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NCT04281836 · ClinicalTrials.gov registry record · NA

Visual and Auditory Neuromodulation of Pain Perception

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT04281836: Completed NA study, sponsored by University of Michigan.

NCT04281836 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04281836, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

Medical and dental patients may experience fear commonly attributed to physical pain during the visit. By reducing pain perception, patient comfort and future patient compliance may be improved. Patient health may be improved by increasing compliance and promoting increased visits. This can lead to more frequent and timely preventative actions. The research purpose is to establish quantitative and qualitative data to support current, non-pharmacological methods for reducing pain sensitivity. More specifically, the investigators aim to determine if the use of auditory and visual (3D imaging) stimuli related to the regulation of breathing can decrease or modulate pain. Healthy participants between the ages of 18 and 60 will participate in a one week study, with two in lab appointments on day one and day seven. Participants will be split into two groups, one will undergo breathing awareness using auditory and visual technology (i.e. listen to one's own breathing with headphones and watch 3D image of lungs using virtual headset), and the second group will have breathing awareness without the use of technology (i.e. simply focusing on one's own breathing). At each appointment, the investigators will collect pain threshold data using thermal Quantitative Sensory Testing (tQST) and brain activity data using Functional near-infrared spectroscopy (fNIRS). tQST and fNIRS data will be collected before, during, and after each breathing awareness/control exercise. Quantifying change in pain intensity has been demonstrated by pain threshold comparison across a stimulus using thermal Quantitative Sensory Testing (tQST). Functional near-infrared spectroscopy (fNIRS) in coordination with pain stimulation has been shown effective at locating different hemodynamic cortical responses depending on pain perception and expectation. In the current study, functional resting states before and after pain stimulation will be quantitatively assessed using fNIRS. The study design will allow t

Primary Outcome

Pain threshold will be measured by thermal stimulation. During the thermal stimulation, a single, unilateral thermal quantitative sensor was localized to the left mandibular nerve branch of the trigeminal cranial nerve, V3. The thermal quantitative sensory test (tQST) administered a hot stimuli at a consistent location and pressure from a baseline temperature of 30 Celsius (86 Fahrenheit), for reference the average normal body temperature is 37 Celsius (98.6 Fahrenheit ), to a maximum temperatur

Interventions

  • BEHAVIORAL Interoceptive breathing awareness through use of audio and visual virtual technology aid
  • BEHAVIORAL Interoceptive breathing awareness without use of audio or visual virtual reality

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2016-02-11
Est. Completion 2019-12-01
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04281836 record still lists

NCT04281836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Interoceptive breathing awareness through use of audio and visual virtual technology aid is the first listed.

NCT04281836 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04281836 about?

NCT04281836 is a clinical study titled "Visual and Auditory Neuromodulation of Pain Perception". Medical and dental patients may experience fear commonly attributed to physical pain during the visit. By reducing pain perception, patient comfort and future patient compliance may be improved. Patient health may be improved by increasing compliance and promoting increased visits. This can lead to ...

What is the current status of trial NCT04281836?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2016-02-11. Estimated completion is 2019-12-01.

What interventions are being tested in trial NCT04281836?

The interventions under investigation include: Interoceptive breathing awareness through use of audio and visual virtual technology aid (BEHAVIORAL), Interoceptive breathing awareness without use of audio or visual virtual reality (BEHAVIORAL).

Who is sponsoring clinical trial NCT04281836?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04281836's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04281836, the US trial registry maintained by the National Library of Medicine. NCT04281836 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.