About this trial
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.
Eligibility criteria
Qualifiers
presence of clinically significant anxiety symptoms (DASS-21 > 4)
presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS > 75);
obtaining informed consent to participate in the study;
Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);
Disqualifiers
absence of clinically significant anxiety symptoms (DASS-21< 4);
absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS < 75);
lack of obtaining Informed Consent to participate in the study;
presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).
Trial design
Treatments tested in this trial
- HRV Biofeedback Training
- Placebo Training
Treatment groups
Sponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
University of Padova
Collaborator
Catholic University of the Sacred Heart
Collaborator