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Examining the Effects of Processed Music on Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03083977
Recruitment Status : Terminated (pandemic related difficulties for recruitment)
First Posted : March 20, 2017
Last Update Posted : March 7, 2022
Information provided by (Responsible Party):
Stephen Porges, Indiana University

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)

Condition or disease Intervention/treatment Phase
Pain Other: Safe and Sound Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Effects of Processed Music on Chronic Pain
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : August 28, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention group
This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days
Other: Safe and Sound Protocol
The intervention features music processed based on the resonating frequencies of the middle ear

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. Autonomic Function [ Time Frame: Change over 1 week ]
    Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart

  2. Body perception [ Time Frame: Change over 1 week ]
    Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form

Other Outcome Measures:
  1. Auditory processing [ Time Frame: Change over 1 week ]
    Auditory 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03083977

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United States, Indiana
Meadowood Retirement Community
Bloomington, Indiana, United States, 47408
Sponsors and Collaborators
Indiana University
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Principal Investigator: Stephen Porges, PhD Indiana University
Study Chair: Peter Miksza, PhD Indiana University
Study Chair: Hannah Fidler Indiana University
Study Chair: Jacek Kolacz, PhD Indiana University
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Responsible Party: Stephen Porges, Distinguished University Scientist, Indiana University Identifier: NCT03083977    
Other Study ID Numbers: 1702490842
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations