Virtual Reality Pain Neuroscience Education for Middle School Students

NCT04470375 | Completed Results

• 1 other identifier: USD-IRB-20-129
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Education; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

VR pain education

EXPERIMENTAL

Students receiving the 45 minute pain education through Virtual Reality

Behavioral: Virtual Reality Pain Neuroscience Education

Interventions

Virtual Reality Pain Neuroscience Education BEHAVIORAL

Use of virtual reality media to provide pain neuroscience education

VR pain education

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• willing to view VR educational session
• in grades 5, 6, 7, or 8.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Dakota: lead

Study Sites (1)

Evidence in Motion (Lake Forest Country Clug)

Louisville, Kentucky, 40245, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kory Zimney
• Organization: University of South Dakota

kory.zimney@usd.edu

16056586373

Study Officials

• Kory J Zimney, PT, DPT

  University of South Dakota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: single group of students receiving Virtual Reality education

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: August 4, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: February 5, 2021
• Results First Posted: December 22, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)