Recruiting

AR/VR Application for Pain Relief in Renal Colic Patients

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What is being tested

Commercial AR/VR Headset with Calming App

+ Pharmacologic Standard of Care Alone
Device
Other
Who is being recruted

Renal Colic

+ Kidney Stones, Urolithiasis, Hypocitraturia
Over 18 Years
+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: April 2025

See protocol details

Summary

Principal SponsorCommunity Medical Center, Toms River, NJ
Study ContactGreg Neyman, MD
Last updated: July 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2025Actual 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.

Official TitleThe Use of AR / VR in Patients Presenting to the ED With Renal Colic 
Principal SponsorCommunity Medical Center, Toms River, NJ
Study ContactGreg Neyman, MD
Last updated: July 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
92 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Renal Colic
Kidney Stones, Urolithiasis, Hypocitraturia
Criteria
9 inclusion criteria required to participate
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)

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11 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Patients receive standard of care pharmacologic management at the discretion of the treating provider
Group II
Experimental
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
Study Objectives
Primary Objectives

Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
Secondary Objectives

Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score

Change in Heart Rate 30 minutes after enrollment

Systolic and Diastolic Blood Pressures 30 minutes after enrollment

Change in Heart Rate 60 minutes after enrollment

Systolic and Diastolic Blood Pressures 60 minutes after enrollment

Requirement for Rescue Analgesia

Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause)

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
Recruiting
Rutgers Robert Wood Johnson Barnabas Health Community Medical CenterToms River, United StatesSee the location
Recruiting
One Study Center