Recruiting

VR/AR Calming

Sponsor:

Community Medical Center, Toms River, NJ

Code:

NCT07070401

Conditions

Renal Colic

Kidney Stones, Urolithiasis, Hypocitraturia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Commercial AR/VR Headset with Calming App

Pharmacologic Standard of Care Alone

Study Details

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

Study ID

NCT07070401

Start date

Apr 1, 2025

Status verified date

Jul, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Pharmacologic Management

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

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

Interventions

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

Primary outcome measure

  • 60 Minute Pain Level [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Greg Neyman, MD

732.557.3242GregoryMD.Neyman@rwjbh.org

Locations

Rutgers Robert Wood Johnson Barnabas Health Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Greg Neyman, MD

732.557.3242GregoryMD.Neyman@rwjbh.org

Principal Investigator:

Chris Delmaestro, DO

More Information

Sponsor

Community Medical Center, Toms River, NJ

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Community Medical Center, Toms River, NJ on 2025-07-17.