Pain
Conditions
Keywords
non-visual immersive technology-based audio biofeedback
Brief summary
This prospective, randomized, 2-period crossover study seeks to evaluate the effect of the non-visual immersive technology-based audio biofeedback intervention, delivered through devices such as NOICE device or Quest 3, on cold pain threshold within participants.
Detailed description
This study addresses the research gap in understanding how non-visual immersive technology-based audio biofeedback intervention impacts pain perception in clinical settings. It is important to explore this because non-visual immersive technology-based audio biofeedback intervention may serve as a non-pharmaceutical, non-visual immersive technology-based audio biofeedback alternative to traditional visual-based distraction methods like virtual reality. The investigators hypothesize that participants using the non-visual immersive technology-based audio biofeedback device will report an increased pain threshold compared to not using the device. This knowledge could improve information on the perception of pain for participant who prefer not to use Virtual Reality (VR) headsets.
Interventions
BEHAVIORALNon-visual immersive technology-based audio biofeedback intervention
Participants receive real-time auditory feedback during cold pain endurance tasks.
BEHAVIORALControl (No non-visual immersive technology-based audio biofeedback)
Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 years and older * English-speaking * Intact hearing * No self-reported or clinically diagnosed acute or chronic medical conditions that may affect safe participation
Exclusion criteria
* Use chronotropic heart medications * Use pain medications * Current hearing loss * Currently taking beta blockers, or opioids or other prescription pain medications * History of chronic pain or acute pain syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Immediately after intervention | Pain sensitivity will be measured by Numerical Rating Pain Scale. Participants will rank pain scores on a sliding scale from 0 = No Pain to 10 = Worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Level | Immediately after intervention | Participants will complete the Visual Analog Scale for Measuring Anxiety (VAS-A) immediately following each group of levels tests, where they will rank anxiety scores on a sliding scale from 0 = No anxiety/fear to 100 = Worst possible anxiety/fear |
| Cold pain endurance | Periprocedural | To evaluate Cold Pain Endurance, total time (in seconds) that the participant's hand remains immersed in ice water will be recorded. Start time is defined as the moment immediately prior to immersion, and stop time as the moment the hand is withdrawn. |
| ISO Ergonomic scale | immediately after intervention | The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) |
| System Usability Scale (SUS) Score | immediately after intervention | The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) |
| Device satisfaction | immediately after intervention | To evaluate the overall impact of device satisfaction of the spatial audio stimulation device, participants will complete the Patient Technology Satisfaction Survey. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = completely. |
Countries
United States
Outcome results
None listed