The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
NCT ID: NCT06706778
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-01
2026-06-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Weizi Wu
Postdoctoral Associate
Principal Investigators
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Weizi Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Nursing
Xiaomei Cong, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Nursing
Locations
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Yale School of Nursing
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Burns 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.
Burns 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.
Burns 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.
Orock 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.
Black 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.
Cong 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.
Lembo 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.
Arnold 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.
de 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.
Chen 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.
Mayer 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.
Other Identifiers
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2000039033
Identifier Type: -
Identifier Source: org_study_id
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