ClinicalTrials.gg
CompletedNCT07787910Updated Aug 26, 2026

Effect of Virtual Reality on Agitation in Acute Stroke

An interventional study of Virtual Reality Application and Standard Care (in control arm) in Acute Stroke and Psychomotor Agitation, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2025, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 484 studies in Stroke with a site in Turkey — 95 open to participants now, 107 under way, 3 of them phase 3. Stroke · Turkey.

Enrollment
63rd of 320
68 · median 40
Started
2025
with 70 others
No phase
291 of 484
57 open now
Registered
472nd of 484
by date

Among the 484 studies in Stroke with a site in Turkey, this one is the 63rd largest by enrollment of the 320 interventional ones that give a count, is one of 71 that started in 2025, is one of 291 with no phase, and was the 472nd registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

95 of the 484 studies in Stroke with a site in Turkey are open now. Recruiting first, the newest first:

90 more — sign in →

All 95 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Acute Stroke
  • Psychomotor Agitation

Keywords

  • Acute stroke
  • Virtual reality
  • Agitation
  • Neurological intensive care
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • 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

  • 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)

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 site
  • Çankırı Karatekin University
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Jun 2026, 9 months.

Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 9 months is below that.

Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 26, 2026
StartActual
Sep 8, 2025
Primary completionActual
Jun 16, 2026
CompletionActual
Jun 20, 2026
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07787910
Collaborators
Çankırı Karatekin University
Responsible party
Nazlı Can Denizhan (Nurse and Master Student, Çankırı Karatekin University) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 8, 2025
Primary completion
Jun 16, 2026
Completion
Jun 20, 2026
Last update
Aug 26, 2026

Study contacts

Seher Gönen Şentürk, PhD
study director · Çankırı Karatekin University, Faculty of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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