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Biofeedback in Pediatric Inflammatory Bowel Disease

NCT04269720 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-23

No results posted yet for this study

Summary

This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.

Conditions

Interventions

BEHAVIORAL

Biofeedback

They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques, guided imagery, and/ or self-talk.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to use this device daily for 10 mins for the duration of the 8-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the 8-week biofeedback intervention.

Sponsors & Collaborators

  • Ross Maltz

    lead OTHER

Principal Investigators

  • Ross Maltz, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2024-02-01
Completion
2025-02-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269720 on ClinicalTrials.gov