AR/VR Application for Pain Relief in Renal Colic Patients
Commercial AR/VR Headset with Calming App
+ Pharmacologic Standard of Care Alone
Urogenital Diseases+14
+ Calculi
+ Colic
Treatment Study
Summary
Study start date: April 1, 2025
Actual date on which the first participant was enrolled.This study focuses on patients who visit the emergency department (ED) with symptoms of renal colic, a severe type of pain caused by kidney stones. The aim is to explore whether using a virtual or augmented reality (VR/AR) calming application, in addition to the usual pain medications, can help reduce the discomfort experienced by these patients. Kidney stones can be extremely painful, and finding new ways to alleviate this pain could significantly improve patient care and comfort. Participants in this study are divided into two groups. One group receives the standard pain relief medication typically used for kidney stones. The other group receives the same medication along with a calming VR/AR experience using a headset. The study evaluates whether the additional use of VR/AR technology helps in managing pain more effectively than medication alone. There are no specific risks mentioned, but the potential benefit is a more comfortable experience for patients during their ED visit.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.92 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Rutgers Robert Wood Johnson Barnabas Health Community Medical Center
Toms River, United StatesSee the location