Clinical trial NCT06706778: The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Official title: Impacts of Music-based Intervention on Pain in Individuals with Irritable Bowel Syndrome (IBS): a Mechanistic Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Pain/ Discomfort
Irritable Bowel Syndrome
Keywords: abdominal pain
Music
Brain-gut axis
Stress
Irritable Bowel Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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:

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

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 This pilot mechanistic study is a one-arm pre- and post- intervention design. The pathways underlying neural and physiologic response to music and brain-gut interaction among IBS patients provide a cue to understand the complex interplay of outcome variables. Participants will be engaged in MBI for 20 minutes during the day and at night, at least five days a week, with the abdominal belt and smartwatch data acquisition during a four-week home-based intervention period. Throughout the study period, investigators will collect IBS pain mechanistic biobehavioral makers, including all real-time visceral pain indicators collected via the abdominal belt, real-time visual analog scale (VAS) pain report by smartwatch, and self-reported pain and stress status. Additionally, investigators will collect stool samples to investigate gut microbiome profiles and assess pain sensitivity through quantitative sensory testing (QST) equipment at two lab visits. Functional regression models and pathway analysis will determine the association between these factors.

Study Duration The pilot study will last for one year. Participants will attend two lab visits, each lasting approximately one hour. After the first lab visit, participants will be asked to engage in a music-based intervention using an abdominal belt and a smartwatch for 20 minutes, both during the day and at night, for at least five days per week. Weekly 15-minute meetings of the research assistants with each participant will be scheduled to follow up on issues encountered.

Outcome Variables Investigators will collect mechanistic biobehavioral markers of IBS pain, including real-time visceral pain indicators (electrodermal activity (EDA), electrocardiogram (ECG), and electromyogram (EMG)) via the abdominal belt, real-time visual analog scale (VAS) pain reports via the smartwatch, self-reported pain, stool samples, and quantitative pain sensitivity testing data. Additionally, investigators will assess participants' adherence to study protocols, completeness of data collection, and post-intervention satisfaction.

Locations/Facilities Participants' lab visits will take place at the Yale School of Nursing (YSN) Center for Biobehavioral Health Research and the Biobehavioral Research Laboratory (BBL). Research assistants will schedule weekly online meetings via Zoom with participants to gather feedback and address any issues encountered. Recruitment will be conducted through advertisements at collaborating gastrointestinal (GI) specialist offices and clinics affiliated with Yale New Haven Hospital. An advertising poster will be attached to bulletin boards on Yale west and main campus in order to draw attention from prospective participants.

Eligibility criteria: 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.

Primary outcomes:
measure: IBS visceral pain index
timeFrame: From intervention enrollment to the end of treatment at 4 weeks
measure: Real-time self-reported pain
timeFrame: From intervention enrollment to the end of treatment at 4 weeks
measure: Brief Pain Inventory
timeFrame: through study completion, an average of 1 year
measure: Pain sensitivity
timeFrame: through study completion, an average of 1 year
measure: IBS-quality of life (IBS-QOL)
timeFrame: through study completion, an average of 1 year
measure: 16S rRNA Gene-based Analysis of Gut Microbiota
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Perceived Stress Scale-10 (PSS-10)
timeFrame: through study completion, an average of 1 year
measure: Feasibility of using new technology in outcome measurements
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Intervention Adherence
timeFrame: through study completion, an average of 1 year
measure: Data recording completeness
timeFrame: through study completion, an average of 1 year
measure: Participant satisfaction
timeFrame: From intervention enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Nursing
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Weizi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Nursing
name: Xiaomei Cong, PhD
role: PRINCIPAL_INVESTIGATOR
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