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Completed

NCT Number: NCT07227142

IceBath: 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-visual immersive technology-based audio biofeedback intervention

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Pain score

    Time frame: 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 outcomes

  1. Anxiety Level

    Time frame: 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

  2. Cold pain endurance

    Time frame: 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.

  3. ISO Ergonomic scale

    Time frame: immediately after intervention

    The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

  4. System Usability Scale (SUS) Score

    Time frame: immediately after intervention

    The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

  5. Device satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: NOICE-Icebath

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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