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Recruiting NCT07070401

The Use of AR / VR in Patients Presenting to the ED With Renal Colic

No phase Interventional Renal Colic Kidney Stones, Urolithiasis, Hypocitraturia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Commercial AR/VR Headset with Calming App, Pharmacologic Standard of Care Alone.
Who it may be relevant to
Registry conditions: Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients

Detailed description

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.

Interventions

  • Device Commercial AR/VR Headset with Calming App
    Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
  • Other Pharmacologic Standard of Care Alone
    Pharmacologic Standard of Care Alone

Primary outcome measures

  • 60 Minute Pain Level [Time frame: 60 minutes]
Secondary outcome measures (7)
  • 30 Minute Pain Level [Time frame: 30 minutes]
  • 30 Minute Heart Rate [Time frame: 30 minutes]
  • 30 Minute Blood Pressure [Time frame: 30 minutes]
  • 60 Minute Heart Rate [Time frame: 60 Minutes]
  • 60 Minute Blood Pressure [Time frame: 60 minutes]
  • Rescue Analgesia Use [Time frame: 4 hours]
  • Rescue Intervention [Time frame: 24 Hours]

Eligibility criteria

Inclusion criteria

  • Patient self-reported history of nephrolithiasis
  • 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

  • Age < 18 years
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rutgers Robert Wood Johnson Barnabas Health Community Medical Center — Toms River

Publications

  • 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. PMID 36680576
  • 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. PMID 29904806
  • 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. PMID 31308733
  • 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. PMID 29321112
  • 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. PMID 15178585
  • 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. PMID 18486720

Identifiers

NCT: NCT07070401 · 25-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗