NOICE vs. Nothing | Thermode

Not Applicable

Not yet recruiting

• Conditions: Spatial Audio Stimulation

• Registration Number: NCT06919497
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Ages 18 years and older
• English-speaking
• Intact hearing

Exclusion Criteria

• Use chronotropic heart medications
• Use pain medications
• Current hearing loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in heat pain threshold	Duration of intervention, approximately 15 minutes	Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 50 degrees C, with higher temperatures indicating a higher heat pain threshold.

Secondary Outcome Measures

Name	Time	Method
Change in heat pain sensitivity (HPS)	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.
Anxiety Level	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
ISO Ergonomic scale	immediately after intervention	The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
System Usability Scale (SUS) Score	immediately after intervention	The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
Device satisfaction	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.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States