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临床试验/NCT03083977
NCT03083977终止不适用

Examining the Effects of Processed Music on Chronic Pain

Indiana University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

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)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants must self-report as suffering from chronic pain

排除标准

  • Individuals who do not read or speak proficient English
  • Individuals with substantial, uncorrected hearing loss

结局指标

主要结局

Pain intensity

时间窗: Change over 1 week

Change in intensity of pain from pre-assessment to post-assessment, measured by the Brief Pain Inventory Short Form

Pain experience

时间窗: Change over 1 week

Change in experience of pain from pre-assessment to post-assessment, measured by the McGill Pain Questionnaire Short Form

次要结局

  • Autonomic Function(Change over 1 week)
  • Body perception(Change over 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Porges

Distinguished University Scientist

Indiana University

研究点 (2)

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