An interventional study of VR-PAT in Procedural Anxiety and Procedural Pain, sponsored by Nationwide Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 5 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Supportive care
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 65 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.
Other: VR-PAT
Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.
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.
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Immediately following laser procedure in VR-PAT group
Plan to share: No
Ran from Jan 2023 to primary completion in Nov 2025, 34 months.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 34 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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