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

Not Applicable

Completed

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

• Registration Number: NCT06205446
• Lead Sponsor: Buddhist Tzu Chi General Hospital

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-09-01
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days	Baseline and day 14	Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 14 Score - Baseline Score).
Change from Baseline on the Reflux Symptom Index (RSI) at 14 days	Baseline and day 14	Possible scores range from 0 (no symptoms) to 5 (most severe) 0= No Problem 1=very slight 2=slight 3=About medium 4=moderate to severe 5=Severe Problem Change = (day 14 Score - Baseline Score).
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days	Baseline and day 14	Possible scores range from 1 (No pain) to 4 (Worst possible pain); 1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 14 Score - Baseline Score).
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days	Baseline and day 14	Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 14 Score - Baseline Score).
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days	Baseline and day 14	Possible scores range from 1 (Never) to 5 (Always); 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days	Baseline and day 14	Possible scores range from 1 (Never) to 3 (4\~7days) 0=Never 1=1 day 2=2\~3days 3=4\~7days Change = (day 14 Score - Baseline Score).
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days	Baseline and day 14	Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days	Baseline and day 14	Possible scores range from 1 (Never) to 4 (Always); 1=Never 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days	Baseline and day 14	Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days	Baseline and day 14	Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days	Baseline and day 14	Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days	Baseline and day 14	Possible scores range from 1 (Strongly disagree) to 6 (Strongly agree); 1=Strongly agree 2=Moderately agree 3=Mildly agree 4=Mildly disagree 5 =Moderately disagree 6=Strongly disagree Change = (day 14 Score - Baseline Score).

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan