Acute Stroke, Psychomotor Agitation
Conditions
Keywords
Acute stroke, Virtual reality, Agitation, Neurological intensive care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual Reality Application
Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.
OTHERStandard Care (in control arm)
Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.
Sponsors
Ankara Etlik City Hospital
Çankırı Karatekin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
A single-blind design is utilized in this trial. Participants are blinded to their group assignment (Intervention vs. Control) to minimize performance and reporting bias during the study procedures.
Intervention model description
Participants are allocated into two parallel groups (Intervention Group and Control Group) in a 1:1 ratio using a stratified randomization method to ensure baseline homogeneity. Participants are blinded to their group assignment. The intervention group receives standard clinical stroke care combined with structured Virtual Reality (VR) application sessions, while the control group receives standard clinical stroke care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Temperature | Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention | Assessment of body temperature (°C) evaluated across three time points. |
| Change in Heart Rate | Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention | Assessment of heart rate (beats/min) evaluated across three time points. |
| Change in Blood Pressure | Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention | Assessment of blood pressure (mmHg) evaluated across three time points. |
| Change in Respiratory Rate | Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention | Assessment of respiratory rate (breaths/min) evaluated across three time points. |
| Change in Oxygen Saturation | Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention | Assessment of oxygen saturation (SpO2, %) evaluated across three time points. |
| Change in Agitation Levels | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORSeher Gönen Şentürk, PhD
Çankırı Karatekin University, Faculty of Health Sciences
Outcome results
None listed