Precision Pain Self-Management in Young Adults With Irritable Bowel Syndrome
IBS-SM
2 other identifiers
interventional
80
1 country
2
Brief Summary
This pilot project will provide foundational information about the contextual factors of irritable bowel syndrome (IBS) related pain (pain catastrophizing, perceived stress, reactivity pain sensitivity, genetic and microbiome) on pain self-management (SM) process and outcomes. In addition, the investigators will gain insight on the potential impact of the personalized IBS-pain SM approach on pain SM behaviors and health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 4, 2019
May 1, 2019
2.2 years
October 27, 2017
May 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in pain sensitivity
Quantitative sensory testing - Change over time
Baseline and 6 weeks and 12 weeks
Change in gut microbiome
Change over time
Baseline and 6 weeks and 12 weeks
Secondary Outcomes (1)
Genetic variations (Pain-susceptibility SNPs genotyping)
Baseline
Study Arms (2)
Control
NO INTERVENTIONParticipants will be provided an online interactive platform to access electronic modules (total of 10) on: IBS-related pain neurophysiology and the brain-gut axis and self-management strategies. There is no additional intervention.
Personalized IBS Pain SM
EXPERIMENTALParticipants will be enrolled in the online platform. After completion of the modules, they will be scheduled for a consultation with a research nurse about their level of peripheral and central sensitivity, self-evaluation of IBS-pain SM, goal setting and self-monitoring of IBS-pain and physical activity. They will be asked to document their pain and all symptom SM behaviors daily for the next 10 weeks. At the 6-week follow-up visit, the researcher will review the online activities of the participant, go over the previously selected goals with the participants. The study nurse will acknowledge accomplishment of goals and assist in problem-identification and solving.
Interventions
Eligibility Criteria
You may qualify if:
- Men and women ages 18-29 years of age
- Diagnosis of IBS from a healthcare provider with a current report of pain
- Able to read and write in English
- Daily access to a computer connected to the internet
You may not qualify if:
- Other chronic painful conditions (i.e. fibromyalgia, chronic pelvic pain, or chronic interstitial cystitis)
- Infectious disease (hepatitis, HIV, MRSA)
- Celiac disease or inflammatory bowel disease
- Diabetes Mellitus
- Serious mental health conditions (ex. Bipolar disorder, schizophrenia, mania)
- Women who are pregnant or post-partum in last 3 months
- Regular use of opioids, iron supplements, prebiotics/probiotics or antibiotics, or substance abuse.
- Injury to non-dominant hand or presence of open skin lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UConn Health Center
Farmington, Connecticut, 06030, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
Related Publications (1)
Chen J, Zhang Y, Barandouzi ZA, Lee J, Zhao T, Xu W, Chen MH, Feng B, Starkweather A, Cong X. The effect of self-management online modules plus nurse-led support on pain and quality of life among young adults with irritable bowel syndrome: A randomized controlled trial. Int J Nurs Stud. 2022 Aug;132:104278. doi: 10.1016/j.ijnurstu.2022.104278. Epub 2022 Apr 30.
PMID: 35640500DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaomei Cong, PhD, RN
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Using a stratified and blocked randomization scheme.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 27, 2017
First Posted
November 6, 2017
Study Start
October 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
June 4, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- within 2 years
- Access Criteria
- Requests will be submitted through the cdRNS website
All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website. When will data be available (start and end dates)? Immediately. No end date. With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov. By what mechanism will data be made available? Data are available at cdRNS.nih.gov