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Recruiting

NCT Number: NCT07070401

The Use of AR / VR in Patients Presenting to the ED With Renal Colic

Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Robert Wood Johnson Barnabas Health Community Medical Center

Toms River, New Jersey, 08755, United States

Location status: Recruiting

Location contact

Chris Delmaestro, DO

PRINCIPAL_INVESTIGATOR

Emerson Franke, MD

SUB_INVESTIGATOR

Greg Neyman, MD

CONTACT

[email protected]

732.557.3242

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercial AR/VR Headset with Calming App

Device

Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care

Pharmacologic Standard of Care Alone

Other

Pharmacologic Standard of Care Alone

Primary outcomes

  1. 60 Minute Pain Level

    Time frame: 60 minutes

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

Secondary outcomes

  1. 30 Minute Pain Level

    Time frame: 30 minutes

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

  2. 30 Minute Heart Rate

    Time frame: 30 minutes

    Change in Heart Rate 30 minutes after enrollment

  3. 30 Minute Blood Pressure

    Time frame: 30 minutes

    Systolic and Diastolic Blood Pressures 30 minutes after enrollment

  4. 60 Minute Heart Rate

    Time frame: 60 Minutes

    Change in Heart Rate 60 minutes after enrollment

  5. 60 Minute Blood Pressure

    Time frame: 60 minutes

    Systolic and Diastolic Blood Pressures 60 minutes after enrollment

  6. Rescue Analgesia Use

    Time frame: 4 hours

    Requirement for Rescue Analgesia

  7. Rescue Intervention

    Time frame: 24 Hours

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

Other outcomes

  1. Visual Analog Scale for Anxiety

    Time frame: 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

  2. Subjective AR Experience

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Greg Neyman, MD

CONTACT

[email protected]

732.557.3242

Sponsors and collaborators

Lead sponsor

Community Medical Center, Toms River, NJ

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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