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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants first perform the task with non-visual immersive technology-based audio biofeedback using the dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the non-dominant hand. |
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| Group 2 | Experimental | Participants first perform the task with non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the dominant hand. |
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| Group 3 | Experimental | Participants first perform the task without non-visual immersive technology-based audio biofeedback using the dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the non-dominant hand. |
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| Group 4 | Experimental | Participants first perform the task without non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the dominant hand. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-visual immersive technology-based audio biofeedback intervention | Behavioral | Participants receive real-time auditory feedback during cold pain endurance tasks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain score | 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 | Immediately after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Level | 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 | Immediately after intervention |
| Cold pain endurance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Childrens Hospital Stanford | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Control (No non-visual immersive technology-based audio biofeedback) | Behavioral | Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback. |
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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. |
| Periprocedural |
| ISO Ergonomic scale | The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) | immediately after intervention |
| System Usability Scale (SUS) Score | The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) | immediately after intervention |
| Device satisfaction | 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. | immediately after intervention |