Procedural PainNCT07763132
Comparison of Virtual Reality, EMLA Cream, and Standard Care for Pain During Blood Draws in Children
A study testing Virtual Reality Distraction and Lidocaine-Prilocaine Cream in people with Procedural Pain, run by Marie Lulková at 1 site in Czechia.
Trial summary
This randomized controlled trial evaluates methods to reduce pain during venipuncture in children aged 3 to 15 years. The study compares three approaches: virtual reality distraction using a VR headset, topical anesthesia with EMLA cream, and standard care without an additional pain-reducing intervention. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Virtual Reality Distraction and Lidocaine-Prilocaine Cream
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 15 years.
- Clinical indication for venipuncture.
- Written informed consent provided by a parent or legal guardian and verbal or written assent from the child, as appropriate for age and cognitive ability.
Who cannot join
- Known hypersensitivity to local anesthetics.
- Diagnosed mental disorder.
- Current treatment with analgesic or anxiolytic medications.
- Venipuncture not successful on the first attempt.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Ústí nad Labem Region, 40011
Marie Lulková, Mgr., +420733756630, marie.lulkova@kzcr.eu
About this study
Official title: Comparison of the Efficacy of Virtual Reality and Topical Anesthetic During Venipuncture in Children: a Randomized Controlled Trial
This randomized controlled trial evaluates methods to reduce pain during venipuncture in children aged 3 to 15 years. The study compares three approaches: virtual reality distraction using a VR headset, topical anesthesia with EMLA cream, and standard care without an additional pain-reducing intervention. The main question is whether virtual reality reduces pain during venipuncture more effectively than EMLA cream or standard care. Pain is assessed immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10). The planned study sample includes 450 children.
- Conditions
- Procedural Pain
- Being tested
- Virtual Reality Distraction, Lidocaine-Prilocaine Cream
- Keywords
- Venipuncture, Virtual Reality, EMLA Cream, Topical Anesthesia, Pediatric Pain, Children, Distraction
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
Virtual reality distraction is provided during venipuncture using a Meta Quest 3 headset. All participants assigned to this intervention view the same 360° wildlife video. Children can change the direction of view by moving their head but cannot control the content or sequence of the video. The headset is used throughout the venipuncture procedure.
Lidocaine-Prilocaine CreamDrug
Topical EMLA cream containing lidocaine and prilocaine is applied to the planned venipuncture site, covered with an occlusive dressing, and left in place for at least 60 minutes before venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Children assigned to this arm receive virtual reality distraction during venipuncture using a Meta Quest 3 headset. The same 360° wildlife video is presented to all participants. Children can change the direction of view by moving their head but cannot control the content or sequence of the video. The headset is used throughout the venipuncture procedure. Receives: Behavioral: Virtual Reality Distraction |
| EMLA Cream | Active comparator | Children assigned to this arm receive topical EMLA cream containing lidocaine and prilocaine at the planned venipuncture site. The application site is covered with an occlusive dressing, and the cream is left in place for at least 60 minutes before venipuncture. Receives: Drug: Lidocaine-Prilocaine Cream |
| Standard Care | No intervention | Children assigned to this arm receive standard nursing care during venipuncture according to routine clinical practice. No additional pharmacological or non-pharmacological intervention specifically aimed at reducing procedural pain is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Venipuncture
Pain intensity is self-reported immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst pain. Lower scores indicate lower perceived pain intensity.
Measured: Immediately after venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marie Lulková
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marie Lulková, Jan Evangelista Purkyne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763132
- Sponsor's protocol ID
- 321/1
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Virtual Reality and Topical Anesthetic During Venipuncture in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07763132
- Acronym / sponsor ID
- 321/1
- Conditions
- Procedural Pain
- Keywords
- Venipuncture, Virtual Reality, EMLA Cream, Topical Anesthesia, Pediatric Pain, Children, Distraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Marie LulkováUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 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 trial evaluates methods to reduce pain during venipuncture in children aged 3 to 15 years. The study compares three approaches: virtual reality distraction using a VR headset, topical anesthesia with EMLA cream, and standard care without an additional pain-reducing intervention. The main question is whether virtual reality reduces pain during venipuncture more effectively than EMLA cream or standard care. Pain is assessed immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10). The planned study sample includes 450 children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Reality DistractionChildren assigned to this arm receive virtual reality distraction during venipuncture using a Meta Quest 3 headset. The same 360° wildlife video is presented to all participants. Children can change the direction of view by moving their head but cannot control the content or sequence of the video. The headset is used throughout the venipuncture procedure. |
| EMLA Cream | Active comparator | Drug: Lidocaine-Prilocaine CreamChildren assigned to this arm receive topical EMLA cream containing lidocaine and prilocaine at the planned venipuncture site. The application site is covered with an occlusive dressing, and the cream is left in place for at least 60 minutes before venipuncture. |
| Standard Care | No intervention | –Children assigned to this arm receive standard nursing care during venipuncture according to routine clinical practice. No additional pharmacological or non-pharmacological intervention specifically aimed at reducing procedural pain is provided. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 to 15 years.
- Clinical indication for venipuncture.
- Written informed consent provided by a parent or legal guardian and verbal or written assent from the child, as appropriate for age and cognitive ability.
Key exclusion criteria (4 listed)
- Known hypersensitivity to local anesthetics.
- Diagnosed mental disorder.
- Current treatment with analgesic or anxiolytic medications.
- Venipuncture not successful on the first attempt.
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 DistractionVirtual reality distraction is provided during venipuncture using a Meta Quest 3 headset. All participants assigned to this intervention view the same 360° wildlife video. Children can change the direction of view by moving their head but cannot control the content or sequence of the video. The headset is used throughout the venipuncture procedure. | Behavioural | Virtual Reality |
| Lidocaine-Prilocaine CreamTopical EMLA cream containing lidocaine and prilocaine is applied to the planned venipuncture site, covered with an occlusive dressing, and left in place for at least 60 minutes before venipuncture. | Drug | EMLA Cream |
Primary outcome
Pain Intensity During Venipuncture
Time frame: Immediately after venipuncture
Pain intensity is self-reported immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst pain. Lower scores indicate lower perceived pain intensity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
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 Distraction and Lidocaine-Prilocaine Cream in people with Procedural Pain, run by Marie Lulková at 1 site in Czechia.
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 4 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: looking for participants now, as of the sponsor's last update on 13 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Lulková, Mgr. (+420733756630, marie.lulkova@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Venipuncture (time frame: Immediately after venipuncture). 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 13 Aug 2026.