Heart rate variability biofeedback increases baroreflex gain and peak expiratory flow.
Paul M Lehrer, Evgeny Vaschillo, Bronya Vaschillo...
https://pubmed.ncbi.nlm.nih.gov/14508023/Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-08-24
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
E
Eleonora Volpato, PsyD, PhD
E
Elisabetta Patron, PsyD, PhD
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Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
University of Padova
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Paul M Lehrer, Evgeny Vaschillo, Bronya Vaschillo...
https://pubmed.ncbi.nlm.nih.gov/14508023/Mara Mather, Julian Thayer
https://pubmed.ncbi.nlm.nih.gov/29333483/V C Goessl, J E Curtiss, S G Hofmann
https://pubmed.ncbi.nlm.nih.gov/28478782/Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
University of Padova
Collaborating Sponsor