Trial Outcomes & Findings for Virtual Reality Pain Neuroscience Education for Middle School Students (NCT NCT04470375)

Last Updated: 2021-02-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR

Results posted on

2021-02-05

Participant Flow

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.

No exclusion prior to assignment

Participant milestones

Participant milestones
Measure	Middle School VR Students Middle school students viewing the VR on PNE
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality Pain Neuroscience Education for Middle School Students

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Baseline and immediately post intervention, intervention approximately 45 minutes of viewing Pain VR

Outcome measures

Outcome measures
Measure	Middle School VR Students n=20 Participants Middle school students viewing the VR on PNE
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
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
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
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
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

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Middle School VR Students n=20 Participants Middle school students viewing the VR on PNE
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Middle School VR Students n=20 Participants Middle school students viewing the VR on PNE
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
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
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 2.0
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
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

Adverse Events

Middle School VR Students

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kory Zimney

University of South Dakota

Phone: 16056586373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place