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NCT03083977 · ClinicalTrials.gov registry record · NA
Examining the Effects of Processed Music on Chronic Pain
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT03083977: Clinical Trial NA study, sponsored by Indiana University.
NCT03083977 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03083977, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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 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
Primary Outcome
Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Interventions
- OTHER Safe and Sound Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-06-22 |
| Est. Completion | 2019-08-28 |
| Phase | NA |
Why NCT03083977 stopped before completion
NCT03083977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Safe and Sound Protocol is the first listed.
NCT03083977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03083977 about?
NCT03083977 is a clinical study titled "Examining the Effects of Processed Music on Chronic Pain". 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 pa...
What is the current status of trial NCT03083977?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2017-06-22. Estimated completion is 2019-08-28.
What interventions are being tested in trial NCT03083977?
The interventions under investigation include: Safe and Sound Protocol (OTHER).
Who is sponsoring clinical trial NCT03083977?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03083977's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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