PainNOICE-IcebathNCT07227142
IceBath: NOICE vs Nothing
A study testing Non-visual immersive technology-based audio biofeedback intervention in people with Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Non-visual immersive technology-based audio biofeedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Non-visual immersive technology-based audio biofeedback intervention, Control (No non-visual immersive technology-based audio biofeedback)
- Keywords
- non-visual immersive technology-based audio biofeedback
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-visual immersive technology-based audio biofeedback interventionBehavioural
Participants receive real-time auditory feedback during cold pain endurance tasks.
Control (No non-visual immersive technology-based audio biofeedback)Behavioural
Participants complete the same cold pain endurance tasks without any non-visual immersive technology-based auditory feedback.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: 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. Receives: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: 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. Receives: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: 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. Receives: Behavioral: Non-visual immersive technology-based audio biofeedback intervention; Behavioral: Control (No non-visual immersive technology-based audio biofeedback) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after intervention
Secondary outcomes (5)
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
Measured: 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.
Measured: Periprocedural
ISO Ergonomic scale
The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
Measured: 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)
Measured: 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.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start10 Mar 2026
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227142
- Sponsor's protocol ID
- 83700
- Acronym
- NOICE-Icebath
- Status last verified
- May 2026
- First submitted
- 5 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOICE: A Prospective, Randomized, Crossover Study (NOICE vs. Nothing)
- ClinicalTrials.gov ID
- NCT07227142
- Acronym / sponsor ID
- NOICE-Icebath / 83700
- Conditions
- Pain
- Keywords
- non-visual immersive technology-based audio biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Non-visual immersive technology-based audio biofeedback intervention, Behavioral: Control (No non-visual immersive technology-based audio biofeedback)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 2 | Experimental | Behavioral: Non-visual immersive technology-based audio biofeedback intervention, Behavioral: Control (No non-visual immersive technology-based audio biofeedback)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 3 | Experimental | Behavioral: Non-visual immersive technology-based audio biofeedback intervention, Behavioral: Control (No non-visual immersive technology-based audio biofeedback)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 4 | Experimental | Behavioral: Non-visual immersive technology-based audio biofeedback intervention, Behavioral: Control (No non-visual immersive technology-based audio biofeedback)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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-visual immersive technology-based audio biofeedback interventionParticipants receive real-time auditory feedback during cold pain endurance tasks. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| 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. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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
5 secondary outcomes
Anxiety Level
Time frame: Immediately after intervention
Cold pain endurance
Time frame: Periprocedural
ISO Ergonomic scale
Time frame: immediately after intervention
System Usability Scale (SUS) Score
Time frame: immediately after intervention
Device satisfaction
Time frame: immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-visual immersive technology-based audio biofeedback intervention in people with Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.