Augmented Reality and Vibration for Acute Pain

(PARVA Trial)

Overseen By Elena Miller, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

Trial Summary

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.

Research Team

James J Daniero, MD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Vibroacoustic Experimental Treatment 2 Interventions

This arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off.

Group II: Combination vibroacoustic and augmented reality Experimental Treatment 2 Interventions

This arm will use both the augmented reality game and vibroacoustic device to provide a visual stimulus to the patient as treatment to reduce pain and anxiety.

Group III: Augmented Reality Experimental Treatment 2 Interventions

This arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off.

Group IV: No treatment Active Control 1 Intervention

This arm will be the current standard of care

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+