Music Intervention for IBS Pain
This study is exploring how music intervention might help people aged 18-50 who have Irritable Bowel Syndrome (IBS) and experience moderate abdominal pain. Researchers want to understand the ways music affects IBS pain, stress, and even gut health. They are also testing new technology, like wearable sensors, to measure pain at home. You would participate in a 4-week music intervention, receiving pre-selected music playlists and a video guide. The study aims to see if music can reduce your pain and how it works in your body. This study is currently unclear about its recruitment status and plans to enroll 30 participants.
- Study design
- This is a pilot study with 30 participants, using a single-arm design where everyone receives the music intervention. It is not specified if participants or researchers will be aware of the treatment.
- What's involved
- You would participate in a 4-week music intervention and attend two lab visits. You would also need daily access to an unspecified device.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain levels will be tracked from enrollment through the end of treatment at 4 weeks, and then for an average of 1 year for the Brief Pain Inventory.
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The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Weizi Wu, PhD · PRINCIPAL_INVESTIGATOR · Yale School of Nursing
- Xiaomei Cong, PhD · PRINCIPAL_INVESTIGATOR · Yale School of Nursing
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- IBS visceral pain indexFrom intervention enrollment to the end of treatment at 4 weeks
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.
- Real-time self-reported painFrom intervention enrollment to the end of treatment at 4 weeks
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.
- Brief Pain Inventorythrough study completion, an average of 1 year
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.
- Pain sensitivitythrough study completion, an average of 1 year
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)
- IBS-quality of life (IBS-QOL)through study completion, an average of 1 year
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.
- 16S rRNA Gene-based Analysis of Gut Microbiotathrough study completion, an average of 1 year
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.