VR Solace for Pain and Anxiety Using Survey and Biodata

Study Overview
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Brief Summary
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The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.

Official Title
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Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: VR Solace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey Diagnosis with chronic pain/anxiety Exclusion Criteria: Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia) No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset Exclusions of patient currently taking beta blockers Unable to communicate/read English for survey items Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solace VR<br>This arm will include software that provides immersive distraction based content for pain reduction. | Device: VR Solace<br>* Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported pain level pre-VR session | Pain level pre-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse). | Baseline | 
| Patient-reported pain level post-VR session | Pain level post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse). | 15 minutes after the VR session (post-study completion) | 
| Patient-reported anxiety level pre-VR session | Anxiety level pre-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from Almost Never to Almost Always. The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). | Baseline | 
| Patient-reported anxiety level post-VR session | Anxiety level post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale for each question, e.g. from Almost Never to Almost Always. The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). | 15 minutes after the VR session (post-study completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average heart rate | Average heart rate will be meaused by the VR headset directly | The first minute of VR Solace use (baseline) | 
| Average heart rate | Average heart rate will be meaused by the VR headset directly | The last minute of VR Solace use | 
| Heart rate variability | Heart rate variability will be caculated using the heart rate of the first and last minute of the VR session | The first minute and the last minute of VR Solace use | 
| Pupil diameter | Pupil diameter will be meaused by the VR headset directly | The first minute of VR Solace use (baseline) | 
| Pupil diameter | Pupil diameter will be meaused by the VR headset directly | The last minute of VR Solace use | 
| Pupil diameter variability | Pupil diameter will be meaused by the VR headset directly | The first minute and the last minute of VR Solace use |