The Use of AR / VR in Patients Presenting to the ED With Renal Colic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCommunity Medical Center, Toms River, NJ
About this trial
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Commercial AR/VR Headset with Calming App
DeviceCommercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care
Pharmacologic Standard of Care Alone
Other interventionPharmacologic Standard of Care Alone
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Pharmacologic ManagementActive comparator 1 intervention
Group B: AR Adjunct Plus Standard of Care Pharmacologic ManagementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
60 Minute Pain Level
Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
Time frame
60 minutesSecondary outcomes
1
30 Minute Pain Level
Pain Level 30 minutes after enrollment, utilizing a 0-10 subjective score
Time frame
30 minutes2
30 Minute Heart Rate
Change in Heart Rate 30 minutes after enrollment
Time frame
30 minutes3
30 Minute Blood Pressure
Systolic and Diastolic Blood Pressures 30 minutes after enrollment
Time frame
30 minutes4
60 Minute Heart Rate
Change in Heart Rate 60 minutes after enrollment
Time frame
60 MinutesOther outcomes
1
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 minutes2
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 minutesSponsors and contacts
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Source ClinicalTrials.gov