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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR pain education | Experimental | Students receiving the 45 minute pain education through Virtual Reality |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Pain Neuroscience Education | Behavioral | Use of virtual reality media to provide pain neuroscience education |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kory J Zimney, PT, DPT | University of South Dakota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidence in Motion (Lake Forest Country Clug) | Louisville | Kentucky | 40245 | United States |
Data will be stored for required 3 year period after study. No intent at this time to share data.
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No exclusion prior to assignment
Middle school students (Grades 5-8), live in Louisville, KY area, no PNE training sessions in the past, no history of epilepsy or seizures or adverse events with viewing VR in the past.
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| ID | Title | Description |
|---|---|---|
| FG000 | Middle School VR Students | Middle school students viewing the VR on PNE |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Middle school students
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| ID | Title | Description |
|---|---|---|
| BG000 | Middle School VR Students | Middle school students viewing the VR on PNE |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR |
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Adverse events were assessed for from the start of Virtual reality during the entire educational session (approximately 45 minutes) and then after completion of the VR educational experience for 15 minutes while the completed the ending data collection. 1 hour total time.
any episode of ill feeling while performing the VR or immediately (15 minutes) after performing VR
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Middle School VR Students | Middle school students viewing the VR on PNE | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kory Zimney | University of South Dakota | 16056586373 | kory.zimney@usd.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2020 | Nov 25, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2020 | Nov 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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single group of students receiving Virtual Reality education
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| current pain | Count of Participants | Participants |
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| history of any previous pain | Count of Participants | Participants |
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| Pain beliefs questionnaire | Pain beliefs questions: answer on 11 point Likert Scale from strongly disagree=0 to strongly agree=10
| Mean | Standard Deviation | scores on a scale |
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| revised Neurophysiology of Pain Questionnaire | 12 true/false questions regarding the neurophysiology of pain. Answers of unsure are marked as incorrect answers as individuals are told not to guess at answer and only answer if they think they know the correct answer. Score is the number of correct answers provided. | Mean | Standard Deviation | correct answers |
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| Physical activity Fear Avoidance Beliefs Questionnaire | Questionnaire on fear of physical activity. 7 point Likert scale from completely disagree=0, to completely agree=6
| Mean | Standard Deviation | score on a scale |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes |
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| 20 |
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| Title | Measurements |
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| question 4 |
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| question 5 |
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