Effect of Virtual Reality on Agitation in Acute Stroke

NCT07787910 | Completed

• 2 other identifiers: ÇAKÜ-SBF-NCD-01SBF111224L11
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Psychomotor Agitation

Keywords

Acute stroke; Virtual reality; Agitation; Neurological intensive care

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management.

Behavioral: Virtual Reality Application

Control Group

ACTIVE COMPARATOR

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

Other: Standard Care (in control arm)

Interventions

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.

Intervention Group

Standard Care (in control arm) OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead
• Çankırı Karatekin University: collaborator

Study Sites (1)

Çankırı Karatekin University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Psychomotor Agitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Seher Gönen Şentürk, PhD

  Çankırı Karatekin University, Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse and Master Student

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start: September 8, 2025
• Primary Completion: June 16, 2026
• Study Completion: June 20, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)