Examining the Effects of Processed Music on Chronic Pain

Pain Clinical Trial

Official title:

Examining the Effects of Processed Music on Chronic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03083977
• Other study ID #: 1702490842
• Status: Terminated
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: August 28, 2019

Study information

• Verified date: February 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Other:
• Safe and Sound Protocol
The intervention features music processed based on the resonating frequencies of the middle ear

Locations

Country	Name	City	State
United States	Meadowood Retirement Community	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	Autonomic Function	Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart	Change over 1 week
Secondary	Body perception	Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form	Change over 1 week