Education, Pain, Virtual Reality
Conditions
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.
Interventions
BEHAVIORALVirtual Reality Pain Neuroscience Education
Use of virtual reality media to provide pain neuroscience education
Sponsors
University of South Dakota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group of students receiving Virtual Reality education
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR | 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 |
| Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later | Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention | 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 Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No exclusion prior to assignment
Participants by arm
| Arm | Count |
|---|---|
| Middle School VR Students Middle school students viewing the VR on PNE | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Middle School VR Students |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 12.45 years STANDARD_DEVIATION 1.2 |
| current pain no | 19 Participants |
| current pain yes | 1 Participants |
| history of any previous pain more than 3 months | 2 Participants |
| history of any previous pain Not reported | 1 Participants |
| history of any previous pain one month | 4 Participants |
| history of any previous pain one week | 13 Participants |
| Pain beliefs questionnaire pain beliefs question 1. | 5.2 scores on a scale STANDARD_DEVIATION 3.1 |
| Pain beliefs questionnaire pain beliefs question 2. | 4.1 scores on a scale STANDARD_DEVIATION 2.2 |
| Pain beliefs questionnaire Pain beliefs question 3. | 1.95 scores on a scale STANDARD_DEVIATION 2.1 |
| Pain beliefs questionnaire pain beliefs question 4. | 2.9 scores on a scale STANDARD_DEVIATION 3.1 |
| Pain beliefs questionnaire pain beliefs question 5. | 5.7 scores on a scale STANDARD_DEVIATION 2 |
| Physical activity Fear Avoidance Beliefs Questionnaire question 1 | 4.7 score on a scale STANDARD_DEVIATION 1.5 |
| Physical activity Fear Avoidance Beliefs Questionnaire question 2 | 3.6 score on a scale STANDARD_DEVIATION 1.7 |
| Physical activity Fear Avoidance Beliefs Questionnaire question 3 | 3.6 score on a scale STANDARD_DEVIATION 1.3 |
| Physical activity Fear Avoidance Beliefs Questionnaire question 4 | 5.1 score on a scale STANDARD_DEVIATION 1.2 |
| Physical activity Fear Avoidance Beliefs Questionnaire question 5 | 3.3 score on a scale STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| revised Neurophysiology of Pain Questionnaire | 3.9 correct answers STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Time frame: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Middle School VR Students | Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | question 1 | .35 score on a scale | Standard Deviation 2.6 |
| Middle School VR Students | Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | question 2 | .95 score on a scale | Standard Deviation 3.1 |
| Middle School VR Students | Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | question 3 | .45 score on a scale | Standard Deviation 2.4 |
| Middle School VR Students | Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | question 4 | .55 score on a scale | Standard Deviation 2.7 |
| Middle School VR Students | Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later | question 5 | -.1 score on a scale | Standard Deviation 2.6 |
p-value: 0.137t-test, 2 sided
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.
Time frame: Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Middle School VR Students | Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | question 1 | .2 score on a scale | Standard Deviation 1.2 |
| Middle School VR Students | Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | question 2 | -.05 score on a scale | Standard Deviation 2.3 |
| Middle School VR Students | Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | question 3 | .55 score on a scale | Standard Deviation 2 |
| Middle School VR Students | Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | question 4 | -1.0 score on a scale | Standard Deviation 1.8 |
| Middle School VR Students | Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later | question 5 | -.35 score on a scale | Standard Deviation 1.9 |
p-value: 0.591t-test, 2 sided
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
Time frame: Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Middle School VR Students | Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later | 1.45 score on a scale | Standard Deviation 1.8 |
p-value: 0.01t-test, 2 sided