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

Overview

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.

Interventions

• Behavioral Music intervention
  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 a

Primary outcome measures

• IBS visceral pain index [Time frame: From intervention enrollment to the end of treatment at 4 weeks]
• Real-time self-reported pain [Time frame: From intervention enrollment to the end of treatment at 4 weeks]
• Brief Pain Inventory [Time frame: through study completion, an average of 1 year]
• Pain sensitivity [Time frame: through study completion, an average of 1 year]
• IBS-quality of life (IBS-QOL) [Time frame: through study completion, an average of 1 year]
• 16S rRNA Gene-based Analysis of Gut Microbiota [Time frame: through study completion, an average of 1 year]

Secondary outcome measures (5)

• Perceived Stress Scale-10 (PSS-10) [Time frame: through study completion, an average of 1 year]
• Feasibility of using new technology in outcome measurements [Time frame: From enrollment to the end of treatment at 4 weeks]
• Intervention Adherence [Time frame: through study completion, an average of 1 year]
• Data recording completeness [Time frame: through study completion, an average of 1 year]
• Participant satisfaction [Time frame: From intervention enrollment to the end of treatment at 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Yale School of Nursing — New Haven

Publications

• Huang KY, Wang FY, Lv M, Ma XX, Tang XD, Lv L. Irritable bowel syndrome: Epidemiology, overlap disorders, pathophysiology and treatment. World J Gastroenterol. 2023 Jul 14;29(26):4120-4135. doi: 10.3748/wjg.v29.i26.4120. PMID 37475846
• Burns DS, Meadows AN, Althouse S, Perkins SM, Cripe LD. Differences between Supportive Music and Imagery and Music Listening during Outpatient Chemotherapy and Potential Moderators of Treatment Effects. J Music Ther. 2018 Mar 9;55(1):83-108. doi: 10.1093/jmt/thy001. PMID 29471518
• Burns DS, Perkins SM, Tong Y, Hilliard RE, Cripe LD. Music Therapy is Associated With Family Perception of More Spiritual Support and Decreased Breathing Problems in Cancer Patients Receiving Hospice Care. J Pain Symptom Manage. 2015 Aug;50(2):225-31. doi: 10.1016/j.jpainsymman.2015.02.022. Epub 2015 Apr 1. PMID 25839735
• Burns DS. Theoretical rationale for music selection in oncology intervention research: an integrative review. J Music Ther. 2012 Spring;49(1):7-22. doi: 10.1093/jmt/49.1.7. PMID 22803255
• Orock A, Yuan T, Greenwood-Van Meerveld B. Importance of Non-pharmacological Approaches for Treating Irritable Bowel Syndrome: Mechanisms and Clinical Relevance. Front Pain Res (Lausanne). 2021 Jan 21;1:609292. doi: 10.3389/fpain.2020.609292. eCollection 2020. PMID 35295688
• Black CJ, Ford AC. Best management of irritable bowel syndrome. Frontline Gastroenterol. 2020 May 28;12(4):303-315. doi: 10.1136/flgastro-2019-101298. eCollection 2021. PMID 34249316
• Cong X, Perry M, Bernier KM, Young EE, Starkweather A. Effects of Self-Management Interventions in Patients With Irritable Bowel Syndrome: Systematic Review. West J Nurs Res. 2018 Nov;40(11):1698-1720. doi: 10.1177/0193945917727705. Epub 2017 Aug 30. PMID 28854852
• Lembo A, Sultan S, Chang L, Heidelbaugh JJ, Smalley W, Verne GN. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. 2022 Jul;163(1):137-151. doi: 10.1053/j.gastro.2022.04.017. PMID 35738725

Identifiers

NCT: NCT06706778 · 2000039033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗