Pain, AcuteNCT04281836
Visual and Auditory Neuromodulation of Pain Perception
A study testing Interoceptive breathing awareness through use of audio and visual virtual technology aid and Interoceptive breathing awareness without use of audio or visual virtual reality in people with Pain, Acute, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Interoceptive breathing awareness through use of audio and visual virtual technology aid and Interoceptive breathing awareness without use of audio or visual virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2016to 1 Dec 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-60
- Healthy subjects with no ongoing medical conditions
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
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.
Read more
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.
Read the 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:
- 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).
- 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:
- Participants will be asked to relax for five minutes to allow baseline data collection of the patient's resting functional state.
- 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.
- 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.
- 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).
- Conditions
- Pain, Acute
- Being tested
- Interoceptive breathing awareness through use of audio and visual virtual technology aid, Interoceptive breathing awareness without use of audio or visual virtual reality
- Keywords
- fNIRS, Virtual Reality (VR), Breathing focusing based meditation
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive breathing awareness through use of audio and visual virtual technology aidBehavioural
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).
Interoceptive breathing awareness without use of audio or visual virtual realityBehavioural
Participants are asked to focus on their breathing. During this time fNIRS and tQST data will be collected (more detail provided below).
| Study group | Role | What they receive |
|---|---|---|
| Breathing awareness through use of virtual reality breathing | Experimental | Healthy participants were recruited in this group. Receives: 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. Receives: Behavioral: Interoceptive breathing awareness without use of audio or visual virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start11 Feb 2016
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, MS, University of Michigan
- Investigators
- Alexandre FM DaSilva, DMedSc, Principal investigator, School of Dentistry, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281836
- Sponsor's protocol ID
- HUM00100981
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Auditory Neuromodulation of Pain Perception
- ClinicalTrials.gov ID
- NCT04281836
- Acronym / sponsor ID
- HUM00100981
- Conditions
- Pain, Acute
- Keywords
- fNIRS, Virtual Reality (VR), Breathing focusing based meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Feb 2020 (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.
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:
- 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).
- 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:
- Participants will be asked to relax for five minutes to allow baseline data collection of the patient's resting functional state.
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing awareness through use of virtual reality breathing | Experimental | Behavioral: Interoceptive breathing awareness through use of audio and visual virtual technology aidHealthy participants were recruited in this group. |
| Traditional breathing awareness | Active comparator | Behavioral: Interoceptive breathing awareness without use of audio or visual virtual realityHealthy participants were recruited in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18-60
- Healthy subjects with no ongoing medical conditions
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Interoceptive breathing awareness through use of audio and visual virtual technology aidParticipants 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). | Behavioural | Breathing awareness through use of virtual reality breathing |
| Interoceptive breathing awareness without use of audio or visual virtual realityParticipants are asked to focus on their breathing. During this time fNIRS and tQST data will be collected (more detail provided below). | Behavioural | Traditional breathing awareness |
Primary outcome
Change in pain threshold
Time frame: Baseline, 7 days
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.
The Positive and Negative Affect Schedule (PANAS) Score
Time frame: Baseline (day 1)
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.
The Positive and Negative Affect Schedule (PANAS) Score
Time frame: Day 7
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.
Functional near-infrared spectroscopy (fNIRS) neuroimaging data
Time frame: Baseline (day 1)
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.
Functional near-infrared spectroscopy (fNIRS) neuroimaging data
Time frame: Day 7
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.
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 24 Feb 2020.
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
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.
Alexandre FM DaSilva, DMedSc principal investigator
School of Dentistry, University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive breathing awareness through use of audio and visual virtual technology aid and Interoceptive breathing awareness without use of audio or visual virtual reality in people with Pain, Acute, run by University of Michigan 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 2 inclusion and 13 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 24 Feb 2020. 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?
Change in pain threshold (time frame: Baseline, 7 days). The study lists 5 primary outcomes in all. 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 24 Feb 2020.