Procedural Anxiety, Procedural Pain
Conditions
Keywords
Laser, Dermatology, Virtual Reality, VR
Brief 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. 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.
Interventions
OTHERVR-PAT
Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Researcher conducting the post-procedural survey is blinded to the group assignment
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in procedural pain | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported VR experience | Immediately following laser procedure in VR-PAT group | 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. |
| Nurse-reported utility | Immediately following laser procedure in VR-PAT group | Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHenry Xiang, MD, MPH, PhD, MBA
Nationwide Children's Hospital
Outcome results
None listed