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Examining the Effects of Processed Music on Chronic Pain

Examining the Effects of Processed Music on Chronic Pain

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03083977
Enrollment
8
Registered
2017-03-20
Start date
2017-06-22
Completion date
2019-08-28
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief 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 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)

Interventions

The intervention features music processed based on the resonating frequencies of the middle ear

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityChange over 1 weekChange in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Pain experienceChange over 1 weekChange in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form

Secondary

MeasureTime frameDescription
Autonomic FunctionChange over 1 weekAmplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart
Body perceptionChange over 1 weekAutonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form

Other

MeasureTime frameDescription
Auditory processingChange over 1 weekAuditory speech processing measured by ability to extract speech from background noise and understand speech with frequencies removed; measured by the SCAN Test for Auditory Processing Disorders (Keith, 2000)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026