NCT07227142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

23 days

First QC Date

November 5, 2025

Last Update Submit

May 14, 2026

Conditions

Pain

Keywords

non-visual immersive technology-based audio biofeedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Anxiety Level

    Immediately after intervention

  • Cold pain endurance

    Periprocedural

  • ISO Ergonomic scale

    immediately after intervention

  • System Usability Scale (SUS) Score

    immediately after intervention

  • Device satisfaction

    immediately after intervention

Study Arms (4)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Group 4

EXPERIMENTAL

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

Interventions

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.

Group 1Group 2Group 3Group 4
Non-visual immersive technology-based audio biofeedback interventionBEHAVIORAL

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

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 5, 2025

First Posted

November 12, 2025

Study Start

March 10, 2026

Primary Completion

April 2, 2026

Study Completion

April 2, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations

US(1)