Virtual Reality and Pain

Study Overview
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Brief Summary
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Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.

Official Title
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Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials

Conditions
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Pain, Postoperative, Pain, Anxiety Postoperative

Intervention / Treatment
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* Other: VR-Biofeedback
* Other: VR-Distraction
* Other: 360 Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 8 - 18 years Able to read, understand and speak English Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service Exclusion Criteria: Outside the age range (< 8 or > 18 years) History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting) History of vertigo, dizziness, and/or seizure disorder Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VR-Biofeedback<br> | Other: VR-Biofeedback<br>* Participants will be instructed to use the Mindful Aurora application<br>|
| Other: VR-Distraction<br> | Other: VR-Distraction<br>* Participants will be instructed to use one of three applications<br>|
| Other: 360 Video<br> | Other: 360 Video<br>* Participants will be instructed which video to view<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of VR-biofeedback on pain | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Postoperatively 24 - 90 hours. | 
| Effect of VR-distraction on pain | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Postoperatively 24 - 90 hours. | 
| Effect of 360 video on pain | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. | Postoperatively 24 - 90 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of VR-biofeedback on anxiety | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. | Before 10 minute VR session. | 
| Effect of VR-biofeedback on anxiety | Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | After 10 minute VR session. Anxiety will be rated using a visual analog scale. | 
| Effect of VR-biofeedback on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge | 
| Effect of VR-distraction on anxiety | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | Before 10 minute VR session. | 
| Effect of VR-distraction on anxiety | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | After 10 minute VR session. | 
| Effect of VR-distraction on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge | 
| Effect of 360 video on anxiety | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | Before 10 minute VR session. | 
| Effect of 360 video on anxiety | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | After 10 minute VR session. | 
| Effect of 360 video on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge | 
| Role of anxiety on changes in pain | Participants will complete a questionnaire regarding anxiety | One time prior to study visit | 
| Role of pain catastrophizing | Participants will complete a questionnaire regarding pain | One time prior to study visit |