The Impact of Music Therapy on Nociceptive Processing

NCT ID: NCT03692247

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2018-07-18

Brief Summary

The purpose of this study is to understand the use of brief, personalized music interventions to decrease pain. Persisting and recurring pain is devastating to individuals and society. The worry and anxiety people feel while experiencing chronic pain may increase how much pain they feel. Enjoyable music feels good and affects brain chemicals in a way that can lessen feelings of pain. Music that feels good can also lower the anxiety and worry that accompany chronic pain which may play a role in the pain relief music provides.

Detailed Description

Chronic pain is devastating to individuals and society. Individuals who experience chronic pain have poorer health outcomes, utilize increased healthcare resources and have higher rates of disability. At present, treatment of chronic pain is limited to behavioral interventions and pharmacologic interventions. Many individuals with chronic pain will use opioid analgesics at some point in the continuum of pain. Prolonged use of opioid analgesics--even for durations as short as 3 days puts individuals at risk for nonmedical opioid use, addiction, and may fuel transitions from oral opioids to heroin.

Outside of the original insult precipitating chronic pain, increasing evidence suggests that individual factors such as anxiety and catastrophizing are associated with development of chronic pain and increased painful response to stimuli. It is therefore suggestive that treating underlying causes of anxiety and catastrophizing may lead to novel adjunctive therapies to manage chronic pain.

Music is emotive and known to modulate affect. Music that "feels good" has been described to modulate the dopaminergic and serotonin reward pathways in the brain thereby improving positive affect. Improved affect counteracts negatively valenced affect like depression, anxiety, and catastrophizing, and may be able to modulate the individual response to pain. The purpose of this pilot study is to investigate the acceptability and feasibility of a smartphone-based app on healthy volunteers.

In order to measure the impact of the music app on individual responses to pain, the investigators will use quantitative sensory testing (QST) to induce a mild-moderate, standardized pain stimulus, and measure participants' pain in the absence and presence of this music intervention. The QST is a 10 minute session that includes a set of sensory tests, which elicit a mild to moderate painful response, including a pressure pain threshold and tolerance using a handheld digital algometer, the temporal summation of pain using a set of weighted pinprick probes, and immersing hand in cold water. Primary outcome will be the modulation of pain scores by music, and secondary outcomes will include the impact of music on anxiety and catastrophizing, using brief, validated questionnaires, and whether changes in these measures of affect mediate any impact on pain processing.

Conditions

Pain; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Quantitative Sensory Testing

After answering brief questionnaires assessing psychosocial factors related to anxiety, catastrophizing, and pain, participants will undergo quantitative sensory tests where they will use a simple numeric rating scale (0-10) to rate pain and anxiety at several points during two QST sessions. During the second QST session, participants will use Unwind, a smartphone-based music intervention.

Group Type: OTHER

Smartphone-based Music Intervention

Intervention Type: OTHER

The smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone.

Interventions

Smartphone-based Music Intervention

The smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 years old
• Able to sign English written consent
• No history of chronic opioid use (have an opioid prescription more than 30 days).

Exclusion Criteria

• Under 18 years old
• Non-English speaking
• Unwilling to undergo quantitative sensory testing
• Hearing loss
• Diagnosis of neuropathy
• History of chronic opioid use (having an opioid prescription more than 30 days).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Edward W Boyer

Director of Academic Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Boyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Brookline, Massachusetts, United States

Countries

United States

Other Identifiers

2017P002872

Identifier Type: -

Identifier Source: org_study_id