NOICE vs. Nothing | Thermode

Stanford University

Status: Not yet enrolling

Conditions: Spatial Audio Stimulation

Treatments: Behavioral: Spatial audio stimulation; Behavioral: No spatial audio stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06919497

80078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Spatial audio stimulation

Experimental group

Description:

Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study.

Treatment:

Behavioral: No spatial audio stimulation

Behavioral: Spatial audio stimulation

No spatial audio stimulation

Experimental group

Description:

Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study.

Treatment:

Behavioral: No spatial audio stimulation

Behavioral: Spatial audio stimulation