An interventional study of Commercial AR/VR Headset with Calming App and Pharmacologic Standard of Care Alone in Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, sponsored by Community Medical Center, Toms River, NJ. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Community Medical Center, Toms River, NJ · Not applicable, Interventional, and Treatment
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
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.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 92 is below the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →Community Medical Center, Toms River, NJ is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard of care pharmacologic management at the discretion of the treating provider
Other: Pharmacologic Standard of Care Alone
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
Device: Commercial AR/VR Headset with Calming App
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
Pharmacologic Standard of Care Alone
60 Minute Pain Level
Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
Time frame: 60 minutes
30 Minute Pain Level
Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score
Time frame: 30 minutes
30 Minute Heart Rate
Change in Heart Rate 30 minutes after enrollment
Time frame: 30 minutes
30 Minute Blood Pressure
Systolic and Diastolic Blood Pressures 30 minutes after enrollment
Time frame: 30 minutes
60 Minute Heart Rate
Change in Heart Rate 60 minutes after enrollment
Time frame: 60 Minutes
60 Minute Blood Pressure
Systolic and Diastolic Blood Pressures 60 minutes after enrollment
Time frame: 60 minutes
Rescue Analgesia Use
Requirement for Rescue Analgesia
Time frame: 4 hours
Rescue Intervention
Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause)
Time frame: 24 Hours
Visual Analog Scale for Anxiety
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
Time frame: 60 minutes
Subjective AR Experience
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
Time frame: 60 minutes
Plan to share: No
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Community Medical Center, Toms River, NJ