Heart rate variability biofeedback increases baroreflex gain and peak expiratory flow.
Paul M Lehrer, Evgeny Vaschillo, Bronya Vaschillo...
https://pubmed.ncbi.nlm.nih.gov/14508023Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06687057
A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptoms of Functional Gastrointestinal Disorders (FGID) in College Students
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-08-24
40
Participants Needed
1
Research Sites
8 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 marked by long-lasting stomach and digestive symptoms without clear physical causes. They include Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often linked with ongoing pain, anxiety, and depression. Stress plays a key role by affecting nerve connections between the gut and brain. Researchers are studying Heart Rate Variability (HRV) biofeedback as a way to improve the balance of the nervous system and reduce stress and symptoms in college students with FGIDs. Participants will be randomly assigned to one of two groups: one will receive true HRV biofeedback training, which includes five sessions of 45 minutes each held every two weeks. During these sessions, participants will learn to synchronize their heart rate with their breathing using real-time feedback from ECG and respiratory signals displayed on a screen. The other group will receive placebo training with similar session timing and activities but without feedback based on their own physiological signals. Throughout the study, participants will complete psychological questionnaires and physiological recordings before treatment, after four weeks, and again three months later. Measurements will include anxiety, stress, emotion regulation, IBS severity, and heart rate variability, along with secondary outcomes like emotional state, respiratory rate, and depression. This approach will help assess whether HRV biofeedback reduces stress and gastrointestinal symptoms. The trial involves online screening and follow-up assessments over several months.
CONDITIONS
Brief Title
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Clinically significant anxiety symptoms (DASS-21 score > 4)
- Symptoms related to Functional Gastrointestinal Disorders (IBS-SSS score > 75)
- Willingness to give informed consent to participate
- No current or past diagnosis of organic gastrointestinal diseases (e.g., ulcerative colitis)
- No neurological disorders such as head trauma, degenerative diseases, or stroke
- No cardiovascular disorders including hypertension or cardiac arrhythmias
You will not qualify if you...
- Absence of clinically significant anxiety symptoms (DASS-21 score < 4)
- Absence of symptoms related to Functional Gastrointestinal Disorders (IBS-SSS score < 75)
- Not willing to give informed consent
- Presence of organic gastrointestinal diseases (current or previous diagnosis)
- Presence of neurological disorders such as head trauma, degenerative diseases, or stroke
- Presence of cardiovascular disorders including hypertension or cardiac arrhythmias
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Approximately 2 to 3 weeks
Participants undergo 5 HRV biofeedback training or placebo sessions, each lasting 45 minutes, conducted twice weekly. Physiological signals such as ECG and respiratory rate are recorded during all sessions.
5 sessions conducted biweekly (in-person)
Follow-up
Duration - 3 months
Participants are assessed for anxiety, stress, emotion regulation, irritable bowel severity, heart rate variability, and other outcomes at baseline, Week 4, and Month 3 after treatment.
3 assessment visits (in-person) at Day 0, Week 4, and Month 3
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
E
Elisabetta Patron, PsyD, PhD
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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Published Research Related To This Trial
How heart rate variability affects emotion regulation brain networks.
Mara Mather, Julian Thayer
https://pubmed.ncbi.nlm.nih.gov/29333483The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis.
V C Goessl, J E Curtiss, S G Hofmann
https://pubmed.ncbi.nlm.nih.gov/28478782