Spatial Audio Stimulation
Conditions
Keywords
Thermal Sensory Analyzer (TSA-II), Peltier-Based Contact Thermode
Brief summary
The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. This research is not studying the NOICE device specifically and the device is not a medical device.
Detailed description
This study addresses the research gap in understanding how spatial audio impacts pain perception, specifically heat pain, in clinical settings. It is important to explore this because spatial audio may serve as a non-pharmaceutical, immersive alternative to traditional visual-based distraction methods like virtual reality. The investigators hypothesize that participants using the spatial audio simulation device will report an increased heat 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 VR headsets.
Interventions
BEHAVIORALSpatial audio stimulation
Study RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial. Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention.
BEHAVIORALNo spatial audio stimulation
Study RA will affix the thermode to the dorsum of the participant's dominant or non-dominant hand. Participants will undergo heat-pain-inducing thermode exposure. The intervention will be randomized to receive spatial audio stimulation or not for the first HPT trial, then crossed over to the other study condition for the second HPT trial. Participants will be randomized to expose their dominant or non-dominant hand first. Between each levels test, the thermode will be moved to the other hand (ex: VR: DH, NDH, DH; Nothing: NDH, DH, NDH). There will be a 30 second break between each levels test and a five-minute washout period between each intervention.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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 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 * Current hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heat pain threshold | Duration of intervention, approximately 15 minutes | Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 44 degrees C, with higher temperatures indicating a higher heat pain threshold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heat pain sensitivity (HPS) | immediately after intervention | To evaluate heat pain sensitivity(HPS), participants will complete the Numerical Rating Pain Scale (NRPS) immediately following each trial, where they rank pain sensitivity on an ordinal scale from 0 = no pain to 10 = worst pain possible under both treatment conditions. |
| 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 |
| 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