The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain (NCT06706778) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
United States30 participantsStarted 2026-03
Plain-language summary
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
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IBS visceral pain index
Timeframe: From intervention enrollment to the end of treatment at 4 weeks
2
Real-time self-reported pain
Timeframe: From intervention enrollment to the end of treatment at 4 weeks
3
Brief Pain Inventory
Timeframe: through study completion, an average of 1 year
4
Pain sensitivity
Timeframe: through study completion, an average of 1 year
5
IBS-quality of life (IBS-QOL)
Timeframe: through study completion, an average of 1 year
6
16S rRNA Gene-based Analysis of Gut Microbiota
Timeframe: through study completion, an average of 1 year