80 Participants Needed

Augmented Reality and Vibration for Acute Pain

(PARVA Trial)

JJ
EM
Overseen ByElena Miller, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.

Who Is on the Research Team?

JJ

James J Daniero, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for patients undergoing in-office laryngology procedures, such as those for vocal fold polyps or laryngeal cancer. There are no specific exclusion criteria listed, so it appears open to all individuals who require these types of treatments.

Inclusion Criteria

I am having a throat procedure at my local hospital.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo in-office otolaryngology procedures with or without augmented reality and vibroacoustic stimulation to assess anxiety and pain reduction.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and pain perception post-procedure using surveys and physiological measures.

1 hour post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Augmented Reality
  • Vibroacoustic Stimulation
Trial Overview The study is testing the effects of vibroacoustic stimulation and augmented reality on patient anxiety and pain during office-based ear, nose, and throat procedures. It will compare patient-reported outcomes and physiological stress indicators like heart rate variability with and without these interventions.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: VibroacousticExperimental Treatment2 Interventions
Group II: Combination vibroacoustic and augmented realityExperimental Treatment2 Interventions
Group III: Augmented RealityExperimental Treatment2 Interventions
Group IV: No treatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security