The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain

NCT06706778 | Not Yet Recruiting DMC

• 1 other identifier: 2000039033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.. identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.
2. 2.. evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings.
3. 3.. engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week.
4. 4.. have two one-hour lab visits

Conditions

Abdominal Pain/ Discomfort; Irritable Bowel Syndrome

Keywords

abdominal pain; Music; Brain-gut axis; Stress; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (6)

• 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.

  From intervention enrollment to the end of treatment at 4 weeks

• 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.

  From intervention enrollment to the end of treatment at 4 weeks

• 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.

  through study completion, an average of 1 year

• 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)

  through study completion, an average of 1 year

• IBS-quality of life (IBS-QOL)

  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.

  through study completion, an average of 1 year

• 16S rRNA Gene-based Analysis of Gut Microbiota

  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.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• 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

Study Arms (1)

Music group

EXPERIMENTAL

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.

Behavioral: Music intervention

Interventions

Music intervention BEHAVIORAL

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.

Music group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Nursing

New Haven, Connecticut, 06477, United States

Location

Related Publications (12)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Arnold CA, Bagg MK, Harvey AR. The psychophysiology of music-based interventions and the experience of pain. Front Psychol. 2024 May 10;15:1361857. doi: 10.3389/fpsyg.2024.1361857. eCollection 2024.

  PMID: 38800683 RESULT

• de Witte M, Spruit A, van Hooren S, Moonen X, Stams GJ. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. Health Psychol Rev. 2020 Jun;14(2):294-324. doi: 10.1080/17437199.2019.1627897. Epub 2019 Jul 15.

  PMID: 31167611 RESULT

• Chen WG, Iversen JR, Kao MH, Loui P, Patel AD, Zatorre RJ, Edwards E. Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. J Neurosci. 2022 Nov 9;42(45):8498-8507. doi: 10.1523/JNEUROSCI.1135-22.2022.

  PMID: 36351825 RESULT

• Mayer EA, Ryu HJ, Bhatt RR. The neurobiology of irritable bowel syndrome. Mol Psychiatry. 2023 Apr;28(4):1451-1465. doi: 10.1038/s41380-023-01972-w. Epub 2023 Feb 2.

  PMID: 36732586 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Weizi Wu, PhD

  Yale School of Nursing

  PRINCIPAL INVESTIGATOR

• Xiaomei Cong, PhD

  Yale School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weizi Wu, PhD

CONTACT

860-634-9501; weizi.wu@yale.edu

Xiaomei Cong, PhD

CONTACT

860-617-9849; xiaomei.cong@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)