Virtual Reality Pain Neuroscience Education for Middle School Students

Study Overview
=================
Brief Summary
-----------------
Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform with middle school students. The investigators have previously studied the use of PNE with in person educational sessions with middle school kids and video recorded sessions. This study will be looking into utilizing the VR platform for delivery of the educational information.

Detailed Description
-----------------
Potential middle school students will be contacted through fliers to local parents in the Louisville, KY area via various sports team events. The investigators have secured a meeting room space at a large reception room at Lake Forest Country Club (Louisville, KY) on August 4, 2020. Potential participants will call to schedule time for participation to allow for proper staggering of participants arriving on the day of data collection. Research team will set up informed consent space at the entrance to the reception room and stagger participant arrival time to reduce contact with other participants. This space will be cleaned and disinfected regularly during the consenting process as new participants arrive. Once student and parent arrives they will complete informed consent and COVID-19 screening form before being allowed into research space (reception room). Each participant will be given a pen to keep during the research study and go home with also provided with hand sanitizer to use before and after. No pens will be reused with other participants. Masks will be made available for anyone that requests one, but they will not be required while at the testing location. Parents of child will be allowed to sit in waiting chair keeping 6 feet of distance from anyone else. The child research participant will be lead to a chair in the room and complete pre-test questionnaire and then they will be set-up with a Virtual Reality (VR) device (cleaned and disinfected between each use) and go through a VR educational experience ( 30 minutes) on Pain Neuroscience Education (PNE). Upon completion of the VR educational session they will complete post-test questionnaire and then be able to leave.

Official Title
-----------------
Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs

Conditions
-----------------
Pain, Education, Virtual Reality

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality Pain Neuroscience Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to view VR educational session in grades 5, 6, 7, or 8. Exclusion Criteria: has been through PNE educational program previously aversion to VR or problems with viewing VR in the past history of epilepsy or seizures eye surgery or injury within the last 6 months open sores or wounds around where VR googles are worn on face anyone who has had a concussion that has not been cleared for full activity or experiencing any post-concussion syndrome symptoms currently.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group of students receiving Virtual Reality education
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR pain education<br>Students receiving the 45 minute pain education through Virtual Reality | Behavioral: Virtual Reality Pain Neuroscience Education<br>* Use of virtual reality media to provide pain neuroscience education<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | Pain beliefs questionnaire: 11 point Likert scale (0= strongly disagree, 10= strongly agree) on 5 pain beliefs questions. Some questions are positively worded so higher scores = more positive beliefs (#1, 4, 5). Some are negatively worded so higher scores = worse beliefs (#2, 3) question 1 - Pain is normal; without being able to feel pain you will not survive question 2 - Pain means something is wrong with your tissues question 3 - Pain always means you have to stop what you are doing question 4 - You can control how much pain you feel question 5 - Your brain decides if you feel pain, not your tissues | Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR | 
| Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later | 12 true false questions, higher scores of correct answers demonstrate higher pain knowledge. 12 points is highest score, 0 points is lowest score | Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention | 
| Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | 7 point Likert scale (0= completely disagree, 6=completely agree), 5 questions (question 1-Physical activity may cause pain, question 2-Physical activity makes pain worse, question 3-Physical activity might harm my tissues if I am hurting, question 4-Physical activity should not be done if it increases pain, question 5-Physical activities cannot be done if it makes pain worse). The higher the score the higher the fear avoidance beliefs. Lowest score 0, highest score 30. | Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes |