Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

Part of paid clinical trials in Storrs, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT06381921
Status
Recruiting
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Conditions

  • Abdominal Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • IBS-PPSM intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

Pain intensity and interference [ Time Frame: Baseline and 4-week follow-up; Weekly Online Logs ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vernon Cottage, Depot CampusStorrsConnecticut06269
Maria Groza
[email protected]
573-529-9499
Stephen Kenton
[email protected]

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By research site
Vernon Cottage, Depot Campus· Storrs, CT

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