30 Participants Needed

Music Intervention for Irritable Bowel Syndrome

XC
WW
Overseen ByWeizi Wu, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you regularly use opioids or illicit substances, or have used probiotics or antibiotics within two weeks before joining.

What data supports the effectiveness of the treatment Music Intervention for Irritable Bowel Syndrome?

Research shows that music therapy can help reduce anxiety and pain in patients undergoing gastrointestinal procedures and those with colorectal cancer. This suggests that music intervention might also be beneficial for people with Irritable Bowel Syndrome by potentially easing stress and discomfort.12345

Is music intervention safe for treating irritable bowel syndrome?

The research articles provided do not contain specific safety data on music intervention for irritable bowel syndrome or other conditions. Therefore, no relevant safety information is available from these sources.678910

How does the music intervention treatment for irritable bowel syndrome differ from other treatments?

The music intervention for irritable bowel syndrome is unique because it is a noninvasive treatment that uses music to potentially reduce anxiety and pain, unlike traditional medications or therapies. This approach has been shown to help with anxiety and pain in other conditions, such as cancer and during medical procedures, by providing stress relief and relaxation.1451112

Research Team

WW

Weizi Wu, PhD

Principal Investigator

Yale School of Nursing

XC

Xiaomei Cong, PhD

Principal Investigator

Yale School of Nursing

Eligibility Criteria

This trial is for individuals with Irritable Bowel Syndrome (IBS) who experience abdominal pain. Participants will use a wearable sensor belt and smartwatch to measure the effects of music on their IBS-related pain at home.

Inclusion Criteria

I am willing to join a 4-week study and can go to two lab visits.
Having daily access to an internet-enabled device for MBI
Can speak and read English
See 2 more

Exclusion Criteria

Having a severe psychiatric disorder requiring inpatient treatment in the past six months
I use opioids or illicit substances regularly, or have taken antibiotics or probiotics within the last two weeks.
Concurrently participate in another IBS-related intervention study
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-week music-based intervention using an abdominal belt and smartwatch for 20 minutes during the day and at night, at least five days per week.

4 weeks
2 visits (in-person), weekly online meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment, including data collection on pain sensitivity and gut microbiome profiles.

48 weeks

Treatment Details

Interventions

  • Music Intervention
Trial Overview The study tests how a Music-Based Intervention (MBI) affects IBS-related pain, stress responses, sensitivity to pain, and gut microbiome profiles. It involves daily 20-minute sessions of MBI over four weeks and two one-hour lab visits.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Music groupExperimental Treatment1 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 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.

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Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Findings from Research

A study involving 50 patients and 69 healthcare professionals found that implementing music intervention in colorectal surgery can significantly reduce preoperative and postoperative anxiety, with median anxiety scores decreasing from 4.5 to 3.0 after surgery.
The research identified that both patients and healthcare professionals generally supported the implementation of music in perioperative care, indicating a high likelihood of successful integration into standard practices.
Implementation of music in colorectal perioperative standard care-barriers and facilitators among patients and healthcare professionals.Kakar, E., van Ruler, O., van Straten, B., et al.[2022]
Irritable bowel syndrome (IBS) affects 10-20% of the population, particularly women, and significantly impacts quality of life, necessitating a multifaceted treatment approach that includes dietary, lifestyle, behavioral, and pharmacologic therapies.
Calcium polycarbophil has been identified as a beneficial treatment for IBS patients experiencing constipation or alternating diarrhea and constipation, highlighting the importance of tailored therapies based on individual symptoms.
Management of irritable bowel syndrome.Torii, A., Toda, G.[2019]
A review of 22 pediatric studies on music-based interventions highlighted significant gaps in how these interventions are reported, particularly in areas like music qualities and intervention delivery methods.
The findings suggest a need for standardized reporting guidelines to enhance the clarity and effectiveness of music-based interventions in research and practice.
A review of music-based intervention reporting in pediatrics.Robb, SL., Carpenter, JS.[2022]

References

Music in the endoscopy suite: a meta-analysis of randomized controlled studies. [2007]
The Effect of Music Listening on Pain in Adults Undergoing Colonoscopy: A Systematic Review and Meta-Analysis. [2021]
Implementation of music in colorectal perioperative standard care-barriers and facilitators among patients and healthcare professionals. [2022]
Frequently overlooked and rarely listened to: music therapy in gastrointestinal endoscopic procedures. [2019]
Music Therapy: A Noninvasive Treatment to Reduce Anxiety and Pain of Colorectal Cancer Patients-A Systemic Literature Review. [2023]
Treatment of irritable bowel syndrome using complementary and alternative medicine. [2021]
Management of irritable bowel syndrome. [2019]
Heart Rate Variability-An Index of the Efficacy of Complementary Therapies in Irritable Bowel Syndrome: A Systematic Review. [2022]
Hybrid Cognitive Behavioral Therapy With Interoceptive Exposure for Irritable Bowel Syndrome: A Feasibility Study. [2021]
Irritable bowel syndrome: an update on therapeutic modalities. [2022]
A review of music-based intervention reporting in pediatrics. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
A music intervention to reduce anxiety prior to gastrointestinal procedures. [2019]