Actively Recruiting
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-08-24
40
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
U
University of Padova
Collaborating Sponsor
AI-Summary
What this Trial Is About
Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students. The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.
CONDITIONS
Official Title
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of clinically significant anxiety symptoms (DASS-21 > 4)
- Presence of symptoms related to Functional Gastrointestinal Disorders (IBS-SSS > 75)
- Ability to provide informed consent to participate in the study
- No organic gastrointestinal diseases such as ulcerative colitis
- No neurological disorders (e.g., previous head trauma, degenerative neurological disorders, stroke)
- No cardiovascular disorders (e.g., hypertension, cardiac arrhythmias)
You will not qualify if you...
- Absence of clinically significant anxiety symptoms (DASS-21 < 4)
- Absence of symptoms related to Functional Gastrointestinal Disorders (IBS-SSS < 75)
- Lack of informed consent to participate
- Presence of organic gastrointestinal diseases such as ulcerative colitis
- Presence of neurological disorders (e.g., previous head trauma, degenerative neurological disorders, stroke)
- Presence of cardiovascular disorders (e.g., hypertension, cardiac arrhythmias)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eleonora Volpato
Milan, Italy, 20123
Actively Recruiting
Research Team
E
Eleonora Volpato, PsyD, PhD
CONTACT
E
Elisabetta Patron, PsyD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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