← Back to Search

Augmented Reality and Vibration for Acute Pain (PARVA Trial)

N/A

Recruiting

Led By James J Daniero, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured post-treatment (1 hr).

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the use of vibration and augmented reality (AR) as non-medication options to help patients tolerate in-office procedures better. These procedures are a safe and cost-effective alternative to operating

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve non-pharmacologic methods like vibration and augmented reality for reducing anxiety and pain, side effects may be minimal but could include discomfort from the equipment or distraction techniques used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured post-treatment (1 hr).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured post-treatment (1 hr).

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured post-treatment (1 hr). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average pain experienced

Change in average heart rate

Change in heart rate variability during procedure

+4 more

Secondary study objectives

Change is STAI score

Pain catastrophizing score

Patient satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: VibroacousticExperimental Treatment2 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 realityExperimental Treatment2 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 RealityExperimental Treatment2 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 treatmentActive Control1 Intervention

This arm will be the current standard of care

Do I qualify?Apply below to find out