Virtual Reality Distraction for Reduction

Study Overview
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Brief Summary
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Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.

Detailed Description
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Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.

Official Title
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Virtual Reality Distraction for Reduction in Acute Postoperative Pain

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Placebo comparator: VR googles and the non reality experience
* Device: Active Comparator: VR googles and the real VR program to enter act with and experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology Physical Status 1-3; Scheduled for elective, primary total hip arthroplasty; Anticipated hospitalization of at least 1 night; Expected to require parenteral opioids for postoperative pain; Able to use IV PCA systems. Exclusion criteria: History of chronic pain or care by a pain management specialist; Use of more than 30 mg/day of oral oxycodone (or equivalent); Greater than 12 weeks of current and continued opioid use; History of seizures, epilepsy, motion sickness, stroke, dementia; Non-English speaking; Women who are pregnant or breastfeeding; History of substance use disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: VR googles using exposure sham program<br>The study groups will receive VR googles and the sham program | Device: Placebo comparator: VR googles and the non reality experience<br>* parallel assignment (this arm will receive a static presentation in the same device)<br>|
| Active Comparator: VR googles and the real VR program experience.<br>The study group will receive the VR googles and the real VR program experience. | Device: Active Comparator: VR googles and the real VR program to enter act with and experience<br>* Parallel assignment (this arm will receive the full immersive virtual reality experience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores (Numerical Rating Scale) | The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures. | From the end of surgery until 48 hours after surgery or discharge, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | The investigators measured total opioid consumption converted to morphine milligram equivalents (MME). | End of surgery to 72 hours after surgery. | 
| Time Weighted Average Pain Score | Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures. | End of surgery to 48 hours after surgery | 
| Perception of Video System Usability | Patient's perception of video system usability was assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use. | Once between last intervention time and hospital discharge (up to 8 days after end of surgery) | 
| Post Discharge Analgesia. | Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes. | One week (7 days) after hospital discharge |