Procedural AnxietyNCT05645224
VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures
A study testing VR-PAT in people with Procedural Anxiety and Procedural Pain, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- VR-PAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 31 Dec 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser
- have a legal guardian present for patients less than 18 years old for the procedure (for informed consent)
- can communicate orally
Who cannot join
- any wounds that may interfere with study procedures
- usage of a diode laser (VR safety has not been established yet)
- vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- minors in foster care
- unable to communicate in English
- pregnant women
- prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures
This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.
Read the detailed description
In this three-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group, control group (same VR google without game), or standard of care at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure. VR versus Control and VR versus Standard of Care will be compared.
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- VR-PAT
- Keywords
- Laser, Dermatology, Virtual Reality, VR
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-PATOther
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
| Study group | Role | What they receive |
|---|---|---|
| VR-PAT | Experimental | Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game. Receives: Other: VR-PAT |
| Control | No intervention | Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on. |
| Standard of Care | No intervention | This will be a standard of care group that will match the current clinic practices. Subjects will wear the standard protective eyewear and offered current distraction options. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in procedural pain
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported (if <18 years)), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
Measured: Assessed immediately following each laser procedure
Change in procedural anxiety
Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.
Measured: Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure
Secondary outcomes (2)
Self-reported VR experience
0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.
Measured: Immediately following laser procedure in VR-PAT group
Nurse-reported utility
Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure.
Measured: Immediately following laser procedure in VR-PAT group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start9 Jan 2023
- Primary completion14 Nov 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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
- Crossover
- Model description
- Participants will be randomly assigned to either the intervention group (VR-PAT) the control group (same VR google without game), or standard of care at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. VR versus Control and VR versus Standard of Care will be compared.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
- Investigators
- Henry Xiang, MD, MPH, PhD, MBA, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645224
- Sponsor's protocol ID
- STUDY00002880
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong M, Williams H, Fernandez Faith E, Ni A, Xiang H. Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Protocol for a Pilot Randomized Clinical Trial. JMIR Res Protoc. 2026 Jun 9;15:e87207. doi: 10.2196/87207.
PubMed 42263172
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures
- ClinicalTrials.gov ID
- NCT05645224
- Acronym / sponsor ID
- STUDY00002880
- Conditions
- Procedural Anxiety, Procedural Pain
- Keywords
- Laser, Dermatology, Virtual Reality, VR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2022 (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 will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.
Detailed description
In this three-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group, control group (same VR google without game), or standard of care at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure. VR versus Control and VR versus Standard of Care will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to either the intervention group (VR-PAT) the control group (same VR google without game), or standard of care at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. VR versus Control and VR versus Standard of Care will be compared.
| Arm | Type | Receives |
|---|---|---|
| VR-PAT | Experimental | Other: VR-PATParticipant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game. |
| Control | No intervention | –Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on. |
| Standard of Care | No intervention | –This will be a standard of care group that will match the current clinic practices. Subjects will wear the standard protective eyewear and offered current distraction options. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser
- have a legal guardian present for patients less than 18 years old for the procedure (for informed consent)
- can communicate orally
Key exclusion criteria (8 listed)
- any wounds that may interfere with study procedures
- usage of a diode laser (VR safety has not been established yet)
- vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- minors in foster care
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 |
|---|---|---|
| VR-PATVirtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device | Other | VR-PAT |
Primary outcome
Change in procedural pain
Time frame: Assessed immediately following each laser procedure
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported (if <18 years)), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
Change in procedural anxiety
Time frame: Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure
Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.
2 secondary outcomes
Self-reported VR experience
Time frame: Immediately following laser procedure in VR-PAT group
Nurse-reported utility
Time frame: Immediately following laser procedure in VR-PAT group
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 27 Aug 2026.
- Background: PubMed 42263172Armstrong M, Williams H, Fernandez Faith E, Ni A, Xiang H. Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Protocol for a Pilot Randomized Clinical Trial. JMIR Res Protoc. 2026 Jun 9;15:e87207. doi: 10.2196/87207.
- 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.
Henry Xiang, MD, MPH, PhD, MBA principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-PAT in people with Procedural Anxiety and Procedural Pain, run by Nationwide Children's Hospital at 1 site in United States.
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 8 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: enrolling by invitation, as of the sponsor's last update on 27 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 United States. 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?
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 procedural pain (time frame: Assessed immediately following each laser procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645224, which also lists 1 linked publication.
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 27 Aug 2026.