IceBath: NOICE vs Nothing

Not Applicable

Not yet recruiting

• Conditions: Pain

• Registration Number: NCT07227142
• Lead Sponsor: Stanford University

Brief Summary

This prospective, randomized, 2-period crossover study seeks to evaluate the effect of the non-visual immersive technology-based audio biofeedback intervention, delivered through devices such as NOICE device or Quest 3, on cold pain threshold within participants.

Detailed Description

This study addresses the research gap in understanding how non-visual immersive technology-based audio biofeedback intervention impacts pain perception in clinical settings. It is important to explore this because non-visual immersive technology-based audio biofeedback intervention may serve as a non-pharmaceutical, non-visual immersive technology-based audio biofeedback alternative to traditional visual-based distraction methods like virtual reality.

The investigators hypothesize that participants using the non-visual immersive technology-based audio biofeedback device will report an increased 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 Virtual Reality (VR) headsets.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-05
• Study First Submitted QC: 2025-11-06
• Last Update Submitted: 2025-11-06
• Study First Posted: 2025-11-12
• Last Update Posted: 2025-11-12
• Study Start: 2026-02-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

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

Inclusion Criteria

• Ages 18 years and older
• English-speaking
• Intact hearing
• No self-reported or clinically diagnosed acute or chronic medical conditions that may 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain score	Immediately after intervention	Pain sensitivity will be measured by Numerical Rating Pain Scale. Participants will rank pain scores on a sliding scale from 0 = No Pain to 10 = Worst possible pain

Secondary Outcome Measures

Name	Time	Method
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
Cold pain endurance	Periprocedural	To evaluate Cold Pain Endurance, total time (in seconds) that the participant's hand remains immersed in ice water will be recorded. Start time is defined as the moment immediately prior to immersion, and stop time as the moment the hand is withdrawn.
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 Childrens Hospital Stanford; 🇺🇸 Palo Alto, California, United States