Virtual Reality Distraction for Reduction
Study Details
Study Description
Brief Summary
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: VR googles using exposure sham program The study groups will receive VR googles and the sham program |
Device: Placebo comparator: VR googles and the non reality experience
parallel assignment (this arm will receive a static presentation in the same device)
|
| Active Comparator: VR googles and the real VR program experience. 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
Parallel assignment (this arm will receive the full immersive virtual reality experience
|
Outcome Measures
Primary Outcome Measures
- Pain Scores [From the end of surgery until 48 hours after surgery or discharge, whichever comes first]
The investigators will assess pain using NRS scores (0-10, with 10 being worst)
Secondary Outcome Measures
- Total opioid consumption [Within the first 72 hours.]
the investigators will measure total opioid consumption converted to morphine milligram equivalents (MME).
- Time weighted average pain score [Every 4 hours by standard of care during the first 48 hours after surgery or hospital discharge, whichever comes first using NRS scores (0-10, with 10 being worst).]
The investigators will capture all pain scores measurements
- Perception of video system usability [Once after the last assessment or hospital discharge, whichever comes first.]
Patient's perception of video system usability will be 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.
- Post discharge analgesia. [One week (7days) after hospital discharge]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
American Society of Anesthesiology Physical Status 1-3;
-
Scheduled for elective, primary total hip arthroplasty;
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Anticipated hospitalization of at least 1 night;
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Expected to require parenteral opioids for postoperative pain;
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Able to use IV PCA systems.
Exclusion criteria:
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History of chronic pain or care by a pain management specialist;
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Use of more than 30 mg/day of oral oxycodone (or equivalent);
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Greater than 12 weeks of current and continued opioid use;
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History of seizures, epilepsy, motion sickness, stroke, dementia;
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Non-English speaking;
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Women who are pregnant or breastfeeding;
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History of substance use disorder.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Fairview Hospital | Cleveland | Ohio | United States | 44111 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Sabry Ayad, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-769