Renal ColicNCT07070401
The Use of AR / VR in Patients Presenting to the ED With Renal Colic
A study testing Commercial AR/VR Headset with Calming App in people with Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, run by Community Medical Center, Toms River, NJ at 1 site in United States.
Trial summary
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
- What is being tested?
- Commercial AR/VR Headset with Calming App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
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- Compliance with the virtual reality treatment
- Keeps the headset on for the duration of the experience
- Understands the instructions
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Robert Wood Johnson Barnabas Health Community Medical Center
Toms River, New Jersey, 08755
Greg Neyman, MD, 732.557.3242, GregoryMD.Neyman@rwjbh.org
Chris Delmaestro, DO
About this study
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
Read the 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.
- Being tested
- Commercial AR/VR Headset with Calming App, Pharmacologic Standard of Care Alone
- Keywords
- Renal Colic, Nephrolithiasis, Urolithiasis, Emergency Department, Pain Management, Virtual Reality, Augmented Reality, Audiovisual Stimulation, Patient Anxiety
- Medical subject headings
- Renal Colic, Kidney Calculi, Urolithiasis, Nephrolithiasis, Emergencies, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial AR/VR Headset with Calming AppDevice
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
Pharmacologic Standard of Care AloneOther
Pharmacologic Standard of Care Alone
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Pharmacologic Management | Active comparator | Patients receive standard of care pharmacologic management at the discretion of the treating provider Receives: Other: Pharmacologic Standard of Care Alone |
| AR Adjunct Plus Standard of Care Pharmacologic Management | 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 Receives: Device: Commercial AR/VR Headset with Calming App |
What is being measured
The primary outcome is the main question the study is designed to answer.
60 Minute Pain Level
Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
Measured: 60 minutes
Secondary outcomes (7)
30 Minute Pain Level
Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score
Measured: 30 minutes
30 Minute Heart Rate
Change in Heart Rate 30 minutes after enrollment
Measured: 30 minutes
30 Minute Blood Pressure
Systolic and Diastolic Blood Pressures 30 minutes after enrollment
Measured: 30 minutes
60 Minute Heart Rate
Change in Heart Rate 60 minutes after enrollment
Measured: 60 Minutes
60 Minute Blood Pressure
Systolic and Diastolic Blood Pressures 60 minutes after enrollment
Measured: 60 minutes
Rescue Analgesia Use
Requirement for Rescue Analgesia
Measured: 4 hours
Rescue Intervention
Requirement of Specialty Urologic Procedural Intervention for Pain Management (All Cause)
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial between Standard of Care vs Standard of Care + Adjunct AR Calming
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Medical Center, Toms River, NJ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Neyman, Community Medical Center, Toms River, NJ
- Investigators
- Chris Delmaestro, DO, Principal investigator, Rutgers RWJBH Community Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070401
- Sponsor's protocol ID
- 25-001
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21.
PubMed 36680576Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2.
PubMed 29904806Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
PubMed 31308733Gottlieb M, Long B, Koyfman A. The evaluation and management of urolithiasis in the ED: A review of the literature. Am J Emerg Med. 2018 Apr;36(4):699-706. doi: 10.1016/j.ajem.2018.01.003. Epub 2018 Jan 5.
PubMed 29321112Holdgate A, Pollock T. Systematic review of the relative efficacy of non-steroidal anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ. 2004 Jun 12;328(7453):1401. doi: 10.1136/bmj.38119.581991.55. Epub 2004 Jun 3.
PubMed 15178585Epidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis
Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005.
PubMed 18486720
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of AR / VR in Patients Presenting to the ED With Renal Colic
- ClinicalTrials.gov ID
- NCT07070401
- Acronym / sponsor ID
- 25-001
- Keywords
- Renal Colic, Nephrolithiasis, Urolithiasis, Emergency Department, Pain Management, Virtual Reality, Augmented Reality, Audiovisual Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Community Medical Center, Toms River, NJUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial between Standard of Care vs Standard of Care + Adjunct AR Calming
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Pharmacologic Management | Active comparator | Other: Pharmacologic Standard of Care AlonePatients receive standard of care pharmacologic management at the discretion of the treating provider |
| AR Adjunct Plus Standard of Care Pharmacologic Management | Experimental | Device: Commercial AR/VR Headset with Calming AppPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial AR/VR Headset with Calming AppCommercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care | Device | AR Adjunct Plus Standard of Care Pharmacologic Management |
| Pharmacologic Standard of Care AlonePharmacologic Standard of Care Alone | Other | Standard of Care Pharmacologic Management |
Primary outcome
60 Minute Pain Level
Time frame: 60 minutes
Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
7 secondary outcomes
30 Minute Pain Level
Time frame: 30 minutes
30 Minute Heart Rate
Time frame: 30 minutes
30 Minute Blood Pressure
Time frame: 30 minutes
60 Minute Heart Rate
Time frame: 60 Minutes
60 Minute Blood Pressure
Time frame: 60 minutes
Rescue Analgesia Use
Time frame: 4 hours
Rescue Intervention
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 36680576Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21.
- Background: PubMed 29904806Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2.
- Background: PubMed 31308733Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
- Background: PubMed 29321112Gottlieb M, Long B, Koyfman A. The evaluation and management of urolithiasis in the ED: A review of the literature. Am J Emerg Med. 2018 Apr;36(4):699-706. doi: 10.1016/j.ajem.2018.01.003. Epub 2018 Jan 5.
- Background: PubMed 15178585Holdgate A, Pollock T. Systematic review of the relative efficacy of non-steroidal anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ. 2004 Jun 12;328(7453):1401. doi: 10.1136/bmj.38119.581991.55. Epub 2004 Jun 3.
- BackgroundEpidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis
- Background: PubMed 18486720Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Delmaestro, DO principal investigator
Rutgers RWJBH Community Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial AR/VR Headset with Calming App in people with Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, run by Community Medical Center, Toms River, NJ at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Neyman, MD (732.557.3242, GregoryMD.Neyman@rwjbh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60 Minute Pain Level (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07070401, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.