Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients (VirtualReality)
Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial
This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels.
The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis center. Participants will be randomly assigned to an experimental group (n=25) and a control group (n=25).
Patients in the experimental group will be shown visual-auditory content via VR goggles during AVF needle insertion, while the control group will receive routine care. Data will be collected using the Demographic Information Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Statistical analyses will include appropriate comparative and correlational tests to evaluate differences between groups and relationships between variables.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After generating the randomization list for participant allocation, the study materials will be prepared, including informed consent forms, the Descriptive Characteristics Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI).
Participants will be assigned to experimental and control groups according to the randomization list. In the experimental group, virtual reality intervention will be applied during AVF needle insertion, while the control group will receive standard care procedures.
To ensure standardization of the cannulation procedure, all patients in both groups will be cannulated using a 16-gauge arterial and venous needle, inserted at a 30°-45° angle and at least 5 cm from the fistula region, by the same certified hemodialysis nurse. The needle will be secured with hypoallergenic tape.
Fifteen minutes after fistula cannulation, outcome measurements will be performed using the Visual Analog Scale (VAS) and the State Anxiety Inventory (SAI).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Selçuklu
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Konya, Selçuklu, Turquía (Türkiye), 42020
- Daviva Private Konya Dialysis Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18 years of age or older,
- Receiving treatment via AVF,
- Having no visual impairment,
- Giving voluntary consent.
Exclusion Criteria:
- Patients with catheter use,
- Communication problems,
- Antipsychotic medication use,
- Analgesic use in the last 12 hours,
- Failed (multiple) needle insertion attempts
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual Reality Group
Patients receive VR during cannulation
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Prior to cannulation, SG goggles were worn, immersive visual/auditory content was shown during the procedure, and the goggles were removed 15 minutes after needle insertion for final measurements.
To standardize the procedure, all needle insertions were performed by the same experienced nurse, using a size 16 needle, at least 5 cm away from the fistula site, and at an angle of 30°-45°.
Otros nombres:
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Comparador activo: Control Group
Routine Procedure
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Only the clinic's routine procedures were followed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity
Periodo de tiempo: 15 minutes after AVF cannulation
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Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate greater pain intensity.
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15 minutes after AVF cannulation
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Anxiety Level
Periodo de tiempo: 15 minutes after AVF cannulation
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Anxiety levels will be assessed using the State Anxiety Inventory (SAI).
Higher scores indicate higher anxiety levels.
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15 minutes after AVF cannulation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Pain Intensity from BaselineBaseline Values"
Periodo de tiempo: From 15 minutes before cannulation to 15 minutes after cannulation
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Change in VAS score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.
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From 15 minutes before cannulation to 15 minutes after cannulation
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Change in Anxiety Level from Baseline
Periodo de tiempo: From 15 minutes before cannulation to 15 minutes after cannulation
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Change in SAI score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.
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From 15 minutes before cannulation to 15 minutes after cannulation
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Manifestaciones neurológicas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Condiciones Patológicas, Anatómicas
- Anomalías congénitas
- Anomalías cardiovasculares
- Malformaciones Vasculares
- Fístula
- Malformaciones arteriovenosas
- Fístula vascular
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Desórdenes de ansiedad
- Fístula arteriovenosa
Otros números de identificación del estudio
- KTO Karatay University AVFSTL
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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