A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
- Conditions
- Functional Gastrointestinal Disorders (FGIDs)
- Registration Number
- NCT06687057
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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);
- absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
- 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).
- presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anxiety Day 0 (T0); Week 4 (T1); Month 3 (T2) The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Stress Day 0 (T0); Week 4 (T1); Month 3 (T2) The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Emotion Regulation Day 0 (T0); Week 4 (T1); Month 3 (T2) The Emotion Regulation Questionnaire (ERQ) is composed of ten items divided into two factors: cognitive reappraisal with six items and expressive suppression with four items. It is answered on a Likert scale ranging from 1 (total disagreement) to 7 (total agreement).
Irritable Bowel Severity Day 0 (T0); Week 4 (T1); Month 3 (T2) This scale evaluates primarily the intensity of IBS symptoms during a 10-day period: abdominal pain, distension, stool frequency and consist- ency, and interference with life in general. The IBS-SSS calculates the sum of these 5 items each scored on a visual analog scale from 0 to 100. Although the IBS-SSS uses patient-rated intensity of IBS symptoms, the determination of severity by the scoring system was originally anchored to a physician's assessment of patient severity.
Heart Rate Variability Day 0 (T0); Week 4 (T1); Month 3 (T2) Electrocardiogram (ECG) and Heart Rate Variability in particular, recorded through three Ag/AgCl electrodes placed with a proximal type fitting, using the second Einthoven lead. Heart rate and HRV parameters in time and frequency and nonlinear indices will be extracted from the ECG. They will also be monitored during the proposed training (experimental and control).
- Secondary Outcome Measures
Name Time Method Interception Day 0 (T0); Week 4 (T1); Month 3 (T2) The Body Perception Questionnaire (BPQ) is a self-report measure of body awareness and autonomic symptoms (i.e. symptoms experienced in organs innervated by the ANS). Its items are based on the organization of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and body.
Emotional State Day 0 (T0); Week 4 (T1); Month 3 (T2) The PANAS is a self-report measure used to assess levels of positive and negative affect. It consists of 20 items asking the extent to which the respondent has experienced different emotions during a given timeframe.
Respiratory Rate Day 0 (T0); Week 4 (T1); Month 3 (T2) Respiratory rate (RR) recorded through bands (strain gauges) placed around the chest and around the abdomen. It will be monitored during both the experimental and control treatments
Depression Day 0 (T0); Week 4 (T1); Month 3 (T2) The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).