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WithdrawnNCT06919497Updated May 18, 2026

NOICE vs. Nothing | Thermode

An interventional study of Spatial audio stimulation and No spatial audio stimulation in Spatial Audio Stimulation, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
The investigator has no intention to initiate the study at this moment.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spatial Audio Stimulation

Keywords

  • Thermal Sensory Analyzer (TSA-II)
  • Peltier-Based Contact Thermode
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Behavioral: Spatial audio stimulation · Behavioral: No spatial audio stimulation

  • 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.

    Behavioral: Spatial audio stimulation · Behavioral: No spatial audio stimulation

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.

06

What researchers measure

Primary outcomes

  1. Change in heat pain threshold

    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.

    Time frame: Duration of intervention, approximately 15 minutes

Secondary outcomes

  1. Change in heat pain sensitivity (HPS)

    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.

    Time frame: immediately after intervention

  2. 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

    Time frame: immediately after intervention

  3. ISO Ergonomic scale

    The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

    Time frame: immediately after intervention

  4. System Usability Scale (SUS) Score

    The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

    Time frame: immediately after intervention

  5. 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.

    Time frame: immediately after intervention

07

Study locations

1 site
  • Lucile Packard Children's Hospital Stanford
    Palo Alto, California 94304, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06919497
Lead sponsor
Stanford University
Responsible party
Thomas Caruso (Clinical Professor, Stanford University) — Principal investigator
First posted
Apr 9, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
May 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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