Clinical trial NCT04470375: Virtual Reality Pain Neuroscience Education for Middle School Students
Official title: Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Education
Virtual Reality
Lead sponsor: University of South Dakota
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group of students receiving Virtual Reality education
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later
timeFrame: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR
measure: Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later
timeFrame: Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention
measure: Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later
timeFrame: Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Evidence in Motion (Lake Forest Country Clug)
state: Kentucky
Study officials:
affiliation: University of South Dakota
name: Kory J Zimney, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: