Clinical trial NCT03083977: Examining the Effects of Processed Music on Chronic Pain
Official title: Examining the Effects of Processed Music on Chronic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Pain intensity
timeFrame: Change over 1 week
measure: Pain experience
timeFrame: Change over 1 week
Secondary outcomes:
measure: Autonomic Function
timeFrame: Change over 1 week
measure: Body perception
timeFrame: Change over 1 week
Other outcomes:
measure: Auditory processing
timeFrame: Change over 1 week
Locations:
city: Bloomington
country: United States
facility: Meadowood Retirement Community
state: Indiana
Study officials:
affiliation: Indiana University
name: Stephen Porges, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Peter Miksza, PhD
role: STUDY_CHAIR
affiliation: Indiana University
name: Hannah Fidler
role: STUDY_CHAIR
affiliation: Indiana University
name: Jacek Kolacz, PhD
role: STUDY_CHAIR
References: