IceBath: NOICE vs Nothing (NOICE-Icebath)

NOICE: A Prospective, Randomized, Crossover Study (NOICE vs. Nothing)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: Control (No non-visual immersive technology-based audio biofeedback)

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Childrens Hospital Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants first perform the task with non-visual immersive technology-based audio biofeedback using the dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the non-dominant hand.	Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Participants receive real-time auditory feedback during cold pain endurance tasks.; Behavioral: Control (No non-visual immersive technology-based audio biofeedback); Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.
Experimental: Group 2; Participants first perform the task with non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the dominant hand.	Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Participants receive real-time auditory feedback during cold pain endurance tasks.; Behavioral: Control (No non-visual immersive technology-based audio biofeedback); Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.
Experimental: Group 3; Participants first perform the task without non-visual immersive technology-based audio biofeedback using the dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the non-dominant hand.	Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Participants receive real-time auditory feedback during cold pain endurance tasks.; Behavioral: Control (No non-visual immersive technology-based audio biofeedback); Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.
Experimental: Group 4; Participants first perform the task without non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the dominant hand.	Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Participants receive real-time auditory feedback during cold pain endurance tasks.; Behavioral: Control (No non-visual immersive technology-based audio biofeedback); Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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	Immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISO Ergonomic scale	The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)	immediately after intervention
System Usability Scale (SUS) Score	The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)	immediately after intervention
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.	immediately after intervention
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	Immediately after intervention
Cold pain endurance	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.	Periprocedural

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Actual): April 2, 2026
• Study Completion (Actual): April 2, 2026

Study Registration Dates

• First Submitted: November 5, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Actual): November 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: non-visual immersive technology-based audio biofeedback
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 83700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No