Visual and Auditory Neuromodulation of Pain Perception
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

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.
    

Detailed description: 
      The study requires seven consecutive days of participation: two in-person appointments, day 1
      and 7, and at home self-guided exercises days 2-7 Both in-person appointments will be held at
      the fNIRS lab at the University of Michigan Center for Human Growth and Development. The
      participants will be randomly divided into two even groups:

        1. Interoceptive breathing awareness through the 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).

        2. Control: Interoceptive breathing awareness without the use of audio or visual virtual
           technology aid Participants are asked to focus on their breathing. During this time
           fNIRS and tQST data will be collected (more detail provided below).

      Each in-person appointment is anticipated to last one hour, with 3x daily at-home sessions
      lasting 5 minutes each. Instructions for at-home sessions will be provided. Each participant
      is to complete all 7 sessions in 7 consecutive days plus or minus one day. The total time
      commitment is3hours 15 minutes. In the advent of equipment malfunction during a session that
      compromises or prevents data collection, the participant may be asked to return for an
      additional appointment to complete the session.

      The first session will begin with documentation of subject consent followed by the completion
      of a demographic survey. At the start of all sessions, subjects will be asked to complete
      questionnaires on their current pain levels and emotional states, including the McGill Pain
      Questionnaire (MPQ) and Positive and Negative Affect Schedule (PANAS). Baseline thermal
      quantitative sensory testing (tQST) data will also be collected by 3 trials of heat
      administration (more detail provided below). Participants will then be seated in a dental
      chair wearing headphones, Oculus Rift 3D virtual imaging equipment, plethysmography belt ,
      fNIRS sensors, thermal quantitative sensory (tQST) sensors with holding apparatus, and a
      pulse oximeter. A single, unilateral tQST sensor will be localized to the left mandibular
      nerve branch of the trigeminal cranial nerve, V3. The fNIRS sensors will be worn on the head
      and positioned for optimal brain imaging. All fNIRS data will be collected and analyzed with
      Homer 2 software. The pulse oximeter will be clipped over one finger to measure general body
      blood oxygen content during the session.

      Once the participant is seated, wearing the equipment and hooked up to the fNIRS device, the
      following will take place for the two breathing awareness experimental sessions:

        1. Participants will be asked to relax for five minutes to allow baseline data collection
           of the patient's resting functional state.

        2. After 5 minutes of baseline collection, interoceptive breathing awareness (with or
           without the use of technology) will begin for a period of 10 minutes, during which fNIRS
           and pulse oximeter data will be collected.

        3. After 10 minutes of the breathing awareness exercise, the thermal QST will begin using
           the Medoc (Israel) Pathway System. The holding apparatus with the QST system will
           administer a hot stimulus 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). The participant will control the heating
           unit with a computer keyboard. The temperature will gradually increase 1 Celsius per
           second up to 50 Celsius (122 Fahrenheit). At the first detection of pain, the subject
           will be instructed to click the keyboard space bar to stop the temperature from
           increasing. This process will be repeated twenty times to give an accurate average
           temperature value. During the 20 trials, participants will continue the interceptive
           breathing awareness and fNIRS and pulse oximeter data will continue to be collected.

        4. Upon completion of all 20 tQST trials, participants will be asked to discontinue the
           breathing awareness exercise and five minutes of resting functional state will again be
           collected. Once resting state is collected, all equipment and sensors will be turned off
           and removed from the participant, at which point the participant will again complete the
           mood and pain surveys and 3 trials of post-stimulation tQST data will be collected.

      Audio and Visual Virtual Technology: Headphones, microphone, and the Oculus Rift will be
      connected to the mobile device. Breathing sounds will be picked up by a microphone and played
      back to the participant through the headphones. The sounds of inhaling and exhaling will be
      identified by the app and the respiratory volume will be identified via a plethysmography
      belt allowing proper synchronization of the virtual lung image on the Oculus with the
      participant's own lungs. The processing and replay of this information will occur in less
      than a second allowing the participant to experience the virtual environment in real-time.
      (I.e. Participants will be able to see a 3D image of their lungs inflating and deflating,
      while at the same time listening to their breathing, for a truly immersive experience).
    

Intervention name(s): Interoceptive breathing awareness through use of audio and visual virtual technology aid; Interoceptive breathing awareness without use of audio or visual virtual reality
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; Participants are asked to focus on their breathing. During this time fNIRS and tQST data will be collected (more detail provided below).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fNIRS; Virtual Reality (VR); Breathing focusing based meditation