[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570402":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":35,"responsibleParty":50,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":77,"whyStopped":19,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Music intervention",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Music intervention",[9],null,[21,25],{"name":22,"affiliation":23,"role":24},"Weizi Wu, PhD","Yale School of Nursing","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":23,"role":24},"Xiaomei Cong, PhD",[28,32],{"name":22,"role":29,"phone":30,"phoneExt":19,"email":31},"CONTACT","860-634-9501","weizi.wu@yale.edu",{"name":26,"role":29,"phone":33,"phoneExt":19,"email":34},"860-617-9849","xiaomei.cong@yale.edu",[36],{"facility":23,"status":19,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"New Haven","Connecticut","06477","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-72.92816,41.30815,{"lat":46,"lon":45},[49],{"name":26,"role":29,"phone":33,"phoneExt":19,"email":34},{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100570402","the-mechanism-underlying-the-analgesic-effect-of-the-music-of-ibs-pain-100570402",false,"NCT06706778","The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain","Impacts of Music-based Intervention on Pain in Individuals With Irritable Bowel Syndrome (IBS): A Mechanistic Pilot Study","Inclusion Criteria:\n\n* aged between 18 and 50 years old,\n* can speak and read English,\n* having a confirmed diagnosis of IBS from a healthcare provider,\n* having experienced moderate pain (≥3 out of 10 on a numeric rating scale) at least four days a week for the past three months,\n* be willing to participate in a 4-week intervention and attend two lab visits, and\n* having daily access to an internet-enabled device for MBI.\n\nExclusion Criteria:\n\n* having a severe psychiatric disorder requiring inpatient treatment in the past six months,\n* regularly using opioids or illicit substances, or have used probiotics or antibiotics within two weeks prior to enrollment,\n* having celiac disease, inflammatory bowel disease, or a history of major gastrointestinal surgery,\n* concurrently participate in another IBS-related intervention study.","ALL","18 Years","50 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","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:\n\n1. . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.\n2. . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings.\n\nResearchers 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.\n\nParticipants will be asked to:\n\n1. . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week.\n2. . have two one-hour lab visits",[70,71],"Abdominal Pain\u002F Discomfort","Irritable Bowel Syndrome",[73,74,75,76,71],"abdominal pain","Music","Brain-gut axis","Stress","NOT_YET_RECRUITING","2026-06-30",{"date":80,"type":81},"2026-07-02","ACTUAL",{"date":83,"type":64},"2026-08",{"date":85,"type":64},"2027-03",{"name":5,"class":6},1]