Acute StrokeNCT07787910
Effect of Virtual Reality on Agitation in Acute Stroke
A study testing Virtual Reality Application in people with Acute Stroke and Psychomotor Agitation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Stroke, Psychomotor Agitation
- What is being tested?
- Virtual Reality Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Acute Stroke, Psychomotor Agitation
- Being tested
- Virtual Reality Application, Standard Care (in control arm)
- Keywords
- Acute stroke, Virtual reality, Agitation, Neurological intensive care
- Medical subject headings
- Stroke, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management. Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Temperature
Assessment of body temperature (°C) evaluated across three time points.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start8 Sep 2025
- Primary completion16 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Principal investigator, Nazlı Can Denizhan, Çankırı Karatekin University
- Investigators
- Seher Gönen Şentürk, PhD, Study director, Çankırı Karatekin University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787910
- Sponsor's protocol ID
- ÇAKÜ-SBF-NCD-01
- Other IDs
- SBF111224L11
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Agitation in Individuals With Acute Stroke: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT07787910
- Acronym / sponsor ID
- ÇAKÜ-SBF-NCD-01
- Conditions
- Acute Stroke, Psychomotor Agitation
- Keywords
- Acute stroke, Virtual reality, Agitation, Neurological intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Collaborators
- Çankırı Karatekin University
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Virtual Reality ApplicationParticipants in this arm receive structured Virtual Reality (VR) application sessions in addition to standard clinical stroke care and management. |
| Control Group | Active comparator | Other: Standard Care (in control arm)Participants in this arm receive standard routine clinical stroke care and monitoring alone, without any Virtual Reality intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- * 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)
Key exclusion criteria (7 listed)
- Presence of nausea and vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ApplicationParticipants receive structured Virtual Reality (VR) relaxation and distraction sessions in addition to standard clinical stroke care to manage post-stroke agitation. | Behavioural | Intervention Group |
| Standard Care (in control arm)Participants receive routine standard clinical stroke care and monitoring alone without any Virtual Reality intervention. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seher Gönen Şentürk, PhD study director
Çankırı Karatekin University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Application in people with Acute Stroke and Psychomotor Agitation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Temperature (time frame: Baseline (pre-intervention), immediately post-intervention, and 1 hour post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.