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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Music intervention
BehavioralBased 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Music groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
IBS visceral pain index
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.
Time frame
From intervention enrollment to the end of treatment at 4 weeks2
Real-time self-reported pain
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.
Time frame
From intervention enrollment to the end of treatment at 4 weeks3
Brief Pain Inventory
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.
Time frame
through study completion, an average of 1 year4
Pain sensitivity
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)
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Perceived Stress Scale-10 (PSS-10)
PSS-10 will be used to self-report the level of perceived stress in various life situations. It includes ten items rated on a 5-point scale, from "never" to "very often." The total score can range from 0 to 40, with a higher score indicating a higher stress level. The PSS has demonstrated high internal consistency and test-retest reliability.
Time frame
through study completion, an average of 1 year2
Feasibility of using new technology in outcome measurements
The feasibility of utilizing wearable devices for pain and stress measurement will be evaluated based on participant adherence to study protocols, data collection completeness, and participants' satisfaction. These data will provide insight into the practicality of integrating bio-signal monitoring technology in objective outcome measurements.
Time frame
From enrollment to the end of treatment at 4 weeks3
Intervention Adherence
Adherence will be tracked through the number of participants following the protocol over time, including daily usage patterns. Participants will log the frequency, timing, and duration of device usage in a structured online diary using the REDCap system.
Time frame
through study completion, an average of 1 year4
Data recording completeness
Data recording completeness will be assessed by analyzing device synchronization and the proportion of missing data. Retention rates will be calculated based on participant continuity throughout the study duration.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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