The Use of AR / VR in Patients Presenting to the ED With Renal Colic
NCT ID: NCT07070401
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2025-04-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care Pharmacologic Management
Patients receive standard of care pharmacologic management at the discretion of the treating provider
Pharmacologic Standard of Care Alone
Pharmacologic Standard of Care Alone
AR Adjunct Plus Standard of Care Pharmacologic Management
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
Commercial AR/VR Headset with Calming App
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
Interventions
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Commercial AR/VR Headset with Calming App
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
Pharmacologic Standard of Care Alone
Pharmacologic Standard of Care Alone
Eligibility Criteria
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Inclusion Criteria
* Subjective history suggesting that current presentation is similar to past presentations of nephrolithiasis (character, quality, location, intensity of pain; previous surgical intervention or lithotripsy)
* Patients with self-reported moderate to severe pain on the visual pain scale determined as greater than 5/10
* Normal vital signs (afebrile)
* Agreeable to informed consent as dictated by IRB and local practice
* No contraindications to standard therapy (ie fluids, NSAIDs, opioids, etc.)
* Compliance with the virtual reality treatment
* Keeps the headset on for the duration of the experience
* Understands the instructions
Exclusion Criteria
* Pregnant
* Individuals with chronic pain conditions such as fibromyalgia (chronic pain may confound results, as patients may have higher than baseline pain levels affecting their response to medications)
* Individuals with severe anxiety or claustrophobia
* Individuals with severe motion sickness or previous episodes of motion sickness due to VR (those who may not react well to the VR experience)
* Individuals with GFR\<60 or previous documented diagnosis of CKD as they may not be suitable candidate for traditional analgesia
* Individuals with previous opioid dependence
* Requirement of immediate surgery (obstructing calculi with concomitant urinary tract infection)
* Patients with diagnoses meeting admission criteria (sepsis, MI)
* Audio/visual impairment (unable to appreciate stimuli provided by the headset)
* Patients administered opiates as the first line pain control medication will not be included in final data collection, as opioid administration may result in difficulty consenting and understanding the study protocol / design
18 Years
ALL
No
Sponsors
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Community Medical Center, Toms River, NJ
OTHER
Responsible Party
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Greg Neyman
Research Director
Principal Investigators
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Chris Delmaestro, DO
Role: PRINCIPAL_INVESTIGATOR
Rutgers RWJBH Community Medical Center
Locations
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Rutgers Robert Wood Johnson Barnabas Health Community Medical Center
Toms River, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Epidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis
Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005.
Related Links
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Colorado Department of Public Health and Environment. Pain Scales. Colorado Department of Public Health and Environment, 2024
Other Identifiers
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25-001
Identifier Type: -
Identifier Source: org_study_id
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