Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06687057

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eleonora Volpato

Milan, Italy, 20123

Actively Recruiting

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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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