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 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)

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Other: Safe and Sound Protocol

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47408
      • Meadowood Retirement Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory processing	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)	Change over 1 week

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1702490842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No