Abdominal Pain/ DiscomfortNCT06706778
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
A study testing Music intervention in people with Abdominal Pain/ Discomfort and Irritable Bowel Syndrome, run by Yale University at 1 site in United States.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale School of Nursing
New Haven, Connecticut, 06477
Xiaomei Cong, PhD, 860-617-9849, xiaomei.cong@yale.edu
About this study
Official title: 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:
- . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.
- . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings.
Read more
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:
- . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week.
- . have two one-hour lab visits
Read the 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.
- Being tested
- Music intervention
- Keywords
- abdominal pain, Music, Brain-gut axis, Stress, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Music group | Experimental | 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. Receives: Behavioral: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS visceral pain index
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.
Measured: From intervention enrollment to the end of treatment at 4 weeks
Real-time self-reported pain
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.
Measured: From intervention enrollment to the end of treatment at 4 weeks
Brief Pain Inventory
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.
Measured: through study completion, an average of 1 year
Pain sensitivity
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)
Measured: through study completion, an average of 1 year
IBS-quality of life (IBS-QOL)
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.
Measured: through study completion, an average of 1 year
16S rRNA Gene-based Analysis of Gut Microbiota
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Perceived Stress Scale-10 (PSS-10)
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.
Measured: through study completion, an average of 1 year
Feasibility of using new technology in outcome measurements
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.
Measured: From enrollment to the end of treatment at 4 weeks
Intervention Adherence
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.
Measured: through study completion, an average of 1 year
Data recording completeness
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.
Measured: through study completion, an average of 1 year
Participant satisfaction
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.
Measured: From intervention enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study startDec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Abdominal Pain/ DiscomfortStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weizi Wu, PhD, Principal investigator, Yale School of NursingXiaomei Cong, PhD, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706778
- Sponsor's protocol ID
- 2000039033
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Huang KY, Wang FY, Lv M, Ma XX, Tang XD, Lv L. Irritable bowel syndrome: Epidemiology, overlap disorders, pathophysiology and treatment. World J Gastroenterol. 2023 Jul 14;29(26):4120-4135. doi: 10.3748/wjg.v29.i26.4120.
PubMed 37475846Burns DS, Meadows AN, Althouse S, Perkins SM, Cripe LD. Differences between Supportive Music and Imagery and Music Listening during Outpatient Chemotherapy and Potential Moderators of Treatment Effects. J Music Ther. 2018 Mar 9;55(1):83-108. doi: 10.1093/jmt/thy001.
PubMed 29471518Burns DS, Perkins SM, Tong Y, Hilliard RE, Cripe LD. Music Therapy is Associated With Family Perception of More Spiritual Support and Decreased Breathing Problems in Cancer Patients Receiving Hospice Care. J Pain Symptom Manage. 2015 Aug;50(2):225-31. doi: 10.1016/j.jpainsymman.2015.02.022. Epub 2015 Apr 1.
PubMed 25839735Burns DS. Theoretical rationale for music selection in oncology intervention research: an integrative review. J Music Ther. 2012 Spring;49(1):7-22. doi: 10.1093/jmt/49.1.7.
PubMed 22803255Orock A, Yuan T, Greenwood-Van Meerveld B. Importance of Non-pharmacological Approaches for Treating Irritable Bowel Syndrome: Mechanisms and Clinical Relevance. Front Pain Res (Lausanne). 2021 Jan 21;1:609292. doi: 10.3389/fpain.2020.609292. eCollection 2020.
PubMed 35295688Black CJ, Ford AC. Best management of irritable bowel syndrome. Frontline Gastroenterol. 2020 May 28;12(4):303-315. doi: 10.1136/flgastro-2019-101298. eCollection 2021.
PubMed 34249316Cong X, Perry M, Bernier KM, Young EE, Starkweather A. Effects of Self-Management Interventions in Patients With Irritable Bowel Syndrome: Systematic Review. West J Nurs Res. 2018 Nov;40(11):1698-1720. doi: 10.1177/0193945917727705. Epub 2017 Aug 30.
PubMed 28854852Lembo A, Sultan S, Chang L, Heidelbaugh JJ, Smalley W, Verne GN. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. 2022 Jul;163(1):137-151. doi: 10.1053/j.gastro.2022.04.017.
PubMed 35738725Arnold CA, Bagg MK, Harvey AR. The psychophysiology of music-based interventions and the experience of pain. Front Psychol. 2024 May 10;15:1361857. doi: 10.3389/fpsyg.2024.1361857. eCollection 2024.
PubMed 38800683de Witte M, Spruit A, van Hooren S, Moonen X, Stams GJ. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. Health Psychol Rev. 2020 Jun;14(2):294-324. doi: 10.1080/17437199.2019.1627897. Epub 2019 Jul 15.
PubMed 31167611Chen WG, Iversen JR, Kao MH, Loui P, Patel AD, Zatorre RJ, Edwards E. Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. J Neurosci. 2022 Nov 9;42(45):8498-8507. doi: 10.1523/JNEUROSCI.1135-22.2022.
PubMed 36351825Mayer EA, Ryu HJ, Bhatt RR. The neurobiology of irritable bowel syndrome. Mol Psychiatry. 2023 Apr;28(4):1451-1465. doi: 10.1038/s41380-023-01972-w. Epub 2023 Feb 2.
PubMed 36732586
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Music-based Intervention on Pain in Individuals With Irritable Bowel Syndrome (IBS): A Mechanistic Pilot Study
- ClinicalTrials.gov ID
- NCT06706778
- Acronym / sponsor ID
- 2000039033
- Keywords
- abdominal pain, Music, Brain-gut axis, Stress, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.
- . 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:
- . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week.
- . have two one-hour lab visits
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Behavioral: Music interventionBased 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionBased 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. | Behavioural | Music group |
Primary outcome
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.
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.
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.
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)
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.
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.
5 secondary outcomes
Perceived Stress Scale-10 (PSS-10)
Time frame: 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
Intervention Adherence
Time frame: through study completion, an average of 1 year
Data recording completeness
Time frame: through study completion, an average of 1 year
Participant satisfaction
Time frame: From intervention enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 37475846Huang KY, Wang FY, Lv M, Ma XX, Tang XD, Lv L. Irritable bowel syndrome: Epidemiology, overlap disorders, pathophysiology and treatment. World J Gastroenterol. 2023 Jul 14;29(26):4120-4135. doi: 10.3748/wjg.v29.i26.4120.
- Results publication: PubMed 29471518Burns DS, Meadows AN, Althouse S, Perkins SM, Cripe LD. Differences between Supportive Music and Imagery and Music Listening during Outpatient Chemotherapy and Potential Moderators of Treatment Effects. J Music Ther. 2018 Mar 9;55(1):83-108. doi: 10.1093/jmt/thy001.
- Results publication: PubMed 25839735Burns DS, Perkins SM, Tong Y, Hilliard RE, Cripe LD. Music Therapy is Associated With Family Perception of More Spiritual Support and Decreased Breathing Problems in Cancer Patients Receiving Hospice Care. J Pain Symptom Manage. 2015 Aug;50(2):225-31. doi: 10.1016/j.jpainsymman.2015.02.022. Epub 2015 Apr 1.
- Results publication: PubMed 22803255Burns DS. Theoretical rationale for music selection in oncology intervention research: an integrative review. J Music Ther. 2012 Spring;49(1):7-22. doi: 10.1093/jmt/49.1.7.
- Results publication: PubMed 35295688Orock A, Yuan T, Greenwood-Van Meerveld B. Importance of Non-pharmacological Approaches for Treating Irritable Bowel Syndrome: Mechanisms and Clinical Relevance. Front Pain Res (Lausanne). 2021 Jan 21;1:609292. doi: 10.3389/fpain.2020.609292. eCollection 2020.
- Results publication: PubMed 34249316Black CJ, Ford AC. Best management of irritable bowel syndrome. Frontline Gastroenterol. 2020 May 28;12(4):303-315. doi: 10.1136/flgastro-2019-101298. eCollection 2021.
- Results publication: PubMed 28854852Cong X, Perry M, Bernier KM, Young EE, Starkweather A. Effects of Self-Management Interventions in Patients With Irritable Bowel Syndrome: Systematic Review. West J Nurs Res. 2018 Nov;40(11):1698-1720. doi: 10.1177/0193945917727705. Epub 2017 Aug 30.
- Results publication: PubMed 35738725Lembo A, Sultan S, Chang L, Heidelbaugh JJ, Smalley W, Verne GN. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. 2022 Jul;163(1):137-151. doi: 10.1053/j.gastro.2022.04.017.
- Results publication: PubMed 38800683Arnold CA, Bagg MK, Harvey AR. The psychophysiology of music-based interventions and the experience of pain. Front Psychol. 2024 May 10;15:1361857. doi: 10.3389/fpsyg.2024.1361857. eCollection 2024.
- Results publication: PubMed 31167611de Witte M, Spruit A, van Hooren S, Moonen X, Stams GJ. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. Health Psychol Rev. 2020 Jun;14(2):294-324. doi: 10.1080/17437199.2019.1627897. Epub 2019 Jul 15.
- Results publication: PubMed 36351825Chen WG, Iversen JR, Kao MH, Loui P, Patel AD, Zatorre RJ, Edwards E. Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. J Neurosci. 2022 Nov 9;42(45):8498-8507. doi: 10.1523/JNEUROSCI.1135-22.2022.
- Results publication: PubMed 36732586Mayer EA, Ryu HJ, Bhatt RR. The neurobiology of irritable bowel syndrome. Mol Psychiatry. 2023 Apr;28(4):1451-1465. doi: 10.1038/s41380-023-01972-w. Epub 2023 Feb 2.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weizi Wu, PhD principal investigator
Yale School of Nursing
Xiaomei Cong, PhD principal investigator
Yale School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Abdominal Pain/ Discomfort and Irritable Bowel Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weizi Wu, PhD (860-634-9501, weizi.wu@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS visceral pain index (time frame: From intervention enrollment to the end of treatment at 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706778, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.