Kidney Stones, Urolithiasis, Hypocitraturia, Renal Colic
Conditions
Keywords
Renal Colic, Nephrolithiasis, Urolithiasis, Emergency Department, Pain Management, Virtual Reality, Augmented Reality, Audiovisual Stimulation, Patient Anxiety
Brief summary
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
Detailed 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.
Interventions
DEVICECommercial AR/VR Headset with Calming App
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
OTHERPharmacologic Standard of Care Alone
Pharmacologic Standard of Care Alone
Sponsors
Community Medical Center, Toms River, NJ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial between Standard of Care vs Standard of Care + Adjunct AR Calming
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 60 Minute Pain Level | 60 minutes | Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Minute Pain Level | 30 minutes | Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score |
| 30 Minute Heart Rate | 30 minutes | Change in Heart Rate 30 minutes after enrollment |
| 30 Minute Blood Pressure | 30 minutes | Systolic and Diastolic Blood Pressures 30 minutes after enrollment |
| 60 Minute Heart Rate | 60 Minutes | Change in Heart Rate 60 minutes after enrollment |
| Rescue Analgesia Use | 4 hours | Requirement for Rescue Analgesia |
| Rescue Intervention | 24 Hours | Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause) |
| 60 Minute Blood Pressure | 60 minutes | Systolic and Diastolic Blood Pressures 60 minutes after enrollment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Anxiety | 60 minutes | Anxiety, as measured on a 10 cm line, with 0 being no anxiety, and 10 being worst anxiety patient has experienced, caused by AR Headset, to be measured in the AR Arm only |
| Subjective AR Experience | 60 minutes | Likert Scale Response on if patient would use AR headset again, in AR arm only: 1 - Would Never Use Again; 2 - Would Consider Using Again; 3 - Neutral; 4 - Would Definitely Use Again if Offered; 5 - Would Ask to Use It Even if Not Offered |
Countries
United States
Contacts
Primary ContactGreg Neyman, MD
Outcome results
None listed