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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 two-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group or control group (same VR google without game) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-PAT | Experimental | Participant 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-PAT | Other | Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately following laser procedure in VR-PAT group |
| Nurse-reported utility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Xiang, MD, MPH, PhD, MBA | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomly assigned to either the intervention group (VR-PAT) or the control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure.
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Researcher conducting the post-procedural survey is blinded to the group assignment
Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure. |
| Immediately following laser procedure in VR-PAT group |