Virtual Reality Pain Neuroscience Education for Middle School Students

• Sponsor: University of South Dakota (Other)
• Overall Status: Completed
• CT.gov ID: NCT04470375
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Days): 1
• Patients Per Site Per Month: 608.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Education; Virtual Reality	Behavioral: Virtual Reality Pain Neuroscience Education	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single group of students receiving Virtual Reality educationsingle group of students receiving Virtual Reality education
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cohort Study of Use of Virtual Reality Pain Neuroscience Education for Middle School Students and Effects on Pain Knowledge and Beliefs
• Actual Study Start Date: Aug 4, 2020
• Actual Primary Completion Date: Aug 5, 2020
• Actual Study Completion Date: Aug 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR pain education Students receiving the 45 minute pain education through Virtual Reality	Behavioral: Virtual Reality Pain Neuroscience Education; Use of virtual reality media to provide pain neuroscience education

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evidence in Motion (Lake Forest Country Clug)	Louisville	Kentucky	United States	40245

Sponsors and Collaborators

• University of South Dakota

Investigators

• Principal Investigator: Kory J Zimney, PT, DPT, University of South Dakota

Study Documents (Full-Text)

• Study Protocol - Jun 25, 2020
• Informed Consent Form - Jun 25, 2020

More Information

Publications

None provided.

• Responsible Party: Kory Zimney, Associate Professor, University of South Dakota
• ClinicalTrials.gov Identifier: NCT04470375
• Other Study ID Numbers: USD-IRB-20-129
• First Posted: Jul 14, 2020
• Last Update Posted: Feb 5, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

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 Detail	No exclusion prior to assignment

Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
Overall Participants	20
Age (Count of Participants)
<=18 years	20 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.45 (1.2)
Sex: Female, Male (Count of Participants)
Female	11 55%
Male	9 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	20 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%
current pain (Count of Participants)
no	19 95%
yes	1 5%
history of any previous pain (Count of Participants)
one week	13 65%
one month	4 20%
more than 3 months	2 10%
Not reported	1 5%
Pain beliefs questionnaire (scores on a scale) [Mean (Standard Deviation) ]
pain beliefs question 1.	5.2 (3.1)
pain beliefs question 2.	4.1 (2.2)
Pain beliefs question 3.	1.95 (2.1)
pain beliefs question 4.	2.9 (3.1)
pain beliefs question 5.	5.7 (2.0)
revised Neurophysiology of Pain Questionnaire (correct answers) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [correct answers]	3.9 (1.6)
Physical activity Fear Avoidance Beliefs Questionnaire (score on a scale) [Mean (Standard Deviation) ]
question 1	4.7 (1.5)
question 2	3.6 (1.7)
question 3	3.6 (1.3)
question 4	5.1 (1.2)
question 5	3.3 (1.6)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Pain Beliefs Questionnaire Score After VR Intervention Approximately 45 Minutes Later
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
Measure Participants	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Middle School VR Students
	Comments
	Type of Statistical Test	Other
	Comments	Paired samples pre-post t-test
Statistical Test of Hypothesis	p-Value	.137
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change in Baseline Revised Neurophysiology of Pain Questionnaire to Post Intervention of VR, Approximately 45 Minutes Later
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
Measure Participants	20
Mean (Standard Deviation) [score on a scale]	1.45 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Middle School VR Students
	Comments
	Type of Statistical Test	Other
	Comments	Paired samples t-test (pre - post measure of group)
Statistical Test of Hypothesis	p-Value	.010
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
Measure Participants	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Middle School VR Students
	Comments
	Type of Statistical Test	Other
	Comments	Paired samples t-test (pre post measure of group)
Statistical Test of Hypothesis	p-Value	.591
	Comments
	Method	t-test, 2 sided
	Comments

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.
Adverse Event Reporting Description	any episode of ill feeling while performing the VR or immediately (15 minutes) after performing VR
Arm/Group Title	Middle School VR Students
Arm/Group Description	Middle school students viewing the VR on PNE
All Cause Mortality
	Middle School VR Students
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Middle School VR Students
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Middle School VR Students
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.