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Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)

NCT04296110 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-08-15

No results posted yet for this study

Summary

This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.

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.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 practice breathing at their resonance frequency using the Inner Balance device daily for 5-15 mins for the duration of the 12-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 intervention.

OTHER

Music Relaxation Therapy

We will determine what genre of music is most relaxing to them and ask them to listen to this type of music using the spotify app for 5-15 mins a day for 12 weeks. If they do not have access to a device that they can listen to spotify on, an ipod will be provided. They will be asked to complete a 2-question survey via Redcap daily that asks them if they have listened to the designated music that day and for how long.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Ross Maltz, MD · Nationwide Childrens 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
2020-03-12
Primary Completion
2024-08-14
Completion
2024-08-14

Countries

  • United States

Study Locations

More Related Trials

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 NCT04296110 on ClinicalTrials.gov