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RecruitingNCT07070401Updated Jul 17, 2025

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

An interventional study of Commercial AR/VR Headset with Calming App and Pharmacologic Standard of Care Alone in Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, sponsored by Community Medical Center, Toms River, NJ. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Community Medical Center, Toms River, NJ · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Renal Colic
  • Kidney Stones, Urolithiasis, Hypocitraturia

Keywords

  • Renal Colic
  • Nephrolithiasis
  • Urolithiasis
  • Emergency Department
  • Pain Management
  • Virtual Reality
  • Augmented Reality
  • Audiovisual Stimulation
  • Patient Anxiety
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Active comparator
    Standard of Care Pharmacologic Management

    Patients receive standard of care pharmacologic management at the discretion of the treating provider

    Other: Pharmacologic Standard of Care Alone

  • Experimental
    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

    Device: Commercial AR/VR Headset with Calming App

Interventions

  • DeviceCommercial AR/VR Headset with Calming App

    Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care

  • OtherPharmacologic Standard of Care Alone

    Pharmacologic Standard of Care Alone

05

What researchers measure

Primary outcomes

  1. 60 Minute Pain Level

    Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score

    Time frame: 60 minutes

Secondary outcomes

  1. 30 Minute Pain Level

    Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score

    Time frame: 30 minutes

  2. 30 Minute Heart Rate

    Change in Heart Rate 30 minutes after enrollment

    Time frame: 30 minutes

  3. 30 Minute Blood Pressure

    Systolic and Diastolic Blood Pressures 30 minutes after enrollment

    Time frame: 30 minutes

  4. 60 Minute Heart Rate

    Change in Heart Rate 60 minutes after enrollment

    Time frame: 60 Minutes

  5. 60 Minute Blood Pressure

    Systolic and Diastolic Blood Pressures 60 minutes after enrollment

    Time frame: 60 minutes

  6. Rescue Analgesia Use

    Requirement for Rescue Analgesia

    Time frame: 4 hours

  7. Rescue Intervention

    Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause)

    Time frame: 24 Hours

Other outcomes

  1. 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

    Time frame: 60 minutes

  2. Subjective AR Experience

    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

    Time frame: 60 minutes

06

Study locations

1 of 1 sites recruiting
  • Rutgers Robert Wood Johnson Barnabas Health Community Medical Center
    Toms River, New Jersey 08755, United States
    • Greg Neyman, MD · Contact · GregoryMD.Neyman@rwjbh.org · 732.557.3242
    • Chris Delmaestro, DO · Principal investigator
    • Emerson Franke, MD · Sub investigator
    Recruiting
07

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 18486720 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07070401
Lead sponsor
Community Medical Center, Toms River, NJ
Responsible party
Greg Neyman (Research Director, Community Medical Center, Toms River, NJ) — Principal investigator
First posted
Jul 17, 2025
Start date
Apr 1, 2025
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Jul 17, 2025

Study contacts

Greg Neyman, MD
Contact
GregoryMD.Neyman@rwjbh.org
732.557.3242
Chris Delmaestro, DO
principal investigator · Rutgers RWJBH Community Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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