Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.

Official Title
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Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic

Conditions
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Virtual Reality, Anxiety, Pain

Intervention / Treatment
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* Device: Virtual Reality Headset Distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure English speaking Having the ability to understand oral and written instructions Willing to fill out psychometric surveys. Exclusion Criteria: Pregnant women Prisoners Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

Ages Eligible for Study
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Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Arm<br>Patients undergo interventional pain procedure with virtual reality distraction | Device: Virtual Reality Headset Distraction<br>* Patient wears a virtual reality headset during interventional pain procedure<br>|
| No Intervention: No Intervention Arm<br>Patients undergo interventional pain procedure without virtual reality distraction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Score | State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety) | Immediately before procedure and immediately after procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain) | Immediately before procedure, during procedure, and immediately after procedure | 
| Sedation Requirements | Amount of benzodiazepines and opioid medications given | During course of procedure | 
| Global Impression of Change | Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status) | Immediately after procedure | 
| Patient Experience Satisfaction | Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction) | Immediately after procedure |