IceBath: NOICE vs Nothing

NCT ID: NCT07227142

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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non-visual immersive technology-based audio biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Non-visual immersive technology-based audio biofeedback intervention

Intervention Type BEHAVIORAL

Participants receive real-time auditory feedback during cold pain endurance tasks.

Control (No non-visual immersive technology-based audio biofeedback)

Intervention Type BEHAVIORAL

Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.

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.

Group Type EXPERIMENTAL

Non-visual immersive technology-based audio biofeedback intervention

Intervention Type BEHAVIORAL

Participants receive real-time auditory feedback during cold pain endurance tasks.

Control (No non-visual immersive technology-based audio biofeedback)

Intervention Type BEHAVIORAL

Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.

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.

Group Type EXPERIMENTAL

Non-visual immersive technology-based audio biofeedback intervention

Intervention Type BEHAVIORAL

Participants receive real-time auditory feedback during cold pain endurance tasks.

Control (No non-visual immersive technology-based audio biofeedback)

Intervention Type BEHAVIORAL

Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.

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.

Group Type EXPERIMENTAL

Non-visual immersive technology-based audio biofeedback intervention

Intervention Type BEHAVIORAL

Participants receive real-time auditory feedback during cold pain endurance tasks.

Control (No non-visual immersive technology-based audio biofeedback)

Intervention Type BEHAVIORAL

Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.

Interventions

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Non-visual immersive technology-based audio biofeedback intervention

Participants receive real-time auditory feedback during cold pain endurance tasks.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Caruso

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucile Packard Childrens Hospital Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

Central Contacts

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Thomas Caruso, MD, PhD

Role: CONTACT

Phone: 6504970927

Email: [email protected]

ManYee Suen, MMedSc

Role: CONTACT

Phone: 6504970927

Email: [email protected]

Other Identifiers

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83700

Identifier Type: -

Identifier Source: org_study_id