Recruiting

Observational Study

Sponsor:

University of Connecticut

Code:

NCT06381921

Conditions

Abdominal Pain

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

IBS-PPSM intervention

Study Details

Brief summary:

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.

Conditions

Abdominal Pain

Study ID

NCT06381921

Start date

Sep 8, 2025

Status verified date

Sep, 2025

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Self- reported Regular use of opioids or other illicit substances.
  • Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: IBS-PPSM intervention group

After the baseline visit, the IBS-PPSM group will receive 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. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

no intervention: IBS-control group

The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.

Interventions

IBS-PPSM intervention

IBS-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.

Primary outcome measure

  • Pain intensity and interference [ Time Frame: Baseline and 4-week follow-up; Weekly Online Logs ]
  • IBS-related symptoms [ Time Frame: Baseline and 4-week follow-up; Weekly Online Logs ]
  • Electrodermal activity (EDA) [ Time Frame: Baseline and 4-week follow-up ]
  • Electrocardiogram (ECG) [ Time Frame: Baseline and 4-week follow-up ]
  • Electromyogram (EMG) [ Time Frame: Baseline and 4-week follow-up ]
  • Objective integrated multimodal electrophysiological index [ Time Frame: Baseline and 4-week follow-up ]

Central Contacts and Locations

Central contacts

Hugo F Posada-Quintero

8604861556hugo.posada-quintero@uconn.edu

Locations

Vernon Cottage, Depot Campus

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

Maria Groza

573-529-9499maria.groza@uconn.edu

Stephen Kenton

kenton@easternct.edu

More Information

Sponsor

University of Connecticut

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • visceral pain
  • irritable bowel syndrome
  • autonomic and muscular activities
  • biosignals
  • personalized pain self-management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Connecticut on 2025-09-15.