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Vibroacoustic for Laryngeal Cancer (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

PARVA Trial 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.Check my eligibility

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.See study design

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.

PARVA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average pain experienced

Change in average heart rate

Change in heart rate variability during procedure

+4 more

Secondary outcome measures

Change is STAI score

Pain catastrophizing score

Patient satisfaction

PARVA 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

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,993 Total Patients Enrolled

James J Daniero, MDPrincipal InvestigatorUniversity of Virginia

1 Previous Clinical Trials

150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being actively recruited for this ongoing clinical trial?

"Indeed, clinicaltrials.gov indicates that this clinical trial is currently seeking participants. The initial posting of the study was on October 1st, 2022 and it has been updated most recently on January 17th, 2024."

Answered by AI

What is the total number of subjects being examined in this particular research investigation?

"Indeed, the information available on clinicaltrials.gov indicates that patient recruitment for this trial is currently ongoing. The trial was originally posted on October 1st, 2022 and has been recently updated as of January 17th, 2024. The study aims to enroll a total of 80 patients from a single site."

Answered by AI

Recent research and studies

Aesthetic Surgery JournalJournal

Investigating the Efficacy of Vibration Anesthesia to Reduce Pain from Cosmetic Botulinum Toxin Injections

Sharma, Pooja, Craig N. Czyz, and Allan E. Wulc. 2011. “Investigating the Efficacy of Vibration Anesthesia to Reduce Pain from Cosmetic Botulinum Toxin Injections”. Aesthetic Surgery Journal. Oxford University Press (OUP). doi:10.1177/1090820x11422809.

clinicaltrials.govStudy

Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

James Daniero, MD 2022. "Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227039.

All > Acute Pain