Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction

Buddhist Tzu Chi General Hospital

Status: Completed

Conditions: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders; Healthy Subjects; Laryngopharyngeal Reflux

Treatments: Behavioral: Laryngopharyngeal reflux disease subjects : abdominal breathing; Behavioral: Dyspepsia subjects : abdominal breathing; Behavioral: Healthy subjects : abdominal breathing; Behavioral: Irritable bowel disorder : abdominal breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT06205446

IRB112-185-A

Details and patient eligibility

About

Patients with disorders of gut-brain interaction (DGBI) often present gastrointestinal symptoms that do not show noticeable irregularities in standard examinations. However, due to unclear causes and a high prevalence rate, this condition often exerts a profound impact on the physical and mental health of patients. The scope of DGBI encompasses conditions such as laryngopharyngeal reflux, functional dyspepsia, and irritable bowel syndrome. Previous research has confirmed that in patients with DGBI, their autonomic nervous system exhibits an imbalance, charact erized by decreased parasympathetic activity and dominant sympathetic activity. Diaphragmatic breathing helps reduce the respiratory rate and can stimulate parasympathetic activity while suppressing sympathetic activity. Hence, it is now officially recommended as an effective adjunct therapy for relieving symptoms of gastroesophageal reflux. Accordingly, this study plans to implement a randomized controlled trial, introducing diaphragmatic breathing to patients with DGBI who exhibit normal results in objective examinations. This work allows evaluate changes in their psychophysical symptoms before and after treatment, as well as alterations in the autonomic nervous system .

Enrollment: 125 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for healthy subjects:

1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
2. No gastrointestinal symptoms or use of gastrointestinal medication.

Inclusion criteria for Laryngopharyngeal reflux disease subjects:

1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
2. Gastroesophageal reflux disease (GERD) is defined as the condition characterized by experiencing symptoms for at least three months (such as hoarseness, sensation of a foreign body in the throat, chronic cough, and frequent throat clearing) occurring at least once a week. Reflux Symptom Index (RSI) is a standardized questionnaire for evaluating laryngopharyngeal reflux. It consists of nine reflux-related symptoms, with severity scores ranging from 0 (no symptoms) to 5 (most severe). A total score exceeding 13 indicates the criteria for inclusion of a patient as having laryngopharyngeal reflux.

dyspepsia subjects:

1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
2. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia is chronic ( once a week , lasting for at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following ) : postprandial abdominal distension, easy feeling of fullness, upper abdominal pain Or upper abdominal burning sensation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).

Inclusion criteria for subjects with irritable bowel disorder:

1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
2. meet the definition of irritable bowel disorder (IBS) . Irritable bowel syndrome is chronic ( once a week , lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation , and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) .

Exclusion criteria

1. Pregnant or lactating women.
2. Infected with antibiotic resistance.
3. Received endotracheal intubation in the past two months .
4. Having myocardial ischemia or recently experienced a myocardial infarction.
5. Unable to collaborate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

abdominal breathing

Experimental group

Description:

The relationship between respiration and the autonomic nervous system (ANS) is closely intertwined, as the phrenic nerve, responsible for controlling the movement of the diaphragm, is connected to the vagus nerve of the parasympathetic nervous system.The respiratory cycle reflects the balance between the parasympathetic and sympathetic nervous systems in the Autonomic Nervous System (ANS), which can be observed through Heart Rate Variability (HRV). The ANS state shifts from the parasympathetic nervous system to the sympathetic nervous system during inhalation, while it transitions from the sympathetic nervous system to the parasympathetic nervous system during exhalation. In HRV, an increase in heart rate indicates enhanced sympathetic nervous system activity during inhalation, whereas a decrease in heart rate signifies increased parasympathetic nervous system activity during exhalation.

Treatment:

Behavioral: Irritable bowel disorder : abdominal breathing

Behavioral: Healthy subjects : abdominal breathing

Behavioral: Dyspepsia subjects : abdominal breathing

Behavioral: Laryngopharyngeal reflux disease subjects : abdominal breathing