Music Intervention for Irritable Bowel Syndrome
Trial Summary
What is the purpose of 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
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you regularly use opioids or illicit substances, or have used probiotics or antibiotics within two weeks before joining.
What data supports the effectiveness of the treatment Music Intervention for Irritable Bowel Syndrome?
Research shows that music therapy can help reduce anxiety and pain in patients undergoing gastrointestinal procedures and those with colorectal cancer. This suggests that music intervention might also be beneficial for people with Irritable Bowel Syndrome by potentially easing stress and discomfort.12345
Is music intervention safe for treating irritable bowel syndrome?
How does the music intervention treatment for irritable bowel syndrome differ from other treatments?
The music intervention for irritable bowel syndrome is unique because it is a noninvasive treatment that uses music to potentially reduce anxiety and pain, unlike traditional medications or therapies. This approach has been shown to help with anxiety and pain in other conditions, such as cancer and during medical procedures, by providing stress relief and relaxation.1451112
Research Team
Weizi Wu, PhD
Principal Investigator
Yale School of Nursing
Xiaomei Cong, PhD
Principal Investigator
Yale School of Nursing
Eligibility Criteria
This trial is for individuals with Irritable Bowel Syndrome (IBS) who experience abdominal pain. Participants will use a wearable sensor belt and smartwatch to measure the effects of music on their IBS-related pain at home.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 4-week music-based intervention using an abdominal belt and smartwatch for 20 minutes during the day and at night, at least five days per week.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including data collection on pain sensitivity and gut microbiome profiles.
Treatment Details
Interventions
- Music Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor