Impacts of Music-based Intervention on Pain in Individuals With Irritable Bowel Syndrome (IBS): A Mechanistic Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Yale University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- IBS visceral pain index
Study Overview
Brief 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:
- . 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Music intervention (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Perceived Stress Scale-10 (PSS-10)(through study completion, an average of 1 year)
- Feasibility of using new technology in outcome measurements(From enrollment to the end of treatment at 4 weeks)
- Intervention Adherence(through study completion, an average of 1 year)
- Data recording completeness(through study completion, an average of 1 year)
- Participant satisfaction(From intervention enrollment to the end of treatment at 4 weeks)
Investigators
Weizi Wu
Postdoctoral Associate
Yale University