- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07620873
Effects of Virtual Reality Education on Anxiety and Learning in Patients Undergoing Urolithiasis Surgery (VR-URO)
The Effects of Two-Tier Test-Based Virtual Reality Education on Anxiety, Knowledge, Self-Care Ability, and Cognitive Load in Patients Undergoing Urolithiasis Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Preoperative anxiety is a common concern among patients undergoing urolithiasis surgery and may adversely affect perioperative experiences, treatment adherence, and postoperative recovery. Conventional preoperative education is often limited by time constraints, variability in information delivery, and insufficient patient engagement.
Virtual reality (VR)-based education has emerged as an innovative educational approach that provides immersive and interactive learning experiences. Previous studies have suggested that VR may improve patient understanding of surgical procedures and reduce anxiety by familiarizing patients with the perioperative environment. However, most existing VR education programs provide information passively and may not adequately identify or correct patient misconceptions.
The present study introduces a two-tier virtual reality educational approach that integrates immersive VR scenarios with structured knowledge assessment and feedback mechanisms. By encouraging participants to actively process information and receive immediate clarification of misunderstandings, the intervention is expected to enhance learning effectiveness and support patient self-management.
This randomized controlled trial aims to examine whether a two-tier VR educational strategy can provide additional benefits beyond standard VR education and routine preoperative instruction for patients undergoing urolithiasis surgery. Findings from this study may contribute to the development of more effective patient-centered educational interventions and provide evidence for the integration of advanced VR technologies into perioperative nursing practice.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: wellin Huang, RN, MSN Student
- Número de teléfono: +886 953713535
- Correo electrónico: hwl0111@gmail.com
Ubicaciones de estudio
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Keelung, Taiwán, 204
- Reclutamiento
- Keelung Chang Gung Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients scheduled to undergo urolithiasis surgery with procedure codes 77026B, 77027B, 77028B, or 76016B.
- Aged 18 years or older.
- Conscious and mentally alert.
- Able to communicate in Mandarin Chinese and read written text.
- Able to understand and operate virtual reality equipment.
Exclusion Criteria:
- Patients with current psychiatric disorders or substance abuse.
- Patients with hearing or visual impairment.
- Patients with visual dizziness, vertigo, or virtual reality motion sickness symptoms.
- Patients who are unable to cooperate or unwilling to participate in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Routine Patient Education
Participants receive routine preoperative education provided by clinical nursing staff before urolithiasis surgery.
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Experimental: VR Education
Participants receive standard virtual reality-based preoperative education before urolithiasis surgery.
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Participants receive standard virtual reality-based preoperative education before urolithiasis surgery.
The VR program includes immersive 360-degree educational content covering the preoperative process, operating room environment, postoperative care, and self-care instructions.
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Experimental: Two-Tier VR Education
Participants receive two-tier virtual reality-based preoperative education with integrated interactive questioning and feedback before urolithiasis surgery.
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Participants receive two-tier virtual reality-based preoperative education before urolithiasis surgery.
The intervention combines immersive 360-degree VR educational content with a two-tier testing mechanism designed to enhance learning comprehension, self-care knowledge, and cognitive engagement.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Anxiety Score Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Periodo de tiempo: Baseline before intervention, 2 hours after intervention, and postoperative day 1
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Anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The APAIS consists of 6 items scored on a 5-point Likert scale. Total scores range from 6 to 30, with higher scores indicating greater preoperative anxiety and information needs. The HADS-A consists of 7 items scored from 0 to 3. Total scores range from 0 to 21, with higher scores indicating greater anxiety. |
Baseline before intervention, 2 hours after intervention, and postoperative day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Urolithiasis Surgery Knowledge Questionnaire Score
Periodo de tiempo: Baseline before intervention and 2 hours after intervention
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Knowledge regarding perioperative care for urolithiasis surgery will be assessed using a researcher-developed Urolithiasis Surgery Knowledge Questionnaire. The baseline questionnaire consists of 10 multiple-choice items and the post-intervention questionnaire consists of 20 multiple-choice items covering surgical preparation, operating room orientation, perioperative care, urinary catheter care, Double-J stent management, dietary management, hydration, complication recognition, and prevention of stone recurrence. Scores range from 0 to 10 at baseline and from 0 to 20 after intervention. Higher scores indicate better understanding of urolithiasis surgery and postoperative self-care |
Baseline before intervention and 2 hours after intervention
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Postoperative Self-Care Ability Score Measured by the Urolithiasis Self-Care Ability Scale
Periodo de tiempo: Postoperative day 1
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Postoperative self-care ability will be assessed using the Urolithiasis Postoperative Self-Care Ability Scale developed by Hu et al. (2024). The scale consists of 30 items across five domains, including disease management, diet and fluid intake, psychosocial management, activity and elimination, and disease-related information. Each item is rated on a 5-point Likert scale. Total scores range from 30 to 150. Higher scores indicate better postoperative self-care ability. |
Postoperative day 1
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Cognitive Load Score Measured by the Cognitive Load Questionnaire
Periodo de tiempo: 2 hours after intervention
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Cognitive load will be assessed using the Cognitive Load Questionnaire developed by Klepsch et al. (2017). The questionnaire contains 8 items assessing intrinsic cognitive load, extraneous cognitive load, and germane cognitive load. Each item is rated on a 5-point Likert scale. Total scores range from 8 to 40. Higher scores indicate greater perceived cognitive load during learning. |
2 hours after intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales masculinas
- Cálculos
- Condiciones Patológicas, Anatómicas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Cálculos urinarios
- Nefrolitiasis
- Condiciones Patológicas, Signos y Síntomas
- Cálculos renales
- Desórdenes de ansiedad
- Urolitiasis
Otros números de identificación del estudio
- 202600523B0
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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