Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
7 de mayo de 2026 actualizado por: Yasemin Özkul, Malatya Turgut Ozal University
The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers.
The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32).
The intervention group will receive VR during diabetic foot care, while the control group will receive standard care.
Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain.
Data analysis will be performed using SPSS 22.0.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Malatya
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Malatya, Malatya, Turquía (Türkiye), 4400
- Malatya Turgut Özal University Training and Research Hospital
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
Exclusion Criteria:
- Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: Intervention Group (VR Group)
Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care.
VR was used as a non-pharmacological distraction method during the procedure.
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Participants in the intervention group received virtual reality (VR) exposure during diabetic foot care procedures.
A virtual reality headset was used as a non-pharmacological distraction method to reduce pain and anxiety.
The VR intervention was applied during the procedure in addition to standard diabetic foot care.
Vital signs such as blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure to evaluate physiological responses.
Otros nombres:
Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention.
Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
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Comparador activo: Control Group
Participants received standard diabetic foot care without virtual reality intervention.
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Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention.
Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Level
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain).
Higher scores indicate greater pain.
Change is calculated as post-test score minus pre-test score.
|
Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in State Anxiety
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
State anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-I), a validated 20-item self-report scale scored 20-80.
Higher scores indicate greater anxiety.
Change is calculated as post-test score minus pre-test score.
|
Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body Temperature
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
Body temperature (°C) measured using a non-contact infrared thermometer (Life Net Medical JA-11C).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Oxygen Saturation (SpO₂)
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Peripheral oxygen saturation (SpO₂, %) measured using a fingertip pulse oximeter (Life Net Medical PFX033).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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Change in Pulse Rate
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
Pulse rate (beats per minute) measured using a fingertip pulse oximeter (Life Net Medical PFX033).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Respiratory Rate
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Respiratory rate (breaths per minute) assessed by direct observation and counting by the researcher.
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Systolic Blood Pressure
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Systolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes.
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Diastolic Blood Pressure
Periodo de tiempo: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
Diastolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes.
Change is calculated as post-test value minus pre-test value.
|
Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de diciembre de 2024
Finalización primaria (Actual)
15 de junio de 2025
Finalización del estudio (Actual)
15 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Diabetes mellitus
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Enfermedades de la piel
- Úlcera de la piel
- Úlcera en la pierna
- Neuropatías diabéticas
- Úlcera del pie
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Dolor
- Desórdenes de ansiedad
- Pie diabético
Otros números de identificación del estudio
- E-30785963-020-266758
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns.
The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .