Effect of Virtual Reality on Agitation in Acute Stroke

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.

Study Overview

• Status: Completed
• Conditions: Psychomotor Agitation; Acute Stroke
• Intervention / Treatment: Behavioral: Virtual Reality Application; Other: Standard Care (in control arm)

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Çankırı Karatekin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management.	Behavioral: 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.
Active Comparator: Control Group; Participants in this arm receive standard routine clinical stroke care and monitoring alone, without any Virtual Reality intervention.	Other: Standard Care (in control arm); Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Temperature	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Collaborators: Çankırı Karatekin University
• Investigators: Study Director: Seher Gönen Şentürk, PhD, Çankırı Karatekin University, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Actual): June 16, 2026
• Study Completion (Actual): June 20, 2026

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 23, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Virtual reality; Agitation; Acute stroke; Neurological intensive care
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Stroke; Psychomotor Agitation; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: ÇAKÜ-SBF-NCD-01; SBF111224L11 (Other Grant/Funding Number: Cankiri Karatekin University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No