Visual and Auditory Neuromodulation of Pain Perception

NCT04281836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-24

No results posted yet for this 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 the investigators to determine if the use of auditory and visual (3D imaging) stimuli related to the regulation of breathing can decrease or modulate pain. Cortical responses will give additional insight into the areas related to the decreased pain threshold. The long term objective is to increase neurophysiological understanding that will improve patient care. If effective, the novel experimental methods used will help to standardize future pain evaluation techniques.

Conditions

  • Pain, Acute

Interventions

BEHAVIORAL

Interoceptive breathing awareness through use of audio and visual virtual technology aid

Participants are asked to focus on their breathing while (a) listening to their breathing sounds with headphones and (b) watching the 3-D image of their lungs inhaling and exhaling in real-time using the Oculus Rift 3D virtual imaging equipment and plethysmography belt. During this time fNIRS and tQST data will be collected (more detail provided below).

BEHAVIORAL

Interoceptive breathing awareness without use of audio or visual virtual reality

Participants are asked to focus on their breathing. During this time fNIRS and tQST data will be collected (more detail provided below).

Sponsors & Collaborators

Principal Investigators

  • Alexandre FM DaSilva, DMedSc · School of Dentistry, University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-11
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281836 on ClinicalTrials.gov