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

NCT07070401 | Recruiting

• 1 other identifier: 25-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Colic; Kidney Stones, Urolithiasis, Hypocitraturia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 60 Minute Pain Level

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

  60 minutes

Secondary Outcomes (7)

• 30 Minute Pain Level

  30 minutes

• 30 Minute Heart Rate

  30 minutes

• 30 Minute Blood Pressure

  30 minutes

• 60 Minute Heart Rate

  60 Minutes

• 60 Minute Blood Pressure

  60 minutes

Other Outcomes (2)

• Visual Analog Scale for Anxiety

  60 minutes

• Subjective AR Experience

  60 minutes

Study Arms (2)

Standard of Care Pharmacologic Management

ACTIVE COMPARATOR

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

Other: Pharmacologic Standard of Care Alone

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

Device: Commercial AR/VR Headset with Calming App

Interventions

Commercial AR/VR Headset with Calming App DEVICE

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

AR Adjunct Plus Standard of Care Pharmacologic Management

Pharmacologic Standard of Care Alone OTHER

Pharmacologic Standard of Care Alone

Standard of Care Pharmacologic Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Community Medical Center, Toms River, NJ: lead

Study Sites (1)

Rutgers Robert Wood Johnson Barnabas Health Community Medical Center

Toms River, New Jersey, 08755, United States

RECRUITING

Related Publications (7)

• 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 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.

  PMID: 29904806 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.

  PMID: 31308733 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.

  PMID: 29321112 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.

  PMID: 15178585 BACKGROUND

• Epidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis

  BACKGROUND

• Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005.

  PMID: 18486720 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Renal Colic; Kidney Calculi; Urolithiasis; Nephrolithiasis; Emergencies; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Chris Delmaestro, DO

  Rutgers RWJBH Community Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Neyman, MD

CONTACT

732.557.3242; GregoryMD.Neyman@rwjbh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Randomized Controlled Trial between Standard of Care vs Standard of Care + Adjunct AR Calming

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: July 17, 2025
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)