A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Functional Gastrointestinal Disorders (FGIDs)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biofeedback

The actual administration of the HRV-Biofeedback protocol: 5 HRV biofeedback training sessions of 45 minutes each, conducted biweekly.

Group Type EXPERIMENTAL

HRV Biofeedback Training

Intervention Type BEHAVIORAL

The intervention involves 5 training sessions lasting 45 minutes (specifically, 5-minute baseline and 5 HRV biofeedback trials lasting 5 minutes each) according to the protocol published by Lehrer et al. (2013). Physiological signals (ECG and respiratory rate) will be recorded during all sessions. During the training, participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing. They will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle in order to maximize the difference between the maximum and minimum heart rate within each respiratory cycle \[i.e., respiratory sinus arrhythmia (RSA), an index of vagal modulation on the heart\] (Lehrer et al., 2003; Lehrer et al., 2000).

Placebo

Placebo condition: 5 control sessions of 45 minutes each, conducted biweekly.

Group Type PLACEBO_COMPARATOR

Placebo Training

Intervention Type OTHER

The Placebo procedure requires participants to attend 5 sessions lasting 45 minutes during which they perform a task. Physiological signals (ECG and respiration rate) will be recorded during all sessions. Participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing but these will not directly reflect the subject's cardiorespiratory activity. Participants in the control group will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle, but the feedback on the screen will not reflect that subject's RSA changes.

Interventions

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HRV Biofeedback Training

The intervention involves 5 training sessions lasting 45 minutes (specifically, 5-minute baseline and 5 HRV biofeedback trials lasting 5 minutes each) according to the protocol published by Lehrer et al. (2013). Physiological signals (ECG and respiratory rate) will be recorded during all sessions. During the training, participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing. They will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle in order to maximize the difference between the maximum and minimum heart rate within each respiratory cycle \[i.e., respiratory sinus arrhythmia (RSA), an index of vagal modulation on the heart\] (Lehrer et al., 2003; Lehrer et al., 2000).

Intervention Type BEHAVIORAL

Placebo Training

The Placebo procedure requires participants to attend 5 sessions lasting 45 minutes during which they perform a task. Physiological signals (ECG and respiration rate) will be recorded during all sessions. Participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing but these will not directly reflect the subject's cardiorespiratory activity. Participants in the control group will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle, but the feedback on the screen will not reflect that subject's RSA changes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.).

Exclusion Criteria

* 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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes