Examining the Effects of Processed Music on Chronic Pain

Study Overview
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Brief Summary
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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)

Official Title
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Examining the Effects of Processed Music on Chronic Pain

Conditions
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Pain

Intervention / Treatment
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* Other: Safe and Sound Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must self-report as suffering from chronic pain Exclusion Criteria: Individuals who do not read or speak proficient English Individuals with substantial, uncorrected hearing loss
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days | Other: Safe and Sound Protocol<br>* The intervention features music processed based on the resonating frequencies of the middle ear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form | 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 | Change over 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic Function | Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart | Change over 1 week | 
| Body perception | Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form | Change over 1 week |