PainNCT03083977
Examining the Effects of Processed Music on Chronic Pain
A study testing Safe and Sound Protocol in people with Pain, run by Indiana University at 1 site in United States.
Trial summary
Chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Safe and Sound Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 28 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must self-report as suffering from chronic pain
Who cannot join
- Individuals who do not read or speak proficient English
- Individuals with substantial, uncorrected hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Meadowood Retirement Community
Bloomington, Indiana, 47408
About this study
Chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently alter autonomic functions, even when they are not directly designed to do so. It is possible that interventions that target the autonomic circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The proposed study will examine whether an intervention that targets the autonomic nervous system via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.
The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous system changed during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. An evolutionary "old" branch of this nerve innervates structures below the diaphragm and its dysfunction is linked to lower body organ and tissue pain. Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary heritage and the physics of the middle ear. This study is designed to test whether processed music designed to stimulate vagal function can decrease chronic pain. The Listening Project Protocol, the processed music used in this intervention, has previously been shown to effectively stimulate the function of the vagus nerve (see stimulus description below).
Read more
Specific Aims:
Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults.
Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain
Aim II: To examine whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful.
Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the reactivity of autonomic functions in everyday experiences (measured by the Body Perception Questionnaire, see below)
- Conditions
- Pain
- Being tested
- Safe and Sound Protocol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe and Sound ProtocolOther
The intervention features music processed based on the resonating frequencies of the middle ear
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days Receives: Other: Safe and Sound Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Measured: Change over 1 week
Pain experience
Change in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form
Measured: Change over 1 week
Secondary outcomes (2)
Autonomic Function
Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart
Measured: Change over 1 week
Body perception
Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form
Measured: Change over 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start22 Jun 2017
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Why it stopped: pandemic related difficulties for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Porges, Indiana University
- Investigators
- Stephen Porges, PhD, Principal investigator, Indiana UniversityPeter Miksza, PhD, Study chair, Indiana UniversityHannah Fidler, Study chair, Indiana UniversityJacek Kolacz, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083977
- Sponsor's protocol ID
- 1702490842
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2017
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Processed Music on Chronic Pain
- ClinicalTrials.gov ID
- NCT03083977
- Acronym / sponsor ID
- 1702490842
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: pandemic related difficulties for recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 20 Mar 2017 (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.
Chronic pain is a common ailment in aging populations and often co-occurs with altered regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit pain signals) are integrated with autonomic circuits throughout the body and therapies that are successful in reducing pain concurrently alter autonomic functions, even when they are not directly designed to do so. It is possible that interventions that target the autonomic circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The proposed study will examine whether an intervention that targets the autonomic nervous system via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.
The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous system changed during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. An evolutionary "old" branch of this nerve innervates structures below the diaphragm and its dysfunction is linked to lower body organ and tissue pain. Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary heritage and the physics of the middle ear. This study is designed to test whether processed music designed to stimulate vagal function can decrease chronic pain. The Listening Project Protocol, the processed music used in this intervention, has previously been shown to effectively stimulate the function of the vagus nerve (see stimulus description below).
Specific Aims:
Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults.
Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain
Aim II: To examine whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful.
Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the reactivity of autonomic functions in everyday experiences (measured by the Body Perception Questionnaire, see below)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Safe and Sound ProtocolThis group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must self-report as suffering from chronic pain
Key exclusion criteria (2 listed)
- Individuals who do not read or speak proficient English
- Individuals with substantial, uncorrected hearing loss
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 |
|---|---|---|
| Safe and Sound ProtocolThe intervention features music processed based on the resonating frequencies of the middle ear | Other | Intervention group |
Primary outcome
Pain intensity
Time frame: Change over 1 week
Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Pain experience
Time frame: Change over 1 week
Change in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form
2 secondary outcomes
Autonomic Function
Time frame: Change over 1 week
Body perception
Time frame: Change over 1 week
Results and safety
The study was stopped early (reason given: pandemic related difficulties for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Stephen Porges, PhD principal investigator
Indiana University
Peter Miksza, PhD study chair
Indiana University
Hannah Fidler study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe and Sound Protocol in people with Pain, run by Indiana University 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Mar 2022. 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 was stopped early (reason given: pandemic related difficulties for recruitment). Results are not available in the source record.
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?
Pain intensity (time frame: Change over 1 week). The study lists 2 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 7 Mar 2022.