Examining the Effects of Processed Music on Chronic Pain

NCT ID: NCT03083977

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-22
• Study Completion Date: 2019-08-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Safe and Sound Protocol

Intervention Type: OTHER

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

Interventions

Safe and Sound Protocol

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

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Porges

Distinguished University Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Porges, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Peter Miksza, PhD

Role: STUDY_CHAIR

Indiana University

Hannah Fidler

Role: STUDY_CHAIR

Indiana University

Jacek Kolacz, PhD

Role: STUDY_CHAIR

Indiana University

Locations

Meadowood Retirement Community

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

1702490842

Identifier Type: -

Identifier Source: org_study_id