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Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
This study will randomize ED patients presenting for presumed renal colic to either standard pharmacologic pain management alone, or pharmacologic management plus use of an adjunct Virtual / Augmented reality calming application using an off-the-shelf VR/AR Headset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Pharmacologic Management | Active Comparator | Patients receive standard of care pharmacologic management at the discretion of the treating provider |
|
| AR Adjunct Plus Standard of Care Pharmacologic Management | Experimental | Patients receive adjunct AR Calming App via commercial AR/VR headset in addition to standard of care pharmacologic management at the discretion of the treating provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial AR/VR Headset with Calming App | Device | Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 60 Minute Pain Level | Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Minute Pain Level | Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score | 30 minutes |
| 30 Minute Heart Rate | Change in Heart Rate 30 minutes after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Anxiety | Anxiety, as measured on a 10 cm line, with 0 being no anxiety, and 10 being worst anxiety patient has experienced, caused by AR Headset, to be measured in the AR Arm only | 60 minutes |
| Subjective AR Experience |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greg Neyman, MD | Contact | 732.557.3242 | GregoryMD.Neyman@rwjbh.org |
| Name | Affiliation | Role |
|---|---|---|
| Chris Delmaestro, DO | Rutgers RWJBH Community Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Barnabas Health Community Medical Center | Recruiting | Toms River | New Jersey | 08755 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36680576 | Background | Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21. | |
| 29904806 | Background | Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2. |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| D053040 | Nephrolithiasis |
| D004630 | Emergencies |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized Controlled Trial between Standard of Care vs Standard of Care + Adjunct AR Calming
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| Pharmacologic Standard of Care Alone | Other | Pharmacologic Standard of Care Alone |
|
| 30 minutes |
| 30 Minute Blood Pressure | Systolic and Diastolic Blood Pressures 30 minutes after enrollment | 30 minutes |
| 60 Minute Heart Rate | Change in Heart Rate 60 minutes after enrollment | 60 Minutes |
| 60 Minute Blood Pressure | Systolic and Diastolic Blood Pressures 60 minutes after enrollment | 60 minutes |
| Rescue Analgesia Use | Requirement for Rescue Analgesia | 4 hours |
| Rescue Intervention | Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause) | 24 Hours |
Likert Scale Response on if patient would use AR headset again, in AR arm only: 1 - Would Never Use Again; 2 - Would Consider Using Again; 3 - Neutral; 4 - Would Definitely Use Again if Offered; 5 - Would Ask to Use It Even if Not Offered
| 60 minutes |
| 31308733 | Background | Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019. |
| 29321112 | Background | Gottlieb M, Long B, Koyfman A. The evaluation and management of urolithiasis in the ED: A review of the literature. Am J Emerg Med. 2018 Apr;36(4):699-706. doi: 10.1016/j.ajem.2018.01.003. Epub 2018 Jan 5. |
| 15178585 | Background | Holdgate A, Pollock T. Systematic review of the relative efficacy of non-steroidal anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ. 2004 Jun 12;328(7453):1401. doi: 10.1136/bmj.38119.581991.55. Epub 2004 Jun 3. |
| Background | Epidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis |
| 18486720 | Background | Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005. |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |