The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.
Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain.
Men and women 18-50 years old
Able to read and speak English
Daily access to a computer with internet access.
Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.
Celiac disease or inflammatory bowel disease
Diabetes mellitus; d) Serious mental health conditions
Women during pregnancy or within 3 months post-partum period
Parallel
IBS-PPSM intervention
BehavioralIBS-PPSM intervention includes 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting.
Pain intensity and interference
Brief Pain Inventory (BPI) scale: the 9-item scale measures pain intensity and interference using 0 - 10 rating scales. Higher score indicates higher levels of pain intensity and interference.
IBS-related symptoms
Qualitative narrative data will be collected including self-reported stool frequency, quality, form, and abdominal bloating or distention symptoms. Online diary format data.
Electrodermal activity (EDA)
EDA will be recorded non-invasively via surface electrodes on an abdominal belt; unit: µS
Electrocardiogram (ECG)
ECG will be recorded non-invasively via surface electrodes on an abdominal belt; unit: mV
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University of Connecticut
Lead sponsor
Yale University
Collaborator
