Virtual Reality Pain Neuroscience Education for Middle School Students

NCT ID: NCT04470375

Last Updated: 2021-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2020-08-05

Brief Summary

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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

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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

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Pain Education Virtual Reality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group of students receiving Virtual Reality education
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR pain education

Students receiving the 45 minute pain education through Virtual Reality

Group Type EXPERIMENTAL

Virtual Reality Pain Neuroscience Education

Intervention Type BEHAVIORAL

Use of virtual reality media to provide pain neuroscience education

Interventions

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Virtual Reality Pain Neuroscience Education

Use of virtual reality media to provide pain neuroscience education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Dakota

OTHER

Sponsor Role lead

Responsible Party

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Kory Zimney

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kory J Zimney, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

University of South Dakota

Locations

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Evidence in Motion (Lake Forest Country Clug)

Louisville, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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USD-IRB-20-129

Identifier Type: -

Identifier Source: org_study_id

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