Audio Biofeedback for Pain

(NOICE-Icebath Trial)

TC
MS
Overseen ByManYee Suen, MMedSc
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 aims to explore how audio biofeedback, a technology providing sound-based feedback without visual cues, can help manage pain from cold exposure. Participants will use devices like the NOICE device or Quest 3 to determine if this method can alter pain thresholds. Individuals who are generally healthy, speak English, have intact hearing, and are not on certain medications may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new pain management techniques.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any pain medications, beta blockers, or opioids to participate in this trial.

What prior data suggests that this non-visual immersive technology-based audio biofeedback intervention is safe for pain management?

Research has shown that immersive audio feedback systems, such as those used in virtual reality (VR), can help manage pain by altering pain perception through sound. Studies have generally found VR technology easy to use, with few side effects. For instance, VR has been used to reduce pain during medical procedures and for ongoing pain conditions. The FDA has approved some VR systems as an additional treatment for chronic pain, indicating their safety.

Although specific data on the exact audio feedback system used in this trial is unavailable, similar VR systems have not demonstrated major side effects, suggesting these treatments are generally safe for use.12345

Why are researchers excited about this trial?

Researchers are excited about the audio biofeedback intervention because it offers a new, non-invasive way to manage pain. Unlike traditional pain treatments that often rely on medication, this method uses immersive audio technology to help individuals gain awareness and control over their pain. By harnessing the power of sound, it targets the brain's perception of pain, potentially reducing reliance on drugs and their associated side effects. This innovative approach could open up new possibilities for pain management, making it an intriguing area of study.

What evidence suggests that this audio biofeedback intervention is effective for pain?

Research has shown that immersive audio feedback can alter pain perception. In some medical settings, similar virtual reality (VR) systems have reduced pain and discomfort. One study found that VR significantly reduced pain intensity and anxiety in individuals with long-term pain. Another study demonstrated VR's effectiveness in alleviating pain during and after treatment, particularly for chronic muscle and joint pain. These findings suggest that immersive audio feedback without visuals, as tested in this trial, could help manage pain by altering perception and providing relief. Participants in this trial will engage in different sequences of tasks with and without the non-visual immersive technology-based audio biofeedback to assess its effectiveness.13678

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with good hearing and no medical conditions that could make participation unsafe. It's not for those on heart rhythm drugs, pain meds, or with a history of chronic or acute pain syndromes, nor for individuals currently experiencing hearing loss.

Inclusion Criteria

English-speaking
I am 18 years old or older.
My hearing is normal.
See 1 more

Exclusion Criteria

I am taking medication that affects my heart rate.
I use medication to manage my pain.
I have a history of chronic or acute pain.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform tasks with and without non-visual immersive technology-based audio biofeedback to evaluate its effect on cold pain threshold

1-2 weeks
Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Non-visual immersive technology-based audio biofeedback intervention
Trial Overview The study tests an audio biofeedback intervention using devices like NOICE or Quest 3 to see if it can increase the threshold at which participants feel cold-induced pain. Participants will experience both the intervention and no treatment in different periods.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment2 Interventions
Group II: Group 3Experimental Treatment2 Interventions
Group III: Group 2Experimental Treatment2 Interventions
Group IV: Group 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Stanford Clinical Trial Explores Immersive Audio ...The immersive system uses non-visual feedback to potentially modify pain perception behaviorally. Both groups will be closely monitored for ...
Virtual reality and pain management: current trends and future ...In clinical settings and experimental studies, participants immersed in VR experience reduced levels of pain, general distress/unpleasantness and report a ...
Telehealth virtual reality intervention reduces chronic pain ...In a 5-week crossover trial, we compared VR to matched audio content control in individuals with chronic pain. VR significantly reduced pain intensity, anxiety ...
Self-Administered Skills-Based Virtual Reality Intervention ...The secondary goal was to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, ...
Virtual reality as a treatment for chronic musculoskeletal ...Virtual Reality (VR) applications have demonstrated effectiveness in reducing pain, both during and after interventions, and in chronic conditions such as ...
Efficacy of virtual reality for pain relief in medical proceduresImmersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.
Virtual reality-delivered skills-based therapy for chronic ...The FDA authorized the following indication for use: “RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment ...
Exploring the use of immersive virtual reality in adults with ...The use of immersive virtual reality for chronic primary pain is in early stages with lack of consensus regarding the mechanisms and associated dose.
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