Music Intervention for Irritable Bowel Syndrome

Overseen By Weizi Wu, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioids, Illicit substances, Probiotics, Antibiotics

Disqualifiers: Severe psychiatric disorder, Celiac, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music can help manage pain and stress in people with Irritable Bowel Syndrome (IBS). Researchers aim to understand music's effect on pain and whether wearable technology, such as a belt and smartwatch, can track these changes at home. Participants will listen to calming music for 30 minutes each morning and night for four weeks, using playlists designed for relaxation. Suitable candidates have been diagnosed with IBS, experience moderate pain several times a week, and have internet access for the study. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage IBS symptoms through music therapy.

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 prior data suggests that this music intervention is safe for IBS patients?

Research has shown that music therapy is generally safe. Studies have found that patients often feel less stressed and anxious after music therapy. Some research has examined conditions like inflammatory bowel diseases and found that music can help manage emotions and stress, which are linked to gut health. No major reports of harmful effects from music therapy suggest it is well-tolerated. Overall, using music as therapy appears to be a safe way to help manage stress and gut health symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for irritable bowel syndrome (IBS) focus on medication, dietary changes, or stress management techniques. However, the music intervention is unique because it uses carefully curated instrumental playlists designed to relieve stress and support emotional well-being. This approach leverages the therapeutic power of music, offering a non-invasive, easily accessible method that can be seamlessly integrated into daily life. Researchers are excited because this could provide a resource-efficient way to manage IBS symptoms without the side effects often associated with medication.

What evidence suggests that this music intervention is effective for IBS?

Research has shown that music can aid individuals with stomach issues, such as irritable bowel syndrome (IBS). One study found that combining music with relaxation techniques alleviated various stomach-related symptoms. Another study demonstrated that an 8-week music program reduced IBS symptoms, with benefits lasting up to a year. Music therapy also improved feelings of sadness and fear, often associated with IBS. In this trial, participants in the music group will engage in a music intervention designed to reduce stress and enhance emotional well-being, potentially helping to manage IBS symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Weizi Wu, PhD

Principal Investigator

Yale School of Nursing

Xiaomei Cong, PhD

Principal Investigator

Yale School of Nursing

Are You a Good Fit for This Trial?

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

Can speak and read English

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

Exclusion Criteria

Concurrently participate in another IBS-related intervention study

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Music group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of music-based intervention reporting in pediatrics. Robb, SL., Carpenter, JS.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of irritable bowel syndrome. Torii, A., Toda, G.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12054544/

Impact of Relaxation and Music Intervention on Psychological ...

Short-term progressive muscular relaxation training in combination with music intervention is potentially effective for most gastrointestinal symptoms, but not ...

2.

bmccomplementmedtherapies.biomedcentral.com

bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-015-0611-x

Experiences of healing therapy in patients with irritable bowel ...

Experiences of healing therapy in patients with irritable bowel syndrome and inflammatory bowel disease.

3.

mdpi.com

mdpi.com/2077-0383/10/8/1591

Impact of BMGIM Music Therapy on Emotional State in ...

Results. An improvement was observed in the following states of mind: sadness, fear, anger, and depression. No significant effect was observed in state of mind ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S187638201630422X

A pragmatic randomised controlled trial of healing therapy ...

The overall score improvement was 12.9 units at week 6 (p < 0.001), 12.4 units at week 12 (p < 0.001) and 13.8 units at week 24 (p < 0.001). In IBD there was ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0277880

New multimodal intervention to reduce irritable bowel ...

Our findings suggest that an 8-week program of AMT improves the severity of IBS with an ongoing effect at a 12 month follow-up.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03999294

Bmgim Music Therapy Method in Reducing Stress ...

The objective of the study was to administer a treatment based on a group adaptation of the BMGIM in patients with inflammatory bowel disease (IBD) and assess ...

7.

researchgate.net

researchgate.net/publication/391375272_Impact_of_Relaxation_and_Music_Intervention_on_Psychological_and_Gastrointestinal_Health_in_Military_Recruits_A_Prospective_Study

(PDF) Impact of Relaxation and Music Intervention on ...

Conclusion Short-term progressive muscular relaxation training in combination with music intervention is potentially effective for most ...