Examining the Effects of Processed Music on Chronic Pain
Primary Purpose
Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safe and Sound Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Pain
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
Sites / Locations
- Meadowood Retirement Community
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days
Outcomes
Primary Outcome Measures
Pain intensity
Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Pain experience
Change in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form
Secondary Outcome Measures
Autonomic Function
Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart
Body perception
Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03083977
Brief Title
Examining the Effects of Processed Music on Chronic Pain
Official Title
Examining the Effects of Processed Music on Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
pandemic related difficulties for recruitment
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This group will listen to 1 hour of processed music (Safe and Sound Protocol) for 5 days
Intervention Type
Other
Intervention Name(s)
Safe and Sound Protocol
Intervention Description
The intervention features music processed based on the resonating frequencies of the middle ear
Primary Outcome Measure Information:
Title
Pain intensity
Description
Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form
Time Frame
Change over 1 week
Title
Pain experience
Description
Change in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form
Time Frame
Change over 1 week
Secondary Outcome Measure Information:
Title
Autonomic Function
Description
Amplitude of respiratory sinus arrhythmia (RSA), a measure of myelinated vagal effects on the heart
Time Frame
Change over 1 week
Title
Body perception
Description
Autonomically-mediated body perception, measured by the Body Perception Questionnaire Short Form
Time Frame
Change over 1 week
Other Pre-specified Outcome Measures:
Title
Auditory processing
Description
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)
Time Frame
Change over 1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Porges, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Miksza, PhD
Organizational Affiliation
Indiana University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hannah Fidler
Organizational Affiliation
Indiana University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacek Kolacz, PhD
Organizational Affiliation
Indiana University
Official's Role
Study Chair
Facility Information:
Facility Name
Meadowood Retirement Community
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47408
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Examining the Effects of Processed Music on Chronic Pain
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