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?

This trial tests new methods to reduce pain and anxiety during office-based laryngology procedures, which involve examining or treating the throat. It explores whether augmented reality (AR) games or vibroacoustic stimulation (a type of vibration therapy) can make the experience less stressful by distracting patients from pain. The trial includes different groups: one using AR, one using vibration, one combining both, and one with no additional treatment, to determine which is most effective. It seeks patients with upcoming throat-related procedures in the office setting. As an unphased trial, this study provides patients the opportunity to explore innovative methods that could enhance comfort during procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that augmented reality and vibroacoustic stimulation are safe for reducing pain and anxiety?

Research shows that both vibroacoustic stimulation and augmented reality are generally safe and well-tolerated. Studies on vibroacoustic therapy indicate it can reduce pain and stress without significant side effects. For instance, one study found that using vibroacoustic sound waves to manage pain did not cause any major problems.

Similarly, augmented reality has been studied for treatments like stroke recovery and pain relief. These studies report that augmented reality is generally safe, with no serious negative effects for users.

Combining both treatments appears promising too. Although specific data on their combined safety is limited, both therapies alone have good safety records. This suggests that using them together is likely safe as well. Always consult the study team or a healthcare provider if there are specific concerns about joining a trial.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for acute pain because they use augmented reality and vibroacoustic stimulation, offering a novel approach compared to traditional pain medications like opioids and NSAIDs. Augmented reality provides a visual distraction that can reduce pain perception and anxiety without the side effects typical of drugs. Vibroacoustic stimulation uses sound waves and vibrations to soothe and calm the nervous system, potentially offering a non-invasive alternative to pain management. Together, these techniques could provide fast relief and a safer, drug-free option for managing acute pain, which is why researchers are eager to explore their effectiveness.

What evidence suggests that this trial's treatments could be effective for reducing pain and anxiety during in-office procedures?

Research has shown that vibroacoustic therapy, a treatment in this trial, can reduce pain and anxiety by using sound waves to create calming vibrations in the body. Some studies suggest it lowers stress and eases discomfort, but more research is needed to confirm these effects for various types of pain. Augmented reality (AR), another treatment option in this trial, distracts patients through visual engagement, potentially reducing pain and anxiety during medical procedures. The trial will also explore combining vibroacoustic therapy and AR, which might enhance these benefits. AR provides visual distraction, while vibroacoustic therapy offers physical relaxation. Together, they show promise in improving patient comfort during procedures.12367

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+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36848215/
An Augmented Reality App for the Treatment of Spatial ...This study aimed to develop an AR-based app (Negami) for the treatment of spatial neglect that combines visual exploration training with active, ...
Detection of Stroke-Induced Visual Neglect and Target ...We have developed a BCI system called AR-based EEG-guided neglect detection system called. AREEN to detect SN and potentially neglected visual targets. Early ...
AR-Based EEG-Guided Neglect Detection System for Stroke ...AR-based EEG-guided neglect detection in stroke rehab using HoloLens AR and real-time brain data for accurate, personalized rehabilitation.
Negami: An Augmented Reality App for the Treatment of ...This study aimed to develop an AR-based app (Negami) for the treatment of spatial neglect that combines visual exploration training with active, ...
Detection of Stroke-Induced Visual Neglect and Target ...Previously, we built a system called augmented reality-based EEG-guided neglect detection, assessment, and rehabilitation system (AREEN) with a ...
An Augmented Reality Based System for Neglect Detection ...The aim of this phase is to examine the feasibility and acceptability of the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37582475/
Spatial Neglect Therapy With the Augmented Reality App ...Results: Both groups improved significantly. While the Negami therapy group improved in 4 of 5 neglect tests used, the standard therapy ...
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