NOICE vs. Nothing | Thermode
NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spatial audio stimulation
Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study.
|
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. 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. |
|
Experimental: No spatial audio stimulation
Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study.
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in heat pain threshold
Time Frame: 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.
|
Duration of intervention, approximately 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in heat pain sensitivity (HPS)
Time Frame: 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.
|
immediately after intervention
|
|
ISO Ergonomic scale
Time Frame: immediately after intervention
|
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
Time Frame: immediately after intervention
|
The scale has 10 items.
Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
|
immediately after intervention
|
|
Anxiety Level
Time Frame: 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
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immediately after intervention
|
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Device satisfaction
Time Frame: 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.
|
immediately after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 80078
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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