The Use of AR / VR in Patients Presenting to the ED With Renal Colic
Recruiting · NCT07070401 · Interventional (participants receive a specific treatment) · Lead sponsor: Community Medical Center, Toms River, NJ
View the official record on ClinicalTrials.gov →Interventions studied
Commercial AR/VR Headset with Calming AppPharmacologic Standard of Care Alone
What this trial is about
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Rutgers Robert Wood Johnson Barnabas Health Community Medical Center - Toms River, New Jersey, United States