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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Arm | Experimental | Patients undergo interventional pain procedure with virtual reality distraction |
|
| No Intervention Arm | No Intervention | Patients undergo interventional pain procedure without virtual reality distraction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset Distraction | Device | Patient wears a virtual reality headset during interventional pain procedure |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naileshni Singh, MD | University of California, Davis | Principal Investigator |
| John Sun, MD | University of California, Davis | Principal Investigator |
| Michael Jung, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Interventional Pain Clinic | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |