NCT03692247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

June 16, 2018

Last Update Submit

January 28, 2019

Conditions

Keywords

painmusic

Outcome Measures

Primary Outcomes (1)

  • Changes in Pain Sensitivity in the Presence of Music

    Change in pain sensitivity, measured as a difference in the temporal summation of pain with a mechanical stimulus between a control and music condition of testing.

    40 minutes

Study Arms (1)

Quantitative Sensory Testing

OTHER

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.

Other: Smartphone-based Music Intervention

Interventions

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.

Quantitative Sensory Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Brookline, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

PainChronic Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Boyer, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a cohort study of one group of 60 healthy volunteers without a diagnosis of neuropathy or chronic pain.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Academic Development

Study Record Dates

First Submitted

June 16, 2018

First Posted

October 2, 2018

Study Start

June 7, 2018

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations