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Effect of Virtual Reality on Agitation in Acute Stroke

23 de agosto de 2026 actualizado por: Nazlı Can Denizhan, Ankara Etlik City Hospital

The Effect of Virtual Reality Application on Agitation in Individuals With Acute Stroke: A Randomized Controlled Single-Blind Study

This randomized controlled, single-blind study evaluates the effect of a Virtual Reality (VR) application on agitation levels and physiological vital signs in patients with acute stroke. Participants are randomly assigned to an intervention group receiving standard clinical care plus structured VR sessions, or a control group receiving standard clinical care alone. Agitation scores and vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) are measured pre- and post-intervention to evaluate the outcomes of VR therapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Stroke is a sudden medical condition that affects the brain. During the acute phase of a stroke, many patients experience agitation, which means feeling restless, anxious, or uncooperative. Agitation can complicate medical care and negatively affect a patient's recovery and vital signs (such as heart rate and blood pressure).

The main purpose of this study is to evaluate whether using a Virtual Reality (VR) application helps reduce agitation levels and stabilize vital signs in individuals who have experienced an acute stroke.

This is a randomized controlled, single-blind clinical trial. Participants with acute stroke will be randomly assigned to one of two groups:

Intervention Group: Participants will receive a structured Virtual Reality (VR) application session in addition to their routine stroke care.

Control Group: Participants will receive standard routine clinical care and monitoring without the VR application.

Researchers will measure and compare the participants' agitation levels using a clinical evaluation scale before and after the intervention. In addition, physiological vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation) will be closely monitored to determine the effects of the VR therapy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

68

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

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:

  • * Individuals who have passed 48 hours post-acute CVA (being in the acute phase of stroke treatment, stroke duration not exceeding the first 4 weeks)

    • Having a score of 0 on the Wong-Baker FACES Pain Rating Scale
    • Having a score of at least +2 or higher on the Richmond Agitation-Sedation Scale (RASS)
    • Being 18 years of age or older
    • Having a GCS score of 13 or higher
    • Having no hearing or visual impairments
    • Not being in contact isolation due to a contagious disease
    • Being literate in Turkish
    • Not being administered sedation
    • Being awake and hemodynamically stable
    • Being able to sit in high Fowler's position
    • Individuals without mechanical ventilation support

Exclusion Criteria:

  • Presence of nausea and vomiting

    • Mobility restriction and sensitivity to claustrophobia
    • Presence of delirium
    • Presence of schizophrenia and dementia
    • Presence of vertigo and Meniere's disease
    • Having a pain score of 1 point or higher
    • Having facial damage to the extent that a virtual reality headset cannot be worn

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention Group
Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management.
Conductual: Virtual Reality Application
Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.
Comparador activo: Control Group
Participants in this arm receive standard routine clinical stroke care and monitoring alone, without any Virtual Reality intervention.
Otro: Standard Care (in control arm)
Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Temperature
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Assessment of body temperature (°C) evaluated across three time points.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Heart Rate
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Assessment of heart rate (beats/min) evaluated across three time points.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Blood Pressure
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Assessment of blood pressure (mmHg) evaluated across three time points.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Respiratory Rate
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Assessment of respiratory rate (breaths/min) evaluated across three time points.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Oxygen Saturation
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Assessment of oxygen saturation (SpO2, %) evaluated across three time points.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Agitation Levels
Periodo de tiempo: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Agitation levels evaluated using a validated clinical agitation rating scale across three time points (pre-intervention, immediately post-intervention, and post-intervention) to assess changes in patient agitation.
Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ankara Etlik City Hospital

Colaboradores

Çankırı Karatekin University

Investigadores

  • Director de estudio: Seher Gönen Şentürk, PhD, Çankırı Karatekin University, Faculty of Health Sciences

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)

8 de septiembre de 2025

Finalización primaria (Actual)

16 de junio de 2026

Finalización del estudio (Actual)

20 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

18 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de agosto de 2026

Publicado por primera vez (Actual)

26 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ÇAKÜ-SBF-NCD-01
  • SBF111224L11 (Otro número de subvención/financiamiento: Cankiri Karatekin University)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with ethical board guidelines and informed consent agreements.

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. .

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