Virtual Reality (VR) for Prone Pain Procedures

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

Official Title
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Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic

Conditions
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Virtual Reality, Anxiety, Pain

Intervention / Treatment
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* Other: Virtual Reality Headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure English speaking and with the ability to understand oral and written instructions 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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Patients undergo prone pain procedure with virtual reality distraction | Other: Virtual Reality Headset<br>* Patient uses a virtual reality headset and support during prone pain procedure<br>* Other names: Oculus Quest Virtual Reality Headset;|
| No Intervention: Control<br>Patients undergo prone 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 | 
| 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 after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Score | Anxiety 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 | 
| 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 | 
| 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 | 
| Sedation Requirements | Amount of benzodiazepines and opioid medications given | During course of procedure |