PainNCT04470375

Virtual Reality Pain Neuroscience Education for Middle School Students

A study testing Virtual Reality Pain Neuroscience Education in people with Pain and Education, run by University of South Dakota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Education, Virtual Reality
What is being tested?: Virtual Reality Pain Neuroscience Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2020to 5 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Evidence in Motion (Lake Forest Country Clug)
Louisville, Kentucky, 40245

Other trials in United States

About this study

Official title: Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs

Read the 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.

Conditions: Pain, Education, Virtual Reality
Being tested: Virtual Reality Pain Neuroscience Education
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Pain Neuroscience EducationBehavioural
Use of virtual reality media to provide pain neuroscience education

Study groups in NCT04470375
Study group	Role	What they receive
VR pain education	Experimental	Students receiving the 45 minute pain education through Virtual Reality Receives: Behavioral: Virtual Reality Pain Neuroscience Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 20205 Aug 2020

First posted14 Jul 2020
Study start4 Aug 2020
Primary completion5 Aug 2020
Study completion5 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: single group of students receiving Virtual Reality education
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04470375
Sponsor's protocol ID: USD-IRB-20-129
Status last verified: Jan 2021
First submitted: 7 Jul 2020
Last updated: 5 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be stored for required 3 year period after study. No intent at this time to share data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs
ClinicalTrials.gov ID: NCT04470375
Acronym / sponsor ID: USD-IRB-20-129
Conditions: Pain, Education, Virtual Reality
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of South DakotaUniversity, hospital or other
Study start: 4 Aug 2020 (actual)
Primary completion: 5 Aug 2020 (actual)
Study completion: 5 Aug 2020 (actual)
First posted: 14 Jul 2020 (actual)
Results: Posted 22 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: single group of students receiving Virtual Reality education

Arm	Type	Receives
VR pain education	Experimental	Behavioral: Virtual Reality Pain Neuroscience EducationStudents receiving the 45 minute pain education through Virtual Reality

Who may qualify

Ages: 10 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual Reality Pain Neuroscience EducationUse of virtual reality media to provide pain neuroscience education	Behavioural	VR pain education

Primary outcome

Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 22 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Middle School VR Students	20	20

Primary outcome: Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later

Time frame: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR. Mean (Standard Deviation). Unit: score on a scale

Measure	Middle School VR Students n = 20
question 1	.35 (2.6)
question 2	.95 (3.1)
question 3	.45 (2.4)
question 4	.55 (2.7)
question 5	-.1 (2.6)

Middle School VR Students: p = .137, t-test, 2 sided

Primary outcome: Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later

Time frame: Change in baseline score immediately post intervention, approximately 45 minutes after VR intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Middle School VR Students n = 20
Value	1.45 (1.8)

Middle School VR Students: p = .010, t-test, 2 sided

Primary outcome: Change in Baseline Physical Activity Subscale of the Fear Avoidance Belief Questionnaire Scores to Post VR Viewing, Approximately 45 Minutes Later

Time frame: Change in baseline score immediately post intervention of viewing VR, approximately 45 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Middle School VR Students n = 20
question 1	.2 (1.2)
question 2	-.05 (2.3)
question 3	.55 (2.0)
question 4	-1.0 (1.8)
question 5	-.35 (1.9)

Middle School VR Students: p = .591, t-test, 2 sided

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Middle School VR Students	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data will be stored for required 3 year period after study. No intent at this time to share data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kory J Zimney, PT, DPT principal investigator

University of South Dakota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Pain Neuroscience Education in people with Pain and Education, run by University of South Dakota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later (time frame: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.