NCT06919497

NOICE vs. Nothing | Thermode

NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spatial Audio Stimulation

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	No 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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-04-09
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States