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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
68
Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.
Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.
Çankırı Karatekin University
Ankara, Turkey (Türkiye)
Change in Body Temperature
Assessment of body temperature (°C) evaluated across three time points.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Heart Rate
Assessment of heart rate (beats/min) evaluated across three time points.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Blood Pressure
Assessment of blood pressure (mmHg) evaluated across three time points.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Respiratory Rate
Assessment of respiratory rate (breaths/min) evaluated across three time points.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Oxygen Saturation
Assessment of oxygen saturation (SpO2, %) evaluated across three time points.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Change in Agitation Levels
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.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
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