Visual and Auditory Neuromodulation of Pain Perception

NCT04281836 | Completed DMC

• 1 other identifier: HUM00100981
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fNIRS; Virtual Reality (VR); Breathing focusing based meditation

Outcome Measures

Primary Outcomes (5)

• Change in pain threshold

  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 temperature of 50 Celsius (122 Fahrenheit). Once the trial is initiated on the computer, the temperature on the thermal sensor gradually increased 1 Celsius per second. The participant was in control the heating unit with a remote and was instructed to push the button on the remote at the first detection of pain; this stopped the temperature from increasing and recorded the pain threshold.

  Baseline, 7 days

• The Positive and Negative Affect Schedule (PANAS) Score

  PANAS is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). The participants were asked to fill this questionnaire to report their emotional status before and after the breathing training and thermal stimulation sessions.

  Baseline (day 1)

• The Positive and Negative Affect Schedule (PANAS) Score

  PANAS is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). The participants were asked to fill this questionnaire to report their emotional status before and after the breathing training and thermal stimulation sessions.

  Day 7

• Functional near-infrared spectroscopy (fNIRS) neuroimaging data

  fNIRS is an optical neuroimaging technique. We applied 15 light emitters and 22 light detectors, yielding 45 data recording channels. We deployed these channels at bilateral prefrontal, sensory, and visual cortices to collect neuroimaging data during resting state, breathing training, and thermal stimulation sessions.

  Baseline (day 1)

• Functional near-infrared spectroscopy (fNIRS) neuroimaging data

  fNIRS is an optical neuroimaging technique. We applied 15 light emitters and 22 light detectors, yielding 45 data recording channels. We deployed these channels at bilateral prefrontal, sensory, and visual cortices to collect neuroimaging data during resting state, breathing training, and thermal stimulation sessions.

  Day 7

Study Arms (2)

Breathing awareness through use of virtual reality breathing

EXPERIMENTAL

Healthy participants were recruited in this group.

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

Traditional breathing awareness

ACTIVE COMPARATOR

Healthy participants were recruited in this group.

Behavioral: Interoceptive breathing awareness without use of audio or visual virtual reality

Interventions

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

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).

Breathing awareness through use of virtual reality breathing

Interoceptive breathing awareness without use of audio or visual virtual reality BEHAVIORAL

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

Traditional breathing awareness

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-60
• Healthy subjects with no ongoing medical conditions

You may not qualify if:

• Significant hearing and visual impairment
• Concurrent use of opioids or NSAIDs
• History or current evidence of chronic pain; recent acute pain during the past 6 months
• History of neurological disorder (e.g. epilepsy, stroke, neuropathy, neuropathic pain)
• History or current evidence of a psychotic disorder (e.g. schizophrenia) or substance abuse by Diagnostic and Statistical Manual of Mental Disorders - IV; bipolar or severe major depression
• Ongoing, unresolved disability litigation
• Use of an investigational drug or device within 30 days of study entry
• Pregnancy during course of study
• History or current evidence of respiratory distress or asthma
• History of uncontrolled endocrine disturbances (diabetes, thyroid, etc.)
• Any severe clinical condition that in the opinion of the PI interferes with the study
• Beards and/or facial hair
• Inability complete all sessions within 7 days plus or minus one day.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre FM DaSilva, DMedSc

  School of Dentistry, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 24, 2020
• Study Start: February 11, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)