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

Starting soon · Not applicable

Conditions studied: Abdominal Pain/ Discomfort, Irritable Bowel Syndrome

In brief

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 facts

Study ID

NCT06706778

Run by

Yale University

People needed

30

Starts

2026-08-01

Expected to finish

2027-03-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged between 18 and 50 years old,
• can speak and read English,
• having a confirmed diagnosis of IBS from a healthcare provider,
• having experienced moderate pain (≥3 out of 10 on a numeric rating scale) at least four days a week for the past three months,
• be willing to participate in a 4-week intervention and attend two lab visits, and
• having daily access to an internet-enabled device for MBI.

You may not qualify if…

• having a severe psychiatric disorder requiring inpatient treatment in the past six months,
• regularly using opioids or illicit substances, or have used probiotics or antibiotics within two weeks prior to enrollment,
• having celiac disease, inflammatory bowel disease, or a history of major gastrointestinal surgery,
• concurrently participate in another IBS-related intervention study.

Where it is running

• Yale School of Nursing — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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