PainOculus2NCT07261410
Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety
A study testing active VR distraction and passive VR distraction in people with Pain and Anxiety State, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain, Anxiety State, Venipuncture
- What is being tested?
- active VR distraction and passive VR distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Apr 2025
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child agrees to participate in the study voluntarily.
- The parent agrees to participate in the study voluntarily.
- Obtaining consent forms from the child and parent
Who cannot join
- The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
- Having fever (>37.5C) and severe dehydration
- The patient did not take analgesics before the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety During Venipuncture
This study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture.
Read the detailed description
Participants were assigned to three groups through stratified randomization: the active VR, the passive VR, and the control group. Children in the VR groups wore VR goggles (Oculus Quest 2) during venipuncture.
- Conditions
- Pain, Anxiety State, Venipuncture
- Being tested
- active VR distraction, passive VR distraction
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active VR distractionDevice
The remote control of the virtual glasses will be given to the hand, and the child will start, slow down or stop the application herself.
passive VR distractionDevice
watching the application by wearing virtual glasses with Oculus Guest 2
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standart care |
| Active VR | Experimental | The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications. Receives: Device: active VR distraction |
| Passive VR | Experimental | It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application with Oculus Guest 2 that will attract the attention of children was determined by the researchers. Receives: Device: passive VR distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure related pain
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
Measured: 3 minutes after the phlebotomy
procedure related anxiety
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Measured: 3 minutes after the phlebotomy
procedure related emotional apperance
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors
Measured: immediately after the phlebotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261410
- Sponsor's protocol ID
- VRdeuOculus2
- Acronym
- Oculus2
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety During Venipuncture
- ClinicalTrials.gov ID
- NCT07261410
- Acronym / sponsor ID
- Oculus2 / VRdeuOculus2
- Conditions
- Pain, Anxiety State, Venipuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 Dec 2025 (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 study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture.
Detailed description
Participants were assigned to three groups through stratified randomization: the active VR, the passive VR, and the control group. Children in the VR groups wore VR goggles (Oculus Quest 2) during venipuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standart care |
| Active VR | Experimental | Device: active VR distractionThe remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications. |
| Passive VR | Experimental | Device: passive VR distractionIt was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application with Oculus Guest 2 that will attract the attention of children was determined by the researchers. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child agrees to participate in the study voluntarily.
- The parent agrees to participate in the study voluntarily.
- Obtaining consent forms from the child and parent
Key exclusion criteria (3 listed)
- The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
- Having fever (>37.5C) and severe dehydration
- The patient did not take analgesics before the intervention
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 |
|---|---|---|
| active VR distractionThe remote control of the virtual glasses will be given to the hand, and the child will start, slow down or stop the application herself. | Device | Active VR |
| passive VR distractionwatching the application by wearing virtual glasses with Oculus Guest 2 | Device | Passive VR |
Primary outcome
procedure related pain
Time frame: 3 minutes after the phlebotomy
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
procedure related anxiety
Time frame: 3 minutes after the phlebotomy
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
procedure related emotional apperance
Time frame: immediately after the phlebotomy
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors
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 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Gülçin Özalp Gerçeker, Prof. principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active VR distraction and passive VR distraction in people with Pain and Anxiety State, run by Dokuz Eylul University 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 3 inclusion and 3 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 3 Dec 2025. 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?
procedure related pain (time frame: 3 minutes after the phlebotomy). The study lists 3 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 3 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.