Pain Clinical Trial - Virtual Reality Pain Neuroscience Education for

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04470375
Study type	Interventional
Source	University of South Dakota
Contact
Status	Completed
Phase	N/A
Start date	August 4, 2020
Completion date	August 5, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Virtual Reality Pain Neuroscience Education for Middle School Students

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms