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

February 2, 2026 updated by: Yale University

Impacts of Music-based Intervention on Pain in Individuals With Irritable Bowel Syndrome (IBS): A Mechanistic Pilot Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose 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. Irritable bowel syndrome (IBS) is the most common disorder of brain-gut interactions, characterized primarily by recurrent chronic abdominal pain, which severely impacts the quality of life and productivity of affected individuals, particularly women and young adults. Music-based interventions (MBIs) have shown promise in reducing pain cognitive processing and stress, potentially influencing pain perception in the brain and physiological arousal in the autonomic nervous system (ANS). Therefore, MBIs hold promising therapeutic potential for IBS pain management by targeting the overlapping mechanical pathways in the brain-gut axis (BGA).

Objectives The objective 1 is to identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.

The objective 2 is to evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings.

Study Population In this pilot study, 30 participants with diagnosis of IBS will be recruited. The study focuses on this population because recurrent abdominal pain, discomfort, and altered bowel habits are the core clinical symptoms of patients with IBS. The prevalence of IBS is around 20% in the United States, with annual direct costs of care and indirect lost study/work productivity estimated at more than $21 billion in the United States.

Number of Participants Investigators plan to recruit 30 participants diagnosed with IBS for this pilot study. The sample size is based on investigators' prior experience and the recommended sample size for a pilot study to provide precise estimates.

Study Design This pilot mechanistic study is a one-arm pre- and post- intervention design. The pathways underlying neural and physiologic response to music and brain-gut interaction among IBS patients provide a cue to understand the complex interplay of outcome variables. Participants will be engaged in MBI for 20 minutes during the day and at night, at least five days a week, with the abdominal belt and smartwatch data acquisition during a four-week home-based intervention period. Throughout the study period, investigators will collect IBS pain mechanistic biobehavioral makers, including all real-time visceral pain indicators collected via the abdominal belt, real-time visual analog scale (VAS) pain report by smartwatch, and self-reported pain and stress status. Additionally, investigators will collect stool samples to investigate gut microbiome profiles and assess pain sensitivity through quantitative sensory testing (QST) equipment at two lab visits. Functional regression models and pathway analysis will determine the association between these factors.

Study Duration The pilot study will last for one year. Participants will attend two lab visits, each lasting approximately one hour. After the first lab visit, participants will be asked to engage in a music-based intervention using an abdominal belt and a smartwatch for 20 minutes, both during the day and at night, for at least five days per week. Weekly 15-minute meetings of the research assistants with each participant will be scheduled to follow up on issues encountered.

Outcome Variables Investigators will collect mechanistic biobehavioral markers of IBS pain, including real-time visceral pain indicators (electrodermal activity (EDA), electrocardiogram (ECG), and electromyogram (EMG)) via the abdominal belt, real-time visual analog scale (VAS) pain reports via the smartwatch, self-reported pain, stool samples, and quantitative pain sensitivity testing data. Additionally, investigators will assess participants' adherence to study protocols, completeness of data collection, and post-intervention satisfaction.

Locations/Facilities Participants' lab visits will take place at the Yale School of Nursing (YSN) Center for Biobehavioral Health Research and the Biobehavioral Research Laboratory (BBL). Research assistants will schedule weekly online meetings via Zoom with participants to gather feedback and address any issues encountered. Recruitment will be conducted through advertisements at collaborating gastrointestinal (GI) specialist offices and clinics affiliated with Yale New Haven Hospital. An advertising poster will be attached to bulletin boards on Yale west and main campus in order to draw attention from prospective participants.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06477
        • Yale School of Nursing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Music intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS visceral pain index
Time Frame: From intervention enrollment to the end of treatment at 4 weeks
The sensitive objective integrated multimodal electrophysiological (OIME) index will be used as a biomarker for visceral pain evaluation, which will anticipate achieving robust and objective prediction of the pain level. Via machine learning and deep learning analysis, we will quantify the pain level based on key indices from time- and frequency-domain analysis of the objective EDA, ECG, and EMG recordings collected from the abdominal belt.
From intervention enrollment to the end of treatment at 4 weeks
Real-time self-reported pain
Time Frame: From intervention enrollment to the end of treatment at 4 weeks
The visual analog scale ranging from 0 (no pain) to 100 (highest level of pain) will be used to reflect the real-time episodes of visceral pain.
From intervention enrollment to the end of treatment at 4 weeks
Brief Pain Inventory
Time Frame: through study completion, an average of 1 year
The 9-item Brief Pain Inventory (BPI) scale sensitively assesses the severity of pain, the most painful area, the impact of pain on daily functions, medications, and the change in pain relief in the past 24 hours and the past week on a 0-10 (0= no pain or interference, 10= the worst possible pain or complete interference); A higher mean score indicates greater severity or interference. Cronbach alpha ranges from 0.77-0.91.
through study completion, an average of 1 year
Pain sensitivity
Time Frame: through study completion, an average of 1 year
We will assess participants' peripheral and central pain sensitivity using the comprehensive QST equipment established by the German Research Network on Neuropathic Pain as a protocol to examine thermal and mechanical sensory function44. The QST assessment includes (1) cutaneous mechanical pain sensitivity, which measures tolerance, threshold, temporal summation, and after-sensations; (2) heat and cold pain sensitivity, assessing threshold, tolerance, and ratings of supra-threshold stimuli; and (3) pressure pain thresholds. Quantifying sensory alterations in the IBS patient population offers insight into pain modulatory systems, both pain facilitation (hyperalgesia) and pain inhibition (hypoalgesia)
through study completion, an average of 1 year
IBS-quality of life (IBS-QOL)
Time Frame: through study completion, an average of 1 year
The IBS-QOL is a 34-item self-report questionnaire with a five-point Likert scale. It is specifically designed to measure the QOL in individuals with IBS. Total scores are calculated by adding up all the item responses, with higher scores indicating a better QOL. Psychometric evaluations have shown that the IBS-QOL is reliable, with a Cronbach's alpha of 0.96. It also demonstrates strong construct validity and is highly sensitive to detecting changes undergoing interventions.
through study completion, an average of 1 year
16S rRNA Gene-based Analysis of Gut Microbiota
Time Frame: through study completion, an average of 1 year
Our team has established the protocols for stool sample collection and processing and tested them in preliminary studies. Stool samples will be collected by a researcher-provided OMNIgene●GUT microbiome collection kit (DNA Genotek, Inc.); this easy self-collection system allows for stabilizing samples at room temperature for 14 days. RAs will provide adequate information and training to the participants about stool collection using the kits at in-person lab visits. Participants can return the samples to the repository by mail using a researcher-provided envelope. Samples will be immediately frozen upon collection at -80° C in the YSN BBL. Samples will be assigned a unique ID number, systematically entered into the specimen repository and database, and profiled by 16S rRNA Illumina sequencing. Paired-end 16S rRNA gene sequencing and analysis will be performed at the University of Connecticut Microbial Analysis, Resources, and Services (MARS) facility on an Illumina MiSeq system.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale-10 (PSS-10)
Time Frame: through study completion, an average of 1 year
PSS-10 will be used to self-report the level of perceived stress in various life situations. It includes ten items rated on a 5-point scale, from "never" to "very often." The total score can range from 0 to 40, with a higher score indicating a higher stress level. The PSS has demonstrated high internal consistency and test-retest reliability.
through study completion, an average of 1 year
Feasibility of using new technology in outcome measurements
Time Frame: From enrollment to the end of treatment at 4 weeks
The feasibility of utilizing wearable devices for pain and stress measurement will be evaluated based on participant adherence to study protocols, data collection completeness, and participants' satisfaction. These data will provide insight into the practicality of integrating bio-signal monitoring technology in objective outcome measurements.
From enrollment to the end of treatment at 4 weeks
Intervention Adherence
Time Frame: through study completion, an average of 1 year
Adherence will be tracked through the number of participants following the protocol over time, including daily usage patterns. Participants will log the frequency, timing, and duration of device usage in a structured online diary using the REDCap system.
through study completion, an average of 1 year
Data recording completeness
Time Frame: through study completion, an average of 1 year
Data recording completeness will be assessed by analyzing device synchronization and the proportion of missing data. Retention rates will be calculated based on participant continuity throughout the study duration.
through study completion, an average of 1 year
Participant satisfaction
Time Frame: From intervention enrollment to the end of treatment at 4 weeks
Post-intervention surveys will be administered to assess participant satisfaction, complemented by weekly feedback meetings to capture ongoing impressions and address any barriers to compliance.
From intervention enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Weizi Wu, PhD, Yale School of Nursing
  • Principal Investigator: Xiaomei Cong, PhD, Yale School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000039033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To ensure participant privacy and confidentiality, investigators will not share any individual participant data (IPD) with others. But this study is applying for an NIH U24 Pilot grant, which may have specific sharing requirements from the funding sponsor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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