Examining the Effects of Processed Music on Chronic Pain

NCT03083977 | Terminated

• 1 other identifier: 1702490842
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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)

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Autonomic Function

  Change over 1 week

• Body perception

  Change over 1 week

Other Outcomes (1)

• Auditory processing

  Change over 1 week

Study Arms (1)

Intervention group

EXPERIMENTAL

This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days

Other: Safe and Sound Protocol

Interventions

Safe and Sound Protocol OTHER

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

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must self-report as suffering from chronic pain

You may not qualify if:

• Individuals who do not read or speak proficient English
• Individuals with substantial, uncorrected hearing loss

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Meadowood Retirement Community

Bloomington, Indiana, 47408, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Porges, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Peter Miksza, PhD

  Indiana University

  STUDY CHAIR

• Hannah Fidler

  Indiana University

  STUDY CHAIR

• Jacek Kolacz, PhD

  Indiana University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished University Scientist

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 20, 2017
• Study Start: June 22, 2017
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)