtual Reality
-
University of BaselSwiss National Science Foundation; Universitäre Psychiatrische Kliniken (UPK)... a další spolupracovníciZatím nenabíráme
-
Assistance Publique - Hôpitaux de ParisZatím nenabíráme
-
Swiss Paraplegic Research, NottwilNáborPoranění míchy (SCI) | Neuropatická bolest způsobená poraněním míchyŠvýcarsko
-
University of Colorado, DenverSan Diego State University; University of Kansas Medical CenterNáborHPV infekce | Preventivní zdravotní službySpojené státy
-
Berker OkayNáborStres, psychologický | Úzkost | StrachTurecko (Türkiye)
-
Martini-Klinik am UKE GmbHNáborRakovina prostaty (adenokarcinom)Německo
-
Johns Hopkins UniversityItamar-Medical, Israel; Apple Inc.; Pharmaceutical Research & Manufacturers Of...NáborFibrilace síní | ChováníSpojené státy
-
Johns Hopkins UniversityDokončenoFibrilace síní | ChováníSpojené státy
-
Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de BarcelonaNáborFibromyalgieŠpanělsko
-
Consorci Sanitari de TerrassaNáborMetabolický syndromŠpanělsko