FOREVR Peds VR Pilot

Study Overview
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Brief Summary
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To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

Official Title
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Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)

Conditions
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Pain, Postoperative, Pain, Anxiety

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 7to 21 years Able to read, understand, and speak English Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list. Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis Exclusion Criteria: Outside the age range (< 7 or > 21 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 glasses, such as surgeries of the head and neck

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VR - Distraction<br> | Other: VR - Distraction<br>* Participants will be instructed to use any application.<br>|
| Other: VR - Biofeedback<br> | Other: VR - Biofeedback<br>* Participants will be instructed to use the Mindful Aurora application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of VR-distraction on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating 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 numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | Immediately after 10 minute VR session. | 
| Effect of VR-Distraction on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | 15 minutes after 10 minute VR session. | 
| Effect of VR-Distraction on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | 30 minutes after 10 minute VR session. | 
| Effect of VR-Distraction on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | Before 10 minute VR session. | 
| Effect of VR-Distraction on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | Immediately after 10 minute VR session. | 
| Effect of VR-Distraction on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | 15 minutes after 10 minute VR session. | 
| Effect of VR-Distraction on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | 30 minutes after 10 minute VR session. | 
| Effect of VR-Biofeedback on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating 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 using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | Immediately after 10 minute VR session. | 
| Effect of VR-Biofeedback on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | 15 minutes after 10 minute VR session. | 
| Effect of VR-Biofeedback on anxiety | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety | 30 minutes after 10 minute VR session. | 
| Effect of VR-Biofeedback on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | Before 10 minute VR session | 
| Effect of VR-Biofeedback on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | Immediately after 10 minute VR session | 
| Effect of VR-Biofeedback on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | 15 minutes after 10 minute VR session | 
| Effect of VR-Biofeedback on pain | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain | 30 minutes after 10 minute VR session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |