AR/VR calming for emergency kidney stone pain
The Use of AR / VR in Patients Presenting to the ED With Renal Colic
This will see if using a calming AR/VR headset alongside usual pain medicines helps people in the emergency room who have kidney stone pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Community Medical Center, Toms River, NJ Academic / other |
| Locations | 1 site (Toms River, New Jersey) |
| Trial ID | NCT07070401 on ClinicalTrials.gov |
What this trial studies
Emergency department patients with presumed renal colic will be randomized to receive standard pharmacologic pain management alone or standard care plus a calming AR/VR application delivered through an off-the-shelf headset. The VR/AR intervention is used as an adjunct during the ED visit and patients must be able to tolerate and keep the headset on for the duration of the experience. Key outcomes include changes in patient-reported pain scores and analgesic (including opioid) use during the ED encounter. The trial enrolls adults with a prior history of nephrolithiasis and moderate-to-severe pain, excluding those who are pregnant, under 18, have chronic pain conditions, fever, or severe anxiety/claustrophobia.
Who should consider this trial
Good fit: Adults who present to the ED with presumed kidney stone pain, have a prior history of nephrolithiasis, report moderate-to-severe pain (>5/10), have normal vital signs, and can tolerate and follow headset instructions.
Not a fit: People under 18, pregnant patients, those with chronic pain disorders, fever or unstable vitals, or severe anxiety/claustrophobia who cannot tolerate a headset are unlikely to benefit.
Why it matters
Potential benefit: If successful, the AR/VR adjunct could reduce pain and decrease the need for opioid or additional analgesics during emergency treatment of kidney stones.
How similar studies have performed: Previous studies have shown that VR can reduce acute and procedural pain in various settings, but its specific use for ED renal colic is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toms River, New Jersey
- Rutgers Robert Wood Johnson Barnabas Health Community Medical Center — Toms River, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Chris Delmaestro, DO — Rutgers RWJBH Community Medical Center
- Study coordinator: Greg Neyman, MD
- Email: GregoryMD.Neyman@rwjbh.org
- Phone: 732.557.3242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.