Examining the Effects of Processed Music on Chronic Pain

• ClinicalTrials.gov Identifier: NCT03083977
• Recruitment Status: Terminated
• First Posted: March 20, 2017
• Last Update Posted: March 7, 2022
• Sponsor: Indiana University
• Information provided by (Responsible Party): Stephen Porges, Indiana University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Meadowood Retirement Community

Bloomington, Indiana, United States, 47408

Sponsors and Collaborators

Indiana University

Investigators

• 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

More Information

• Responsible Party: Stephen Porges, Distinguished University Scientist, Indiana University
• ClinicalTrials.gov Identifier: NCT03083977
• Other Study ID Numbers: 1702490842
• First Posted: March 20, 2017
• Last Update Posted: March 7, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations