IceBath: NOICE vs Nothing (NOICE-Icebath)

Stanford University

Status: Begins enrollment in 1 month

Conditions: Pain

Treatments: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: Control (No non-visual immersive technology-based audio biofeedback)

Study type: Interventional

Funder types: Other

Identifiers

NCT07227142

83700

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

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

Behavioral: Non-visual immersive technology-based audio biofeedback intervention

Group 2

Experimental group

Description:

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.

Treatment:

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

Behavioral: Non-visual immersive technology-based audio biofeedback intervention

Group 3

Experimental group

Description:

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.

Treatment:

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

Behavioral: Non-visual immersive technology-based audio biofeedback intervention

Group 4

Experimental group

Description:

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.

Treatment:

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

Behavioral: Non-visual immersive technology-based audio biofeedback intervention