Procedural PainVR-PEDNCT07740850
Virtual Reality for Procedural Pain During IV Cannulation in Children
A study testing Virtual Reality-Based Distraction in people with Procedural Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether virtual reality (VR)-based distraction can reduce pain during intravenous cannulation and venous blood sampling in children treated in a pediatric emergency department. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Virtual Reality-Based Distraction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2024to 22 Jan 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-11 years
- Requirement for intravenous cannulation or venous blood sampling in the -pediatric emergency department
- Ability to understand and engage with virtual reality content
- Written informed consent obtained from parent or legal guardian
Who cannot join
- Visual or hearing impairment preventing VR use
- Neurological or developmental disorders affecting communication or cooperation
- Altered level of consciousness
- Hemodynamic instability requiring immediate intervention
- Previous participation in the study
- Refusal of participation by the child or parent/legal guardian
- Contraindications to virtual reality exposure (e.g., severe motion sickness or intolerance)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Virtual Reality Distraction on Procedural Pain, Duration, and Parental Satisfaction During Intravenous Cannulation and Blood Sampling in the Pediatric Emergency Department: A Prospective Quasi-Experimental Study
This study evaluates whether virtual reality (VR)-based distraction can reduce pain during intravenous cannulation and venous blood sampling in children treated in a pediatric emergency department. Children aged 6-11 years who required these procedures received either standard care or VR distraction using age-appropriate audiovisual content. The primary outcome was procedure-related pain measured by the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, and parental satisfaction. The study also explored whether the effectiveness of VR was associated with patient engagement during the procedure.
Read the detailed description
Painful procedures such as intravenous cannulation and venous blood sampling are common in pediatric emergency departments and may lead to distress, anxiety, and negative healthcare experiences. Virtual reality (VR) has emerged as a non-pharmacological intervention that may reduce procedural pain through immersive distraction.
This prospective quasi-experimental study was conducted in a tertiary pediatric emergency department between September 2024 and September 2025. A total of 150 children aged 6-11 years requiring intravenous cannulation or venous blood sampling were included. Participants were enrolled sequentially, with 100 children assigned to the VR group and 50 to standard care. The VR intervention consisted of age-appropriate audiovisual content delivered through a VR headset during the procedure.
The primary outcome was procedure-related pain measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, parental satisfaction, and VR response. The study aimed to assess whether VR distraction may improve procedural experience and reduce procedure-related pain in pediatric emergency settings.
- Conditions
- Procedural Pain
- Being tested
- Virtual Reality-Based Distraction
- Keywords
- Virtual Reality, Pediatric Emergency Department, Procedural Pain, Intravenous Cannulation, Venous Blood Sampling, Pain Management, Distraction Therapy
- Medical subject headings
- Pain, Procedural, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based DistractionDevice
Participants received age-appropriate audiovisual distraction through a virtual reality headset (Meta Quest 3S) during intravenous cannulation or venous blood sampling. The intervention aimed to reduce procedural pain and distress by redirecting attention away from the procedure toward immersive VR content.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Children received age-appropriate audiovisual distraction through a virtual reality headset during intravenous cannulation or venous blood sampling procedures. Receives: Device: Virtual Reality-Based Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related pain
Procedure-related pain assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) following intravenous cannulation or venous blood sampling.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start13 Sep 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muazzez Seker Gezici, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740850
- Sponsor's protocol ID
- EGE-ETHICS-22-5.1T-33
- Other IDs
- Project No: 32350
- Acronym
- VR-PED
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared because the study includes pediatric participants, and data sharing may increase the risk of participant re-identification. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional ethics approval and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Distraction on Procedural Pain, Duration, and Parental Satisfaction During Intravenous Cannulation and Blood Sampling in the Pediatric Emergency Department: A Prospective Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07740850
- Acronym / sponsor ID
- VR-PED / EGE-ETHICS-22-5.1T-33
- Conditions
- Procedural Pain
- Keywords
- Virtual Reality, Pediatric Emergency Department, Procedural Pain, Intravenous Cannulation, Venous Blood Sampling, Pain Management, Distraction Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 3 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 study evaluates whether virtual reality (VR)-based distraction can reduce pain during intravenous cannulation and venous blood sampling in children treated in a pediatric emergency department. Children aged 6-11 years who required these procedures received either standard care or VR distraction using age-appropriate audiovisual content. The primary outcome was procedure-related pain measured by the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, and parental satisfaction. The study also explored whether the effectiveness of VR was associated with patient engagement during the procedure.
Detailed description
Painful procedures such as intravenous cannulation and venous blood sampling are common in pediatric emergency departments and may lead to distress, anxiety, and negative healthcare experiences. Virtual reality (VR) has emerged as a non-pharmacological intervention that may reduce procedural pain through immersive distraction.
This prospective quasi-experimental study was conducted in a tertiary pediatric emergency department between September 2024 and September 2025. A total of 150 children aged 6-11 years requiring intravenous cannulation or venous blood sampling were included. Participants were enrolled sequentially, with 100 children assigned to the VR group and 50 to standard care. The VR intervention consisted of age-appropriate audiovisual content delivered through a VR headset during the procedure.
The primary outcome was procedure-related pain measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, parental satisfaction, and VR response. The study aimed to assess whether VR distraction may improve procedural experience and reduce procedure-related pain in pediatric emergency settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality-Based DistractionChildren received age-appropriate audiovisual distraction through a virtual reality headset during intravenous cannulation or venous blood sampling procedures. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-11 years
- Requirement for intravenous cannulation or venous blood sampling in the -pediatric emergency department
- Ability to understand and engage with virtual reality content
- Written informed consent obtained from parent or legal guardian
Key exclusion criteria (7 listed)
- Visual or hearing impairment preventing VR use
- Neurological or developmental disorders affecting communication or cooperation
- Altered level of consciousness
- Hemodynamic instability requiring immediate intervention
- Previous participation in the study
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-Based DistractionParticipants received age-appropriate audiovisual distraction through a virtual reality headset (Meta Quest 3S) during intravenous cannulation or venous blood sampling. The intervention aimed to reduce procedural pain and distress by redirecting attention away from the procedure toward immersive VR content. | Device | Virtual Reality Group |
Primary outcome
Procedure-related pain
Time frame: Immediately after the procedure
Procedure-related pain assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) following intravenous cannulation or venous blood sampling.
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 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared because the study includes pediatric participants, and data sharing may increase the risk of participant re-identification. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional ethics approval and applicable regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Based Distraction in people with Procedural Pain, run by Ege 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 4 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 3 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?
Procedure-related pain (time frame: Immediately after the procedure). 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 Aug 2026.