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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03083977
Other study ID # 1702490842
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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