The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06706778
Status
Not Yet Recruiting

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Conditions

  • Abdominal Pain/ Discomfort
  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Music intervention — BEHAVIORAL
    Based on the NIH toolkit and MBIs reporting guidelines, the engagement in this pilot study will be receptive by providing participants with prerecorded, preselected playlists. Participants will also receive a guided video on maximizing music's therapeutic benefits. The playlists will be purely instrumental, with a 60-80 bpm tempo, and feature melodies and harmonies designed for stress relief, including soothing, grounding, meditation, emotional release, etc. This approach is resource-efficient and easily accessible, allowing participants to integrate it into daily pain self-management strategies. Participants will be asked to engage in the MBI in the morning and at night for 30 minutes each, wearing the abdominal belt and smartwatch.

Study Details

The proposed pilot study aims to assess the underlying mechanisms of the MBI on IBS pain and the feasibility of using novel technology in the outcome measurements. The specific aims of this pilot mechanistic clinical trial are to: 1. . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles. 2. . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings. Researchers will conduct a one-arm pre- and post-music intervention among patients with Irritable Bowel Syndrome, collect the IBS pain mechanistic biobehavioral markers, and analyze the underlying pathways of the music analgesic effect. Participants will be asked to: 1. . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week. 2. . have two one-hour lab visits

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Music group
    Based on the NIH toolkit and MBIs reporting guidelines, the engagement in this pilot study will be receptive by providing participants with prerecorded, preselected playlists. Participants will also receive a guided video on maximizing music's therapeutic benefits. The playlists will be purely instrumental, with a 60-80 bpm tempo, and feature melodies and harmonies designed for stress relief, including soothing, grounding, meditation, emotional release, etc. This approach is resource-efficient and easily accessible, allowing participants to integrate it into daily pain self-management strategies. Participants will be asked to engage in the MBI in the morning and at night for 30 minutes each, wearing the abdominal belt and smartwatch.

Primary Outcome Measure

IBS visceral pain index [ Time Frame: From intervention enrollment to the end of treatment at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of NursingNew HavenConnecticut06477
Xiaomei Cong, PhD
[email protected]
860-617-9849

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By research site
Yale School of Nursing· New Haven, CT

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