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NCT Number: NCT07787910

Effect of Virtual Reality on Agitation in Acute Stroke

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.

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Key information

Conditions

Acute Stroke Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çankırı Karatekin University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Application

Behavioral

Participants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation.

Standard Care (in control arm)

Other

Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention.

Primary outcomes

  1. Change in Body Temperature

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

    Assessment of body temperature (°C) evaluated across three time points.

  2. Change in Heart Rate

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

    Assessment of heart rate (beats/min) evaluated across three time points.

  3. Change in Blood Pressure

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

    Assessment of blood pressure (mmHg) evaluated across three time points.

  4. Change in Respiratory Rate

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

    Assessment of respiratory rate (breaths/min) evaluated across three time points.

  5. Change in Oxygen Saturation

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention

    Assessment of oxygen saturation (SpO2, %) evaluated across three time points.

  6. Change in Agitation Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Collaborators

  • Çankırı Karatekin University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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