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

Community Medical Center, Toms River, NJ

Status: Enrolling

Conditions: Kidney Stones, Urolithiasis, Hypocitraturia; Renal Colic

Treatments: Device: Commercial AR/VR Headset with Calming App; Other: Pharmacologic Standard of Care Alone

Study type: Interventional

Funder types: Other

Identifiers

NCT07070401

25-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Standard of Care Pharmacologic Management

Active Comparator group

Description:

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

Treatment:

Other: Pharmacologic Standard of Care Alone

AR Adjunct Plus Standard of Care Pharmacologic Management

Experimental group

Description:

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

Treatment:

Device: Commercial AR/VR Headset with Calming App