The Impact of Music on Nociceptive Processing

NCT ID: NCT04087564

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2023-05-23

Brief Summary

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The investigators are studying the ways that different music may change pain perception

Detailed Description

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In this study, the investigators are comparing healthy individuals to HIV and Fibromyalgia patients. The investigators are measuring the differences in pain processing between subject groups in the presence and absence of different music and distraction conditions. The investigators will be using Quantitative Sensory Testing (QST) in order to induce varying pain conditions on the participants. The investigators will also have participants complete sets of psychosocial questionnaires. Patients with Fibromyalgia tend to have a higher pain sensitivity. Additionally, patients with an HIV diagnosis tend to be prescribed opioid medications. The investigators would like to find out if music can modulate pain, and in turn help reduce the amount of opioid medications those with a chronic pain diagnosis take.

Conditions

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Pain, Acute Pain, Chronic Anxiety Anxiety Disorders Catastrophization Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each subject serves as their own control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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music intervention

Healthy volunteers, and patients diagnosed with HIV or fibromyalgia will complete 4 rounds of QST testing; baseline + 3 music conditions to determine effect of music on pain sensitivity.

Group Type EXPERIMENTAL

music intervention

Intervention Type OTHER

The music intervention (Unwind), developed by the investigators collaborators at the Sync Project, is a machine learning protocol that generates specific sounds and phrases of music that are stitched into a music track in response to user-reported pain, anxiety and catastrophizing scales. Unwind is delivered via a web application on a smart phone.

Participants will also listen to white noise and their favorite music throughout the study session

Interventions

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music intervention

The music intervention (Unwind), developed by the investigators collaborators at the Sync Project, is a machine learning protocol that generates specific sounds and phrases of music that are stitched into a music track in response to user-reported pain, anxiety and catastrophizing scales. Unwind is delivered via a web application on a smart phone.

Participants will also listen to white noise and their favorite music throughout the study session

Intervention Type OTHER

Other Intervention Names

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Unwind Favorite Music White Noise

Eligibility Criteria

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Inclusion Criteria

* aged \>18 years
* able to speak and understand English
* willingness to undergo psychophysical and psychosocial testing.


* aged \>18 years
* have a diagnosis of fibromyalgia with concurrent chronic pain for \> 6 months, and meet the Wolfe et al 2011 research criteria for fibromyalgia
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able to speak and understand English.

Exclusion Criteria

* diagnosed hearing loss
* diagnosis of chronic pain/neuropathy
* history of chronic opioid use (having an opioid prescription \>30 days).


--diagnosed hearing loss.

HIV Patients with chronic pain: N=70

* aged \>18- years
* have a diagnosis of HIV infection
* have had chronic pain with onset \> 6 months
* have an average self-reported pain score of 4/10 or greater
* willing to undergo psychophysical and psychosocial testing
* able speak and understand English.


--diagnosed hearing loss.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristin Schreiber

Assistant Professor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin L Schreiber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Wilson JM, Franqueiro AR, Edwards RR, Chai PR, Schreiber KL. Individuals with fibromyalgia report greater pain sensitivity than healthy adults while listening to their favorite music: the contribution of negative affect. Pain Med. 2024 May 2;25(5):352-361. doi: 10.1093/pm/pnae005.

Reference Type DERIVED
PMID: 38291916 (View on PubMed)

Colebaugh CA, Wilson JM, Flowers KM, Overstreet D, Wang D, Edwards RR, Chai PR, Schreiber KL. The Impact of Varied Music Applications on Pain Perception and Situational Pain Catastrophizing. J Pain. 2023 Jul;24(7):1181-1192. doi: 10.1016/j.jpain.2023.01.006. Epub 2023 Jan 14.

Reference Type DERIVED
PMID: 36646399 (View on PubMed)

Other Identifiers

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2019P000824

Identifier Type: -

Identifier Source: org_study_id

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