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

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

Study Overview

• Status: Recruiting
• Conditions: Renal Colic; Kidney Stones, Urolithiasis, Hypocitraturia
• Intervention / Treatment: Other: Pharmacologic Standard of Care Alone; Device: Commercial AR/VR Headset with Calming App

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greg Neyman, MD; Phone Number: 732.557.3242; Email: GregoryMD.Neyman@rwjbh.org

Study Locations

• United States
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • Rutgers Robert Wood Johnson Barnabas Health Community Medical Center
      • Contact: Greg Neyman, MD; Phone Number: 732.557.3242; Email: GregoryMD.Neyman@rwjbh.org
      • Principal Investigator: Chris Delmaestro, DO
      • Sub-Investigator: Emerson Franke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60 Minute Pain Level	Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score	60 minutes

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Community Medical Center, Toms River, NJ
• Investigators: Principal Investigator: Chris Delmaestro, DO, Rutgers RWJBH Community Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Colorado Department of Public Health and Environment. Pain Scales. Colorado Department of Public Health and Environment, 2024

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Department; Urolithiasis; Virtual Reality; Augmented Reality; Pain Management; Nephrolithiasis; Renal Colic; Patient Anxiety; Audiovisual Stimulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infant, Newborn, Diseases; Nephrolithiasis; Kidney Calculi; Urinary Calculi; Urolithiasis; Colic; Renal Colic
• Other Study ID Numbers: 25-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No