Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs
Phase: NA
Conditions: Pain, Education, Virtual Reality
Sponsor: University of South Dakota

 
 
IRB #: IRB-20-129 
Title: VR PNE for middle school students 
Creation Date: 6-5-2020 
End Date: 6-25-2021 
Status: Approved 
Principal Investigator: Kory Zimney 
Review Board: USD Institutional Review Board 
Sponsor: 
 
 
Study History 
Submission Type  Initial 
Review Type  Expedited 
Decision Approved 
Submission Type  Closure 
Review Type  Unassigned 
Decision 
 
 
 
Key Study Contacts 
Member Kory Zimney 
Role Principal Investigator 
Contact kory.zimney@usd.edu 
Member Kory Zimney 
Role Primary Contact 
Contact kory.zimney@usd.edu 
Member Adriaan Louw 
Role Co-Principal Investigator 
Contact adriaan@eimpt.com 
Date: 6-25-2020 

Welcome 
Initial Submission 
 
 
 
 
Please complete the application with as much detail as possible. If you need assistance, feel 
free to contact the office at 605-677-6184 or humansubjects@usd.edu, or contact us directly 
using the information provided below. 
 
Linda Rupp, IRB Coordinator, 605-658-3743 or Linda.Rupp@usd.edu 
Jackie Stelling, IRB Reviewer, 605-658-3763 or Jackie.Stelling@usd.edu 
Ann Waterbury, Director, 605-658-3767 or Ann.Waterbury@usd.edu 
 
 
 
 
 
Helpful Links: 
 
Application resources and guidelines 
USD Consent form templates 
     Other study forms, as applicable 
VA- specific forms 
 
 
 
 
 
Researcher Training 
 
If you haven't yet completed GCP or CITI training, please do so. We accept the following 
CITI courses: 
 
GRP 2 Social Behavioral Research for Investigators and Key Personnel, Basic Course. 
GRP 1 Biomedical Research Investigators and Key Personnel, Basic Course 

VA- Human Subjects Protection and Good Clinical Practices. 
 
Note: If your CITI profile is affiliated with USD and includes your USD email as your 
perferred email, Cayuse will automatically link your profile with all completed CITI 
modules. 
 

 
 
Are you unsure if this project requires IRB review? 
 
 
Yes- I need the IRB to determine. 
✓ No- My study needs IRB Approval. 
Determination 

 
 
Please select the Principal Investigator. 
 
1. 
Name: Kory Zimney 
Organization: Physical Therapy 
Address: 414 E Clark Street SCSC A384, Vermillion, SD 57069-2390 
Phone: 605-658-6373 
Email: kory.zimney@usd.edu 
 
 
 
 
Please select the Primary Contact. 
(This person will be the main point of contact for the IRB reviewers. VA researchers, 
please add your R&D Officer) 
2. 
Name: Kory Zimney 
Organization: Physical Therapy 
Address: 414 E Clark Street SCSC A384, Vermillion, SD 57069-2390 
Phone: 605-658-6373 
Email: kory.zimney@usd.edu 
 
 
 
Please select the Co-Investigators. 
 
3. 
Name: Adriaan Louw 
Organization: External IRB Study 
Address: 
Phone: 
, Vermillion, SD 57069-2390 
Email: adriaan@eimpt.com 
 
 
 
4. 
Please select the Student Investigators. 
 
Personnel 

 
Please attach all CITI certificates not taken through USD affiliation. 
5. 
CITI_Louw_2024.pdf 
 
 
 
 
 
Describe the Principal Investigator's qualifications to perform or oversee the research. 
 
6. 
Dr. Zimney is an Associate Professor on faculty in the University of South Dakota, Department of 
Physical Therapy actively involved with scholarly work as part of his workload. He is a candidate in 
the PhD program from Nova Southeastern University. He has been involved in multiple 
peer-reviewed publications from methodology, data analysis, and dissemination. 
 
 
 
 
If any of the research team members have relevant training, education, or experience 
that may be valuable to the conduct of this study, please describe here. 
7. 
Dr. Louw has been involved in multiple research studies in the area of Pain Neuroscience Education 
(PNE) some of these have been done with middle school students in the past. He has been involved 
in the development of the virtual reality PNE educational tool to be studied. 
 
 
 
 
8. 
Are you a VA Researcher? 
 
 
Yes 
 
✓ No 

9. 
Do you or any of the investigators have a potential conflict of interest associated with 
this study? 
 
 
Yes 
✓ No 

 
 
1. 
Is this study externally funded? 
 
 
Yes 
✓ No 
 
 
2. 
Have you, or do you plan to, submit this study to another IRB? 
 
 
Yes 
✓ No 
 
 
3. 
Is this project for a student thesis or dissertation? 
 
 
Yes 
✓ No 
 
 
4. 
Are you attaching letters of approval from any schools or businesses involved? 
 
 
Yes 
No 
✓ N/A 
Study Details 

What is the purpose of your research? 
 
5. 
Investigating the use of a Virtual Reality (VR) pain neuroscience education (PNE) platform with 
middle school students. We 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. 

 
 
Check ALL procedures included in your study: 
1.    
 
 
 
 
 
Survey 
Interview or focus group 
✓ Other non-medical procedures 
Analysis of biospecimens, existing data, documents, or records 
Medical intervention 
Study Type 

 
 
From the initial contact of participants through the last contact with participants, please 
describe the study procedures. 
 
 
How will you contact them? What will they do as a part of the study? 
Potential middle school students will be contacted through fliers to local parents in the Louisville, KY 
area via various sports team events. We 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. 
 
1. 
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. 
 
 
 
 
List all surveys, interviews, tests, and interventions from initial screening to closeout, 
that participants will undergo in the research. 
 
2. 
Questionnaire for pre and post VR experience provided in attachment. Questions regarding favorite 
color, favorite TV show and hair color will be used only to match pre and post surveys. 
COVID-19 screening form used to ensure safety of participants and research team. 
 
Attach all surveys, interview questions, tests, ect. here. 
 
COVID_screening form.docx 
Procedures 

School_Post_PNE_VR.docx 
School_Pre_PNE_VR.docx 
 
 
 
Where will the research take place? 
3.    
 
Large reception room at Lake Forest Country Club; 14000 Landmark Drive, Louisville, KY 40245. 
 
 
 
 
Have you notified all areas (personnel and facilities) that need to be prepared to assist 
4. 
you in your research? 
 
 
No 
Yes 
✓ N/A 
 
 
 
Describe how the subjects' privacy will be protected (i.e. testing or interviewing in 
private). 
 
Privacy is about the person, not the data. 
Student participants will complete pre and post test questionnaires at individual station in reception 
room. We will have only 4 spaces of individuals going through VR experience at any one time to 
allow for enough physical distance (> 6 feet). All forms will be filled out on paper so participant does 
not have to verbalize responses. 
 
Staggered times to minimize the number of participants (max of 4) at anytime in the meeting room. 
5. 

Will you be offering compensation or extra credit for participants? 
6. 
 
Yes 
✓ No 
 
 
 
Is it possible that medical or psychological services may be needed from participating in 
7. 
this research? 
 
 
Yes 
✓ No 
 
 
 
Describe how you will ensure that all study personnel are adequately informed about 
8. 
the protocol and their research-related duties? 
Dr. Louw and Dr. Zimney have meet and will continue to meet to ensure that research protocol is 
carried out properly. 
 
 
 
 
Will you be using an investigational drug or device? 
9. 
 
Yes 
✓ No 

 
 
What is the maximum number of participants you plan to enroll? 
 
1. 
You may estimate, however, your enrollment or data collection and analysis cannot 
exceed this number. 
32 
 
 
 
 
Please describe the study population. 
2. 
 
 
Check all that apply. 
✓ Males 
✓ Females 
University Students 
✓ Students in Grades K-12 
Non-English Speaking 
 
 
 
Are you specifically targeting an ethnic group? 
3. 
 
 
Check all that apply. 
American Indian 
African American 
Caucasian 
Alaskan Native 
Participants 

Asian 
Pacific Islander 
Hispanic 
Other 
 
 
 
 
What are the age ranges of the subjects to be enrolled? 
4. 
 
 
Check all that apply. 
Birth-3 
Preschool 3-5 
Elementary 5-10 
✓ Middle School 10-13 
✓ High School 14-17 
Adult 18-64 
Senior Citizens 64 and up 
 
 
 
 
Select any of the vulnerable populations listed below that will be be enrolled in the 
5. 
study. 
 
Check all that apply. 
 
✓ 
Children 
Native American 
Pregnant Women 

Prisoners 
Individuals with diminished mental/physical capacity 
Economically/educationally disadvantaged persons 
Your Students 
Your Employees 
Sexuality: Lesbian/Gay/Bisexual/Other Sexual Identities 
Gender: Transgender 
 
 
 
Please state any inclusionary and exclusionary criteria and how you will screen for this 
criteria. 
 
6. 
Inclusion: willing to view VR educational session, in grades 5, 6, 7, or 8. 
Exclusion: 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. 
 
 
 
 
 
How do you have access to the study population? 
7. 
Dr. Louw knows people in the Louisville, KY area. We have provided the PNE education to some of 
the schools in the area in past and others have expressed interest in getting the education. 
 
 
 
 
8. 
Will the participants be your students or employees? 
 
 
Yes 

✓ No 

 
 
How will you contact and select participants? 
1. 
(i.e. email, flyer, social media) 
We will create a flyer to post at athletic team meeting places. 
 
 
 
 
2. 
How will you obtain consent? 
 
 
Online 
In the content of the email 
Mailed to the subject 
✓ Verbal/Handout (in person) 
Please describe what will be said to the participant to introduce the research, or 
you may attach a script. 
 
Participants and parent/guardian will be provided informed consent form and given 
instructions to read the consent form and to ask any questions that they may have. 
Attach script here. 
 
 
 
 
Verbal (over the phone) 
 
 
 
3. 
Are you collecting signatures on the consent form? 
 
Recruitment and Consent 

✓ Yes, hand-written. 
Yes, electronic signature. 
 
No, my survey doesn't ask for any identifying information and I wish to keep participation 
anonymous. 
 
 
 
Are there any reasons you may need to withdraw a subject from participating? 
4. 
 
 
(not attending appointments, getting injured, etc.) 
✓ Yes 
Please explain: 
 
If they start to experience any adverse response to the VR environment. If they start to 
experience any symptoms (severe dizziness, seizures, eye or muscle twitching or blackouts) 
the VR educational session will be stopped and suggested they follow up with family 
physician. 
 
No 
 
 
 
Are there any consequences for participants who voluntary withdraw early from the 
5. 
study? 
 
(such as return of study devices, return to routine care, etc.) 
 
Yes 
✓ No 
 
 
6. 
Will you be recruiting and enrolling non-English speaking subjects? 
 

Yes 
✓ No 
 
Attach ALL recruitment materials and consent forms. 
Consent Form Templates can be found here. 
7. 
Recruitment flier.docx 
ConsentStatement_VR_PNE.docx 
InformedConsentAssentForChild_VR_PNEl.doc 

 
 
What direct or societal benefits do you expect the subjects to receive from this study? 
1. 
If there is no direct benefit to the subjects, simply state that. 
No direct benefit to participants beyond the educational material provided. 
 
 
 
 
Are there any of the following risks associated with the research? 
2. 
 
 
Check ALL that apply: 
Economic Risk 
Psychological Risk 
✓ Physical Risk 
Legal Risk 
Social Risk 
Collection or use of audio or video recordings. 
Use of private records, including educational records or medical charts. 
 
Collection of information that would be reportable to authorities or collection of information that 
might render the subject prosecutable under the law. (e.g. child abuse, use of illegal substances, 
danger to self or others.) 
 
 
 
Describe the nature of each risk and how you've attempted to minimize it. 
 
 
3. 
Physical risk as a small percent of the normal population can react to flashes of light as occur in 
virtual reality or watching TV. They may experience severe dizziness, seizures, eye or muscle 
twitching or blackouts. The participants will be told to remove the VR headset if they experience an 
Risks and Benefits 

adverse or abnormal responses while viewing the content. Researchers will also be observing the 
participant to see if they present with any adverse response to the VR. 
 
 
 
 
4. 
Are you collecting any of the following information? 
 
 
Depression 
Suicide ideation or thoughts of self-harm 
Thoughts of harming others 
Traumatic events or experiences 
Abuse of any sort (to children, elderly, or spouses, and either emotional or physical) 
Illegal activity (alcohol use for those under 21, drug use, criminal acts) 
Sexual misconduct (as either victim or perpetrator, and may include dating violence, stalking, 
assault, or harassment) 

 
 
Are you collecting an identifier or a link to identify subjects? 
 
1. 
This could be a name, code, or reference number that might be used to identify the 
subject outside the context of the research setting. The key question is, "Is there any 
way that anyone, including the investigator, could start with a data record and trace it 
back to the person being studies?" If yes, then there is an identifier linked to the subject. 
 
✓ Yes 
 
1a. 
 
 
 
 
 
1b. 
 
Explain the link and justify its use. 
 
Each pre and post questionnaire will have the same number on the form to link forms. 
We do ask general questions about favorite color, favorite TV show, and hair color to 
match surveys in case the number on the survey gets removed. There will be no names 
attached to the survey, but the other identifiers could provide a small link to the 
individual. 
 
Who will have access to the identifiers and who will keep the link? 
 
 
 
Only the researchers will have access to the pre and post questionnaires and the 
identifying information will not be transposed to the excel spread sheet that will eventual 
house the information provided in the questionnaires once they are matched up pre and 
post VR session. 
 
 
1c. 
 
 
 
 
1d. 
How will you limit access to the subjects identifiers? 
 
pre and post questionnaires will be destroyed once information is recorded in Excel file 
that will be kept on researchers power-on password protected computer. 
 
How and when will the data be de-identified? 
 
It will be de-identified when data entered into computer Excel file. 
 
No 
Privacy & Confidentiality 

Describe the security plan for your data, including where it will be stored and for how 
long. 
2.    
 
 
You may NOT keep identifiable data indefinitely. 
Data will be saved for 3 years on a power-on password protected computer. 
 
 
 
 
Per federal law and USD IRB policy, do you agree to keep a copy of the de-identified 
3. 
data for three years (six years for VA) 
 
 
✓ I agree 
I do not agree 

 
 
Will you be ACCESSING Protected Health Information (PHI) for screening and 
1. 
recruitment purposes? 
 
 
Yes 
✓ No 
 
 
 
Will you be COLLECTING Protected Health Information (PHI)? 
2. 
 
Yes 
✓ No 
HIPAA 

Project Closure Form 
Closure Submission 
 
 
 
 
1. 
Please check the reason for closing the project: 
 
 
✓ Project complete 
Enrollment closed; research activities limited to analysis of data or biospecimens only. 
Investogator is moving to another institution. 
Project not conducted or canceled. 
 
 
 
2. 
How many total subjects were enrolled ( or data points/biospecimens analyzed)? 
  
20 
 
 
 
 
 
How many total subjects did the IRB approve to be enrolled (or data 
3. 
points/biospecimens analyzed)? 
 
32 
 
If more subjects were enrolled than what was approved, please explain how this 
happened and why an amendment was not submitted: 
 
n/a 

4. 
Are the data de-identified? 
 
 
✓ Yes 
No 
 
 
5. 
Does a code key linked with the identifiers still exist? 
 
 
Yes 
✓ No 
 
 
6. 
Have all recordings been transcribed without identifying information and destroyed? 
 
 
Yes 
No 
✓ N/A 
 
 
 
Describe how and where you will store your data and/or biospecimens? 
7. 
Data stored on PI's power-on password protected computer. 
 
 
 
 
What will be done with the data and/or biospecimens from this study after it is closed? 
8. 

Check ALL that apply. 
 
✓ Possibly used in future research. 
Will not be used in future research. 
Copies of data or biospecimens will be taken with PI to new institution. 
 
 
 
Briefly describe your study and, if applicable, your findings and a final summary: 
 
20 participants viewed the PNE VR session. No adverse events were reported during or after 
viewing the 45 minute VR session. A few small positive shifts in pain beliefs occurred after viewing 
the VR session, but none rose to level of significance. Also there was a reduction in fear related to 
pain, but only one question within the FABQ PA rose to significance. There was a significant shift in 
pain knowledge post viewing the PNE VR session. 
 
 
 
 
If applicable, please attach your final report. 
 
PNE Virtual Reality Middle School.pdf 
 
 
 
 
 
Reminder: The Principal Investigator is required by federal law to maintain all study records, 
including consent forms and a copy of the de-identified data. 
 
 
After study closure, research records must be kept for 3 years (5 years if VA research 
and 6 years if HIPAA protected), regardless of why the study was closed. 
Studies that involve FDA-approvals must maintain records for 2 years after the FDA 
has taken final action on the marketing application. 
All records of human subject research are subject to inspection by federal authorities 
and the IRB. 
9. 

✓ I agree 
 
 

 
 
 
Date: June 25, 2020 
 
The University of South Dakota 
414 E. Clark Street 
Vermillion, SD 57069 
 
PI: Kory Zimney Adriaan Louw 
Re: Initial - IRB-20-129, VR PNE for middle school students 
 
The University of South Dakota Institutional Review Board has rendered the decision below for this study. The 
approval is effective starting June 25, 2020 and will expire on June 25, 2021. 
 
Decision: Approved 
Category: Expedited 7. Research on individual or group characteristics or behavior (including, but not limited to, 
research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and 
social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human 
factors evaluation, or quality assurance methodologies. 
 
Associated Documents: Date-Stamped Advertisement, Date-Stamped Parental Consent, Date-Stamped Assent, 
Screening Form, Questionnaires 
 
Dear Kory Zimney, 
 
The study submission for the proposal referenced above has been reviewed and approved via the procedures of the 
University of South Dakota Institutional Review Board. 
 
Attached in your file is the original consent document that has been stamped with IRB approval and expiration date. 
You must keep this original on file. Please use the original document to make copies for subject enrollment. No 
other consent form should be used. It must be signed by each subject prior to initiation of any protocol procedures. 
In addition, each subject must be given a copy of the signed consent form. 
 
Prior to initiation, promptly report to the IRB, any proposed updates/amendments (e.g., protocol 
amendments/revised informed consents) in previously approved human subjects research activities. 
 
Any research-related injuries (physical or psychological), adverse side effects, or other unexpected problems 
encountered during the conduct of this research study needs to be reported to the IRB within 5 days of notification of 
the occurrence. 

Any modifications to the approved study must be submitted for review through Cayuse IRB. All approval letters and 
study documents are located within the study details in Cayuse IRB. 
 
You have approval for this project through June 25, 2021. When this study is completed please submit a closure form 
through Cayuse. If the study is to last longer than one year, a continuation form needs to be submitted through 
Cayuse at least 14 days prior to the expiration of this study. 
 
If you have any questions, please contact: humansubjects@usd.edu or (605) 658-3743. Sincerely, 
The University of South Dakota Institutional Review Board 
 
Ann Waterbury. M.B.A 
Director, Office of Human Subjects University 
of South Dakota 
(605) 658-3767