The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorYale University
About this trial
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
Eligibility criteria
Qualifiers
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,
Disqualifiers
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 design
Treatments tested in this trial
- Music intervention
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Yale School of Nursing06477, New HavenConnecticut, United States
Sponsors and collaborators
Yale University
Lead sponsor
Source ClinicalTrials.gov